01.Cover Page-N

Post-Monsoon, 2014

M/s. ALEMBIC PHARMACEUTICALS LIMITEDAPI UNIT-I,SURVEY NO.: 119, 120 & 121,AT & POST: PANELAV, TAL: HALOL, DIST: PANCHMAHAL-389 350 (GUJ)

FINAL ENVIRONMENTAL IMPACT & RISK ASSESMENT REPORT FOR

PROPOSED EXPANSION OF APIs IN EXISTING UNIT

NABL Accredited Testing Laboratory

ISO 9001:2008 Certified Company

Aqua-Air Environmental Engineers P. Ltd.

403, Centre Point, Nr. Kadiwala School, Ring

Road, Surat – 395002 (Guj.)

Prepared By:

FINAL ENVIRONMENTAL IMPACT & RISK

ASSESSMENT REPORT

CLIENT

PROJECT TITLE

PROJECT NO.

:

:

:

M/S. ALEMBIC PHARMACEUTICALS LIMITED

API UNIT-I,

SURVEY NO.: 119, 120 & 121,

AT & POST: PANELAV, TAL: HALOL,

DIST: PANCHMAHAL-389 350 (GUJ)

FINAL ENVIRONMENTAL IMPACT & RISK ASSESMENT REPORT FOR


432000





Road, Surat - 395002

Prepared By:











Prepared By:

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INDEX

SR. NO. TITLE PAGE NO.

1 CHAPTER 1: INTRODUCTION

1.1 JUSTIFICATION & BACKGROUND 1‐1

1.1.1 PROMOTERS & THEIR BACKGROUND 1‐2

1.1.2 REGULATORY FRAMEWORK 1‐3

1.2 PROJECT SETTING 1‐11

1.2.1 KEY INFRASTRUCTURAL FEATURES AND SETTLEMENTS 1‐12

1.2.1.1 METHOD OF DATA PREPARATION 1‐12

1.2.1.2 DISTANCE OF NEAREST KEY INFRASTRUCTURE FEATURES FROM PROJECT

SITE

1‐12

1.2.1.3 MAP OF KEY INFRASTRUCTURE FEATURES AND SETTLEMENTS 1‐13

1.3 PURPOSE OF EIA 1‐15

1.4 OBJECTIVES OF EIA 1‐15

1.5 METHODOLOGY FOR EIA 1‐15

1.5.1 BASE LINE ENVIRONMENTAL CONDITION 1‐15

1.5.1.1 AMBIENT AIR ENVIRONMENT 1‐15

1.5.1.2 GROUND AND SURFACE WATER ENVIRONMENT 1‐16

1.5.1.3 NOISE ENVIRONMENT 1‐16

1.5.1.4 SOIL ENVIRONMENT 1‐16

1.5.1.5 BIOLOGICAL ENVIRONMENT 1‐16

1.5.1.6 SOCIO‐ECONOMIC ENVIRONMENT 1‐16

1.5.2 IDENTIFICATION OF POLLUTION SOURCE 1‐17

1.5.3 EVALUATION OF POLLUTION CONTROL AND ENVIRONMENTAL

MANAGEMENT SYSTEM

1‐17

1.5.4 EVALUATION OF IMPACT 1‐17

1.5.5 PREPARATION OF ENVIRONMENTAL MANAGEMENT PLAN 1‐17

1.6 STRUCTURE OF REPORT 1‐17

2 CHAPTER 2: PROJECT DESCRIPTION AND INFRASTRUCTURAL FACILITIES

2.1 BACKGROUND 2‐1

2.2 MANUFACTURING ACTIVITIES 2‐1 to 2‐184

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2.3 RAW MATERIAL CONSUMPTION, STORAGE AND HANDLING 2‐185 to 2‐204

2.4 INFRASTRUCTURE FACILITIES 2‐205

2.4.1 LAND 2‐205

2.4.2 TRANSPORTATION FACILITIES 2‐205

2.4.3 WATER AND WASTEWATER 2‐205

2.4.3.1 TREATMENT PROCESS 2‐209

2.4.4 AIR POLLUTION AND CONTROL SYSTEM 2‐220

2.4.5 NOISE LEVEL AND CONTROL SYSTEM 2‐221

2.4.6 HAZARDOUS AND SOILD WASTE GENERATIONS AND DISPOSAL SYSTEM 2‐221

2.5 DETAILS OF UTILITIES 2‐224

2.6 ELECTRICITY REQUIREMENT & FUEL REEQUIREMENT 2‐224

3 CHAPTER 3: BASELINE ENVIRONMENTAL STATUS

3.1 MICRO‐METEOROLOGY OF THE AREA 3‐1

3.1.1 TEMPERATURE DETAILS 3‐2

3.1.2 RELATIVE HUMIDITY (RH) 3‐3

3.1.3 RAINFALL 3‐4

3.1.4 WIND SPEED 3‐5

3.2 AIR ENVIRONMENT 3‐9

3.2.1 DESIGN OF NETWORK FOR AMBIENT AIR QUALITY MONITORING

LOCATIONS

3‐9

3.2.2 METHODOLOGY FOR AMBIENT AIR QUALITY MONITORING 3‐10

3.3 NOISE ENVIRONMENT 3‐16

3.3.1 METHODOLOGY FOR NOISE MONITORING 3‐16

3.4 WATER ENVIRONMENT 3‐21

3.4.1 RECONNAISSANCE 3‐21

3.4.2 METHODOLOGY FOR WATER QUALITY MONITORING 3‐21

3.5 LAND ENVIRONMENT 3‐26

3.5.1 METHODOLOGY FOR SOIL MONITORING 3‐26

3.5.2 SOIL CLASSIFICATIONS 3‐29

3.5.2.1 METHOD OF PREPARATION 3‐29

3.5.2.2 DESCRIPTION OF SOIL CHARACTERISTICS AND AREA UNDER DIFFERENT

SOIL TYPES

3‐29

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3.5.2.3 SOIL CHARACTERISTICS MAP 3‐29

3.6 GEOLOGICAL DATA 3‐32

3.6.1 METHOD OF PREPARATION 3‐32

3.6.2 DESCRIPTION OF GEOLOGICAL CLASSIFICATION AND AREA UNDER

DIFFERENT FORMATIONS

3‐32

3.6.3 GEOLOGICAL MAP 3‐32

3.7 LAND USE PATTERN 3‐34

3.7.1 METHOD OF DATA PREPARATION 3‐34

3.8 ECOLOGICAL INFORMATION 3‐39

3.8.1 PHYSIOGRAPHY 3‐39

3.8.2 FOREST 3‐40

3.8.3 METHOD OF PREPARATION 3‐40

3.8.4 AREA UNDER DIFFERENT VEGETATION CLASSIFICATION 3‐40

3.8.5 AREA UNDER FORESTS AND SANCTUARY 3‐40

3.8.6 FLORA 3‐43

3.8.7 FAUNA 3‐44

3.9 SOCIO‐ECONOMIC ENVIRONMENT 3‐44

3.9.1 SETTLEMENTS AND DEMOGRAPHIC PATTERN 3‐45

3.9.1.1 METHOD OF DATA PREPARATION 3‐45

3.9.1.2 DEMOGRAPHIC DATA WITHIN THE REGION 3‐45

3.9.1.3 LITERACY RATE 3‐49

3.9.2 OCCUPATIONAL STRUCTURE 3‐53

3.9.3 AMENITIES 3‐55

4 CHAPTER 4: ANTICIPATED ENVIRONMENTAL IMPACTS & MITIGATION MEASURES

4.1 IDENTIFICATION OF IMPACTS 4‐1

4.2 EVALUATION AND PREDICTION OF IMPACTS 4‐8

4.2.1 WATER ENVIRONMENT 4‐8

4.2.2 AIR ENVIRONMENT 4‐9

4.2.3 NOISE ENVIRONMENT 4‐30

4.2.4 HAZARDOUS WASTE DETAILS 4‐30

4.2.5 INFRASTRUCTURE AND SERVICES 4‐30

4.2.6 ENVIRONMENTAL HAZARDS 4‐31

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4.2.7 HOUSING 4‐31

4.2.8 ECOLOGY 4‐31

4.3 MATRIX REPRESENTATION 4‐36

4.4 CONCLUSION 4‐41

5 CHAPTER 5: ENVIRONMENTAL MONITORING PLAN

5.1 ENVIRONMENTAL MONITORING PLAN 5‐1

5.1.1 LABORATORY FACILITIES 5‐3

5.1.2 DOCUMETATION & RECORDS 5‐3

6 CHAPTER 6: ADDITIONAL STUDIES (RISK ASSESSMENT & DMP)

6.1 RISK ASSESSMENT 6‐1

6.1.1 INTRODUCTION 6‐1

6.1.2 APPROACH TO THE STUDY 6‐1

6.1.3 METHODOLOGY 6‐2

6.1.4 HAZARD IDENTIFICATION 6‐4

6.1.5 CONSEQUENCE ANALYSIS 6‐15

6.1.6 RISK ASSESSMENT SUMMARY 6‐53

6.1.7 OTHER RISK REDUCTION OPPORTUNITIES 6‐56

6.1.8 RECOMMENDATIONS FOR ALARP 6‐56

6.1.9 FIRE FIGHTING SYSTEM 6‐57

6.2 DISASTER MANAGEMENT PLAN 6‐58

6.3 COMMMUNICATION SYSTEM 6‐68

6.4 ACTION ON SITE 6‐72

6.5 OFF – SITE EMERGENCY PLAN 6‐83

6.6 OCCUPATIONAL HEALTH AND SAFETY 6‐86

6.7 TRAINING, REHERASAL & RECORDS 6‐95

6.8 HAZOP STUDY 6‐97

7 CHAPTER 7: ENVIRONMENTAL MANAGEMENT PLAN

7.1 BACKGROUND 7‐1

7.2 OBJECTIVES OF ENVIRONMENTAL MANAGEMENT PLAN 7‐1

7.3 ENVIRONMENTAL MANAGEMENT CELL 7‐2

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7.3.1 ENVIRONMENT POLICY 7‐4

7.3.2 CORPORATE ENVIRONMENT RESPONSIBILITY 7‐4

7.3.3 MANAGEMENT RESPONSIBILITY 7‐5

7.4 ENVIRONMENTAL MANAGEMENT PLAN 7‐7

7.4.1 CONSTRUCTION PHASE 7‐7

7.4.2 WATER ENVIRONMENT 7‐10

7.4.3 AIR ENVIRONMENT 7‐11

7.4.4 NOISE ENVIRONMENT 7‐15

7.4.5 LAND ENVIRONMENT 7‐17

7.5 GREEN BELT DEVELOPMENT 7‐19

7.6 OCCUPATIONAL HEALTH AND SAFETY 7‐22

7.7 INFORMATION FOR RAIN WATER HARVESTING 7‐23

7.8 MEASURES FOR CONSERVATION OF ENERGY 7‐25

7.9 NATURAL RESOURCES CONSERVATION 7‐26

7.10 SKILLED AND TRAINED MANPOWER 7‐27

7.11 SOCIO ECONOMIC DEVELOPMENT ACTIVITIES 7‐27

7.12 SOLVENT RECOVERY PLAN 7‐30

7.13 METHODOLOGY OF DE‐CONTAMINATION AND DISPOSAL OF DISCARDED

CONTAINERS AND ITS RECORD KEEPING

7‐33

7.14 CAPITAL COST FOR ENVIRONMENTAL MANGEMENT 7‐34

7.15 COMPLIANCE TO THE RECOMMENDATIONS MENTIONED IN THE CREP

GUIDELINES

7‐34

8 CHAPTER 8: EXECUTIVE SUMMARY

8.1 SUBJECT 8‐2

8.2 PRODUCT AND CAPACITY 8‐2

8.3 WATER REQUIREMENT, WASTE WATER GENERATION AND TREATMENT 8‐4

8.4 AIR POLLUTION SOURCE AND CONTROL MANAGEMENT 8‐4

8.5 HAZARDOUS WASTE 8‐4

8.6 GREEN BELT 8‐4

8.7 POWER & FUEL REQUIREMENTS 8‐5

8.8 STORAGE DETAILS OF HAZARDOUS CHEMICALS 8‐5

8.9 CAPITAL AND RECURRING COST EARMARKED FOR ENVIRONMENTAL 8‐5

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PROTECTION MEASURES

8.10 BASELINE ENVIRONMENTAL STATUS 8‐6

8.11 CONCLUSION 8‐9

9 CHAPTER 9: DISCLOSURE OF CONSULTANTS ENGAGED

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LIST OF TABLES

TABLE

NO.

TITLE PAGE NO.

1.1 BREAK UP OF PROJECT COST 1‐4

1.2 LAND BREAKUP 1‐4

1.3 LIST OF PRODUCTS ALONGWITH PRODUCTION CAPACITY 1‐9

1.4 DISTANCE OF NEAREST KEY INFRASTRUCTURE FEATURES FROM PROJECT

SITE

1‐12

2.1 RAW MATERIAL REQUIREMENT 2‐185 to 2‐204

2.2 WATER CONSUMPTION & WASTE WATER GENERATION 2‐206

2.3 HAZARDOUS & SOILD WASTE GENERATION QUANTITY, PHYSICAL

CHARACTERISTICS AND MODE OF DISPOSAL

2‐222 to 2‐223

3.1 TEMPERATURE DETAILS 3‐2

3.2 RELATIVE HUMIDITY DETAILS 3‐3

3.3 RAINFALL DETAILS 3‐4

3.4 WIND SPEED DETAILS 3‐5

3.5 SITE SPECIFIC METEOROLOGICAL DATA 3‐6

3.6 DETAILS OF AMBIENT AIR QUALITY MONITORING LOCATIONS 3‐11

3.7 AMBIENT AIR QUALITY STATUS 3‐13 to 3‐15

3.8A DETAILS OF AMBIENT NOISE QUALITY MONITORING LOCATIONS 3‐17

3.8B BACKGROUND NOISE LEVELS 3‐19

3.9 NOISE LEVELS DUE TO TRANSPORTATION 3‐19

3.10 SAMPLING LOCATIONS FOR MONITORING SURFACE WATER AND GROUND

WATER QUALITY

3‐22

3.11 WATER QUALITY‐ PHYSICAL PARAMETERS 3‐24 to 3‐25

3.12 SAMPLING LOCATIONS: SOIL QUALITY 3‐26

3.13 PHYSICO‐CHEMICAL CHARACTERISTICS OF SOIL 3‐28

3.14 SOIL CHARACTERISTICS UNDER PROJECT AREA 3‐29

3.15 GEOLOGICAL FEATURES 3‐32

3.16 AREAS UNDER DIFFERENT LANDUSE 3‐36

3.17 FLORA 3‐43

3.18 FAUNA 3‐44

3.19 DEMOGRAPHIC DATA 3‐45

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3.20 POPULATION DENSITY 3‐47

3.21 LITERACY RATE 3‐49

3.22 OCCUPATIONAL STRUCTURE 3‐53

3.23 DETAILS OF AMENITIES AVAILABLE IN THE STUDY AREA 3‐56

4.1 DETAILS OF EMISSION FROM STACKS 4‐10 to 4‐12

4.2 SUMMARY OF ISCST3 MODEL OUTPUT FOR SPM, SO2, NOX , HCL 4‐21 to 4‐22 &

4‐29

4.3 PREDICTED AMBIENT AIR QUALITY FOR SPM, SO2, NOX, HCL 4‐30

4.4 IMPACT IDENTIFICATION MATRIX 4‐37 to 4‐38

4.5 CONSTRUCTION & OPERATION STAGE POTENTIAL IMPACTS & MITIGATIVE

MEASURES

4‐39

4.6 ENVIRONMENTAL IMPACT MATRIX 4‐40

4.7 CUMULATIVE IMPACT CHART 4‐41

5.1 PROJECT ENVIRONMENT MONITORING PLAN 5‐2

6.1 STORAGE DETAILS OF HAZARDOUS CHEMICALS 6‐7

6.2 OTHER HAZARDS AND CONTROL 6‐8

6.3 PROPERTIES OF CHEMICALS 6‐9

6.4 POSSIBLE ACCIDENT SCENARIOS 6‐25

7.1 ENVIRONMENT MANAGEMENT PLAN 7‐9

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LIST OF FIGURES

FIGURE

NO.

TITLE PAGE NO.

1.1 LOCATION OF THE PROJECT SITE 1‐6 to 1‐7

1.2 PLANT LAYOUT 1‐8

1.3 KEY INFRASTRUCTURE FEATURES AND SETTLEMENTS 1‐14

1.4 ACTIVITIES, SOURCES OF INFORMATION AND CONTENTS OF EIA REPORT 1‐19

3.1 WIND ROSE DIAGRAM & STABILITY CLASS DISTRIBUTION 3‐7 to 3‐8

3.2 LOCATION OF AMBIENT AIR QUALITY MONITORING STATIONS 3‐12

3.3 LOCATION OF NOISE LEVEL MONITORING STATIONS 3‐18

3.4 LOCATIONS OF WATER SAMPLING STATIONS 3‐23

3.5 LOCATIONS OF SOIL SAMPLING STATIONS 3‐27

3.6 SOIL CHARACTERISTICS MAP 3‐31

3.7 MAJOR GEOLOGICAL FEATURES 3‐33

3.8 LAND USE/ LAND COVER 3‐37

3.9 LANDUSE / LANDCOVER WITH VILLAGE LOCATIONS 3‐38

3.10 FOREST MAP 3‐41

3.11 VEGETATION DENSITY MAP WITH VILLAGE LOCATION 3‐42

3.12 POPULATION DENSITY 3‐48

3.13 LITERACY DATA 3‐52

4.1 IMPACT NETWORK 4‐2 to 4‐7

4.2 ISOPLETHS 4‐13 to 4‐20

&

4‐23 to 4‐28

6.1 QRA METHODOLOGY 6‐2

6.2 FLOW CHART FOR QUANTITATIVE RISK ASSESSMENT 6‐3

6.3 SITE PLAN 6‐6

7.1 ORGANOGRAM OF ENVIRONMENT MANAGEMENT CELL 7‐3

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COPY OF TORs FROM MoEF, NEW DELHI

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COMPLIENCE OF TERMS OF REFERENCES (TORs)

Sr. No.

TOR Point Compliance Status

1 Executive summary of the project Refer Chapter – 8

2 Justification of the project Refer Chapter – 1, Page 1‐1

3 Project location and plant layout Refer Chapter – 1, Page 1‐6 to 1‐8

4 Promoters and their back ground Refer Chapter – 1, Page 1‐2

5 Regulatory framework Refer Chapter – 1, Page 1‐3

6 A map indicating location of the project and distance from severely polluted area

Refer Chapter – 1, Page 1‐14

7 Infrastructure facilities including power sources Refer Chapter – 2, Page 2‐205 & 2‐225

8 Total cost of the project alongwith total capital cost and recurring cost/annum for environmental pollution control measures


9 Project site location alongwith site map of 10 km area and site details providing various industries, surface water bodies, forests etc

Refer Chapter – 1, Page 1‐6 to 1‐7 & 1‐14

10 Present land use based on satellite imagery for the study area of 10 km radius

Refer Chapter – 3, Page 3‐34 to 3‐38

11 Location of National Park/Wild life sanctuary/Reserve Forest within 10 km radius of the project


12 Details of the total land and break‐up of the land use for green belt and other uses


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13 List of products alongwith the production capacities Refer Chapter – 1, Page 1‐9 to 1‐10

14 Detailed list of raw material required and source, mode of storage and transportation


15 Manufacturing process details alongwith the chemical reactions and process flow chart


16 Site‐specific micro‐meteorological data using temperature, relative humidity, hourly wind speed and direction and rainfall is necessary


17 Ambient air quality monitoring at 6 locations within the study area of 5 km., aerial coverage from project site as per NAAQES notified on 16th September, 2009. Location of one AAQMS in downwind direction


18 One season site‐specific micro‐meteorological data using temperature, relative humidity, hourly wind speed and direction and rainfall and AAQ data (except monsoon) for PM10, SO2, NOx including HC and VOCs should be collected. The monitoring stations should take into account the pre‐dominant wind direction, population zone and sensitive receptors including reserved forests. Data for water and noise monitoring should also be included



19 Air pollution control measures proposed for the effective control of gaseous emissions within permissible limits


20 Name of all the solvents to be used in the process and details of solvent recovery system


21 Design details of ETP, incinerator, boiler, scrubbers/bag filters etc Refer Chapter – 2, Page 2‐209 to 2‐219

22 Details of water and air pollution and its mitigation plan Refer Chapter – 7, Page 7‐10 to 7‐13

I- 18

23 Action plan to control ambient air quality as per NAAQES Standards notified by the Ministry on 16th September, 2009


24 An action plan to control and monitor secondary fugitive emissions from all the sources


25 Determination of atmospheric inversion level at the project site and assessment of ground level concentration of pollutants from the stack emission based on site specific meteorological features. Air quality modelling for proposed plant


26 Source and permission for the drawl of total 397.5 m3/day water from the competent authority. Water balance chart including quantity of effluent generated recycled and reused and discharged. Efforts shall be made to reduce ground water drawl

Source of Water: Ground Water Refer Chapter – 2, Page 2‐205 to 2‐208 Refer Annexure ‐ 7

27 Action plan for ‘Zero’ discharge of effluent should be included Refer Chapter – 2, Page 2‐205 to 2‐219 28 Ground water quality monitoring minimum at 6 locations should be

carried out. Geological features and Geo‐hydrological status of the study area and ecological status (Terrestrial and Aquatic)

Refer Chapter – 3, Page 3‐21 to 3‐25 & 3‐32 to 3‐33

29 The details of solid and hazardous wastes generation, storage, utilization and disposal particularly related to the hazardous waste calorific value of hazardous waste and detailed characteristic of the hazardous waste


30 Action plan for the management of fly ash generated from boiler should be included. Tie‐up or agreement with brick manufacturer to be provided

There is no fly ash generation from the unit so it is Not Applicable

31 Precautions to be taken during storage and transportation of hazardous chemicals should be clearly mentioned and incorporated

Refer Chapter – 6, Page 6‐7 & 6‐13 to 6‐15

32 A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearly that they will utilized all the organic solid waste generated

Refer Annexure ‐ 8

33 A copy of ‘Memorandum of Understanding’ (MoU) signed with coal supplier for imported coal and brick manufacturers for management of fly ash


34 Authorization/Membership for the disposal of liquid effluent in CETP and solid/hazardous waste in TSDF, if any


35 Material Safety Data Sheet for all the Chemicals are being used/will be used. CAS No./RTECS No./DOT/UN etc to be mentioned against each chemicals


36 Authorization/Membership for the disposal of solid/hazardous waste in TSDF


37 Risk assessment for storage for chemicals/solvents. Action plan for handling & safety system

Refer Chapter – 6, Page 6‐25 to 6‐57 Page 6‐11 to 6‐15

38 An action plan to develop green belt in 33 % area. Layout plan for green belt shall be provided


39 Action plan for rainwater harvesting measures at plant site shall be included to harvest rainwater from the roof tops and storm water drains to recharge the ground water


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Details of occupational health programme i) To which chemicals, workers are exposed directly or indirectly ii) Whether these chemicals are within Threshold Limit Values (TLV)/ Permissible Exposure Levels as per ACGIH recommendation iii) What measures company have taken to keep these chemicals within PEL/TLV iv) How the workers are evaluated concerning their exposure to chemicals during pre‐placement and periodical medical monitoring v) What are onsite and offsite emergency plan during chemical disaster vi) Liver function tests (LFT) during pre‐placement and periodical examination

40

vii) Details of occupational health surveillance programme

Refer Chapter – 6, Page 6‐86 to 6‐95 Refer Chapter – 7, Page 7‐22 to 7‐23

41 Socio‐economic development activities should be in place Refer Chapter – 7, Page 7‐27 to 7‐28 42 Note on compliance to the recommendations mentioned in the CREP

guidelines Refer Chapter – 7, Page 7‐32 to 7‐33

43 Detailed Environment management Plan (EMP) with specific reference to details of air pollution control system, water & wastewater management, monitoring frequency, responsibility and time bound implementation plan for mitigation measure should be provided

Refer Chapter – 5, Page 5‐2 Refer Chapter – 7

44 EMP should include the concept of waste‐minimization, recycle / reuse / recover techniques, Energy conservation, and natural resource conservation

Refer Chapter – 7, Page 7‐18, 7‐25 to 7‐27

45 Any litigation pending against the project and/or any direction/order passed by any Court of Law against the project, if so, details thereof

Not Applicable

Additional TOR 1 A separate chapter on status of compliance of Environmental Conditions

earlier granted by Centre to be provided. As per circular dated 30th May, 2012 issued by MoEF, a certified report by RO, MoEF on status of compliance of conditions on existing unit to be provided in EIA/EMP report

Copy of Report & its Compliance is attached Separately, Refer Annexure ‐ 10

2 Public hearing to be conducted by SPCB and issues raised and commitments made by the project proponent on the same should be included in EIA/EMP Report in the form of tabular chart with financial budget for complying with the commitments made

Public Hearing Minutes is attached Separately, Refer Annexure ‐ 11

A tabular chart with index for point wise compliance of above TORs Complied as above The following general points shall be noted i. All documents shall be properly indexed, page numbered Complied ii. Period/date of data collection shall be clearly indicated Complied iii. Authenticated English translation of all material provided in Regional

languages Complied

iv. The letter/application for EC shall quote the MOEF file No. and also attach a copy of the letter.

Complied

v. The copy of the letter received from the Ministry shall be also attached as an annexure to the final EIA‐EMP Report

Complied

vi. The final EIA‐EMP report submitted to the Ministry must incorporate the issues in this letter. The index of the final EIA‐EMP report must indicate the specific chapter and page no. of the EIA‐EMP Report

Complied

vii. Certificate of Accreditation issued by the QCI to the environmental consultant shall be included

Copy of Hon ‘able High Court’s Stay Order & Extensions attached as Annexure‐13

1-1

CHAPTER ‐ 1 ___________________________________________________________________________ INTRODUCTION 1.1 JUSTIFICATION AND BACKGROUND

M/s. Alembic Pharmaceuticals Limited (Unit‐I) proposes expansion of APIs in Existing Unit

at Survey No. 119, 120 & 121, At & Post: Panelav, Tehsil: Halol, Dist. Panchmahal, Gujarat.

The Unit shall maintain the environment, quality of its product, Safety & House Keeping of

the site. This project will generate additional employment and secondary business

opportunity in this region. This unit would cater to the domestic market and there by

reducing dependencies on Import. Existing project cost is Rs. 34.41 Crores and cost for

proposed expansion project activity shall be Rs. 36.81 Crores. Capital Cost of Air & Water

Pollution Control System and Environmental Monitoring Equipments will be Rs. 4.32 Crores.

Alembic group is manufacturer & exporter of bulk drugs, bulk drug intermediates &

pharmaceutical Formulations. It is a government recognized “Export House”. Existing unit of

Bulk drugs of M/s. Alembic Pharmaceuticals Limited (API DIV – Unit‐I) is located at Panelav,

Tal: Halol, Dist. Panch Mahal‐389 350, Gujarat state.

Alembic, founded in 1907, is committed to excellence in pharmaceutical healthcare through

the development of indigenous technologies, with a mission to give access to the best

healthcare products at affordable prices to everyone, anywhere in the world. Alembic is one

of India's most experienced manufacturers of bulk drugs and pharmaceutical formulations in

human and animal healthcare, as well as a respected export house. The leadership position

that Alembic's products enjoy in their respective categories speak aloud of the quality and

service standards set by the company. Six of Alembic's brands feature among the top 300

brands in the country today.

Alembic was a pioneer in the basic manufacture of penicillin. It is a world leader in

Macrolides and has the distinction of producing Cephalosporin – C for the first time in the

country. Alembic's brand, Althrocin, is India's 3rd largest antibiotic. The major therapeutic

segments where Alembic has a strong presence are antibiotics and antibacterials, cough and

cold remedies, analgesic and anti‐inflammatory medications, nutraceuticals and anti‐

1-2

diabetics. Alembic unveils the country's first zero calorie sugar substitute and Alembic is the

first company in India to introduce Ucralose. Alembic is a certified WHO‐GMP and USFDA

company with manufacturing practices and facilities that conform to WHO‐GMP guidelines.

The Panelav facility has been upgraded and has received the approval of International

Regulatory authorities such as the Medicines Control Agency, UK, Medicines Control

Council, South Africa and the Food and Drug Administration, USA.

Panelav unit of M/s. Alembic Pharmaceuticals Limited (API Div – Unit‐I) established in 1996.

In order to meet the growing market demand of bulk drugs and pharmaceutical

formulations and availability of space for manufacturing facility for bulk drugs at existing

plant, M/s. Alembic Pharmaceuticals Limited (API Div – Unit‐I) proposes to expand

manufacturing activities by increasing production capacity with expansion of bulk drugs at

existing bulk drugs unit.

1.1.1 PROMOTERS AND THEIR BACK GROUND

M/s. Alembic Pharmaceuticals Limited (Unit‐I) is a Ltd. company, having eight directors. The

detail of project proponent is as below:

Sr.

No.

Name and Designation Address Phone No.

1. Shri Chirayu Ramanbhai Amin

(Chairman & MD)

F 10/195, Race Course Circle, Gotri

Road, Vadodara – 390 007

2280506 (O)

2336308 (R)

2. Smt. Malika Chirayu Amin

(Whole Time Director)

F 10/195, Race Course Circle, Gotri

Road, Vadodara – 390 007

3. Dr. Babubhai Rambhai Patel

(Director)

“EL CID” Nr. Hydraulic Research

Laboratory, Gotri Road, Vadodara –

390 015

2313830 (R)

4. Shri Ranijitbhai Rambhai Patel

(Director)

“Shivam”, Near Shivmahal Palace,

Old Padra Road, Vadodara – 390 015

2307294 (O)

2282474 (D)

2313438 (R)

1-3

5. Shri Ramanbhai Maganlal

Kapadia

(Director)

49/50, Matri Mandir Society, Near

Dutt Mandir, ISCKON Temple Road,

Off Gotri Road, Vadodara – 390 021

2307633(O)

2285124(D)

2340901(R)

6. Shri Pranav Natverlal Parikh

(Director)

Chairman & Managing Director,

Technova Imaging Systems Ltd.,

Laxmi Mills Estate, Off. Dr. E. Moses

Road, Mahalaxmi, Mumbai – 400

011

022‐24974124 (O)

022‐23634613 (R)

022‐23677868 (R)

9820076700 (Mobile)

022‐23637497(Fax)

Email:

[email protected]

7. Shri Raj Kumar Baheti

(Director)

Arihant Flats, 2nd Floor,

27, Sevak Nagar, Behind GEB Office,

Race Course Circle, Vadodara – 390

007

8. Shri K. G. Ramanathan

(Director)

192, Jolly Marker 3, 119, Cuffe

Parade, Mumbai

022‐22855712 (O)

022‐22847337 (O)

022‐22160655 (R)

1.1.2 REGULATORY FRAMEWORK For proposed expansion project; following assumptions has been considered:

a. Capacity of Plant 75 MT/Month

b. Total working days in a year 330

c. Raw material storage facility for one month

d. Finished product storage for 50 tons

e. Solvent Storage facility for 30 days

1-4

TABLE 1.1

BREAK‐UP OF PROJECT COST

SR.

NO.

PARTICULARS ESTIMATED COST

(INR IN CRORES)

1 Plant, Machineries, Equipments, Utilities, etc. 32.49

2 Environment protection measures (includes cost of

ETP, Tree Plantation, Evaporator System and Rain

Water Harvesting, etc.)

4.32

Total 36.81

Total Project Cost for proposed expansion project activity is Rs. 36.81 Crores. Capital cost of

air & water pollution control system and environmental monitoring equipments will be Rs.

4.32 Crores.

TABLE 1.2

BREAK UP OF DIFFERENT LAND USE OF FACTORY

Plot Wise Area

Existing Propose

Sr. No. Plant

Area Sq. Mt

Sr. No. Plant

Area Sq. Mt

1 Security and adm Building 170.72 1 New ETP (150 KLD) 1500

2 Ware house 2345.99 2 Plant, Machineries, Equipments, Utilities 968

3 FO Diesel storage yard 167.71 4 Solvent storage yard 806.50 5 HCl/Caustic Storage Yard 268.36 6 Canteen‐Micro lab & QA building 1321.86 7 Main Production block‐1 5711.42 8 Utility building 1254.50 9 DG Set/ Substation high tension transformer Yard 251.76

10 Raw Water Storage, Fire Water Storage, Pump house overhead tank 342.80

11 Cooling tower‐1 45.29 12 Effluent treatment Plant 902.08 13 Main Production block‐3 1023.92

1-5

14 AZ Plant 195.95 15 Baby boiler room 24.08 16 Evaporator building 667.80 17 Main production Block‐5 1216.14 18 Main Production Block‐4 1005.33 19 Solvent recovery Bulding‐1 964.23 20 Solvent recovery Bulding‐2 1021.29 21 Cooling Tower‐2 138.83 22 Main Production Block‐2 5614.04

23 Electrical Panel Room & incinerator plant & Incinerator Room 376.34

24 Solid Waste Room 23.05 25 Drum Storage Yard 136.00 26 DG Room 180.00 27 API health Center 220.08 28 Plant‐6 441.18 29 Hot oil System Building 30.00 30 H2/ N2 cylinder Storage Yard 48.75 31 Day tank Area 471.02 32 ETP MCC room 37.73 33 Workshop 467.98 34 Cooling Tower‐3 89.15 35 Cabin 21.00 36 Boiler House 758.22

Total 28761.10

Total Land Area 68530.26 Sq. Mt.

Ground Floor 18460.56 Upper Floor 10300.51 Green Belt 24000.00

1-6

FIGURE ‐ 1.1

LOCATION OF THE PROJECT SITE

Project Site

•Panelav

1-7

1-8

FIGURE ‐ 1.2 LAYOUT OF THE PLANT

1-9

TABLE 1.3

LIST OF PRODUCTS ALONG WITH PRODUCTION CAPACITY

Sr. No.

Product Existing (MT/Month)

Total after Proposed Expansion (MT/Month)

1 Clarithromycin 2 Azithromycin 3 Roxythromycin 4 Venlafaxine 5 Fenofibrate 6 Irbesartan 7 Valsartan 8 Telmisartan 9 Clonidine Hydrochloride 10 Modafinil 11 Leflunomide 12 Alendronate Sodium 13 O Desmethyl Venlafaxine 14 Meprobamate 15 Vildagliptin 16 Rivastigmine Tartrate 17 Topiramate 18 Lacosamide 19 Pramipexole Dihydrochloride Monohydrate 20 Olmesartan Medoxomil 21 Linezolid 22 Lercanidipine Hydrochloride 23 Fluxetine Hydrochloride 24 Deferasirox 25 Ropinorole Hydrochloride 26 Hydrochlorothiazide 27 Lamotrigine 28 Metoprolol Tartrate 29 Metoprolol Succinate 30 Quetiapine Fumarate 31 Pentosan Polysulphate Sodium 32 Levetiracetam 33 Famotidine

25

34 Memantine HCl 35 Pregabalin 36 Ivabradine 37 Azilsartan 38 Etoricoxib 39 Derifenacin

0

75

1-10

40 Celecoxib 41 Rabeprazole Sodium 42 Clopidogrel Bisulfate 43 Felodipine 44 Prasugrel Hydrochloride 45 Mexiletine Hydrochloride 46 Warfarin 47 Bazedoxifene 48 Bosentan 49 Febuxostate 50 Dronedarone 51 Dabigatran 52 Rivaroxaban 53 Asenapine 54 Silosodine 55 Zolmitriptan 56 Iloperidone 57 Agomelatine 58 Ticagrelor 59 Metaxalon 60 Vilazodone Hydrochloride 61 Teriflunomide 62 Nisoldipine 63 Fesoterodine Fumarate 64 Minodronic acid 65 Erlotinib 66 Gefitinib Total 25 75

1-11

1.2 PROJECT SETTING

M/s. Alembic Pharmaceuticals Limited (Unit‐I) located at longitude 73° 28’ 4.02” E and

latitude 22° 27’ 9.48” N. Detailed Layout map of the plant is shown in Figure – 1.2.

Project site, where M/s. Alembic Ltd. (API DIV I) is located, comes under Panch Mahal

District, which is 40 km from Nandesari GIDC an important industrial estate of Gujarat and

India. In addition, Vadodara is a major centre of pharmaceutical and glass industry in India;

the basic chemical industry is also a growing one. At Koyali nearby is a large oil‐refinery and

petro‐chemical‐based industries; while at Bajwa there is a fertilizer factory.

Halol city is about 5.5 km away and has population of around 2,37,959. The city is well

connected by road and rail to rest of India. Development of Communication systems is good

in the region due to proximity to Halol. Sources of water in the region include river and

ground water resources. The river Vishwamitri is flowing 3.2 km distance in the west

direction of the project site. "Champaner", world heritage place is located about 8 km aerial

distance from the project site but "Champaner" is located in NE direction of "Pavagadh"

mountain while the project is located in SW of "Pavagadh" mountain. Secured land fill site

and Common Incineration facility operated by M/s Nandesari Environment Control Ltd. is

located in Nandesari, GIDC Estate, about 40 km away from the project site.

The salient features of the site are as under:

1. Minimum distances:

a) From City : Halol (5.5 km)

(Population – 2,37,959 as per 2011 census data)

b) Historical Site : Champaner (World Heritage Palce) (8 km)

c) Sanctuaries : Jambughoda Wildlife Sanctuary (29 km)

d) Highway : National Highway No. 8 (41 km West),

State Highway SH 194 (1.37 km West)

e) Railway Line : 5.59 km North‐East

2. Use of forest land : None

3. Use of prime agricultural land: None

4. Planned submergence : None

5. Displacement of population : None

1-12

1.2.1 KEY INFRASTRUCTURE FEATURES AND SETTLEMENTS

1.2.1.1 METHOD OF DATA PREPARATION

Key infrastructure features have been extracted from Survey of India (SoI) topographical

maps of 1:50,000 scale. The features have been updated using satellite data and have been

verified with ancillary information derived from TTK maps and guide maps. The locations of

the settlement have been extracted from Census of India (CoI) maps and verified by using SoI

topographical maps and satellite data.

1.2.1.2 DISTANCE OF NEAREST KEY INFRASTRUCTURE FEATURES FROM PROJECT SITE

The distance of railways and National and State highways are presented in Table 1.4 below.

TABLE 1.4 ___________________________________________________________________________ DISTANCE OF NEAREST KEY INFRASTRUCTURE FEATURES FROM PROJECT SITE

Sr. No. Nearest Infrastructure Feature Distance from Project Site

1. National Highway NH 8 41 km West 2. State Highway SH 194 1.37 km West 3. Railway Line 5.59 km North‐East 4. Halol Railway Station 5.80 km North‐East 5. River Pratappura Talav 8.67 km North West Dhanora Talav 11.27 km North East Sayaji Sarovar 10.84 km South West Karod Nadi 14.51 km North East 6. Reserve Forest Reserve Forest 1.32 km East Gutal Reserve Forest 8.22 km South Reserve Forest 12.30 km South East Reserve Forest 14.76 km South East Reserve Forest 16.12 km South East 7. Vadodara Airport 23.23 km South‐West

1-13

1.2.1.3 MAP OF KEY INFRASTRUCTURE FEATURES AND SETTLEMENTS

A map depicting administrative boundaries up to Taluka level, showing locations of towns

and villages along with National and State highways, major and medium roads and railways

is presented as Figure 1.3. The map also shows the water bodies for better understanding of

project area. The map marks the area within 10 km with the project site as the center.

1-14

FIGURE – 1.3

KEY INFRASTRUCTURE FEATURES AND SETTLEMENTS

1-15

1.3 PURPOSE OF EIA

The EIA study is carried out to assess the pollution potential and evaluate the adequacy and

efficiency of existing and proposed Pollution Control & Environmental Management System.

1.4 OBJECTIVES OF EIA

The main objectives of the study are

1) To assess the background environmental status,

2) To identify potential sources of pollution,

3) To predict and evaluate the impact on environment along with pollution control

measures taken and

4) To prepare a comprehensive Environment Management Plan and Disaster

Management Plan.

1.5 METHODOLOGIES FOR EIA

Taking into consideration proposed expansion project activities and guidelines, an area of 5

km radius from the center of the project has been selected and is designated as the study

area for the purpose of EIA studies.

1.5.1 Base Line Condition

The samples of ambient air, ground and surface water and soil are collected and analyzed as

per the standard methods for establishing the baseline data and to determine the impact of

proposed activity on the same.

1.5.1.1 Ambient Air Environment

The air environment around the plant was studied by setting up eight locations within the

study area of 5 km radius from the project site and collection and monitoring the site

specific meteorological data, viz. wind speed, wind direction, humidity, rainfall and ambient

temperature was carried out. Design of network for ambient air quality monitoring locations

is based on guidelines provided by CPCB. The ambient air samples were collected and

analyzed for SPM, PM10, PM2.5, SO2, NOX, HCl, Cl2, O3, Pb, CO, NH3, C6H6, Benzo (a) Pyrene

(BaP), Arsenic (As), Nickel (Ni) & VOCs for identification, prediction, evaluation and

assessment of potential impact on ambient air environment.

1-16

1.5.1.2 Ground And Surface Water Environment

The water required for domestic and industrial use is being made available from surface

water. Hence, to assess the physico‐chemical quality of the water, a number of water

samples were collected and analyzed for pollution parameters viz., pH, TDS, Turbidity, BOD3,

COD, Fluorides, Chlorides, Sulphates, Nitrates, Ammonical Nitrogen, Hardness, Alkalinity, Oil

& Grease and some heavy metals in order to find out the contamination, if any.

1.5.1.3 Noise Environment

Noise pollution survey was conducted in the study zone. The anticipated noise sources were

industrial activities, which are likely to be increased due to proposed expansion activity.

Noise levels were also recorded in surrounding villages for evaluating general scenario of

the study area. Hourly equivalent sound levels (Leq) were also recorded for calculating Day

and Night noise levels in the surrounding villages.

1.5.1.4 Soil Environment

Soil sampling and analysis was carried out to assess physico‐chemical characteristics of the

soils and delineate existing cropping pattern, existing land use and topography, within the

study area.

1.5.1.5 Biological Environment

Keeping in view, the importance of biological component of total environment due to the

proposed expansion project, biological characterization of terrestrial and aquatic

environments, changes in species diversity of flora and fauna in terrestrial as well as aquatic

systems were studied for impact analysis due to proposed expansion project activity, if any.

1.5.1.6 Socio‐economic Environment

Demographic and related socio‐economic data was collected from census handbook to

assess socio‐economic status of the study area. Assessment of impact on significant

historical, cultural, and archeological sites/places in the area and economic and employment

benefit arisen out from the project is given special attention.

1-17

1.5.2 Identification of Pollution Source

Detailed study of manufacturing process for proposed expansion scenario is carried out

along with input and output of materials, water, and wastewater as well as infrastructure

facilities available.

1.5.3 Evaluation of Pollution Control and Environmental Management System

The qualitative and quantitative analysis of various pollution sources as well as evaluation of

pollution control system is carried out.

1.5.4 Evaluation of Impact

A comprehensive evaluation of environmental impact with reference to proposed expansion

activities is carried out.

1.5.5 Preparation of Environmental Management Plan

A comprehensive Environmental Management Plan has been prepared covering all the

aspects of pollution prevention measures, Air and Water Pollution Control measures,

Hazardous Waste Management, Environmental Surveillance and Environmental

Management Plan.

The present report is an EIA conducted during Post‐Monsoon, 2014 (October, 2014 to

December, 2014). The baseline environmental conditions have been established through

field monitoring and literature survey. The contents of EIA report, details of data collection

and source of secondary data are presented in Figure 1.4.

1.6 STRUCTURE OF REPORT

The objective of the EIA study is preparation of Environment Impact Assessment (EIA) report

based on the guidelines of the Ministry of Environment and Forests (MoEF), CPCB and GPCB.

It incorporates the following.

• Chapter 1 is an Introduction to the Industry, their premises and surrounding areas. It

also expresses the basic objectives and methodologies for EIA studies and work to be

covered under each Environmental component.

1-18

• Chapter 2 presents a Description of Project and Infrastructure facilities including all

industrial and environmental aspects of M/s. Alembic Pharmaceuticals Limited (Unit‐

I) as well as manufacturing process details. This chapter also gives information about

raw material storage and handling, water and wastewater quantitative details, air

pollution and control system, Hazardous Waste generation, storage facility and

disposal and utilities for proposed expansion plant capacity. It also provides

information about proposed Environmental Management Facilities available at the

project site.

• Chapter 3 covers Baseline Environmental Status including meteorological details,

Identification of baseline status of Environmental components of the surrounding

area covering air, water and land environment. Also presents a study of land use

pattern, Biological Environment & Socio‐Economic Environment giving details about

District Panchmahal, Taluka Halol and the study area in terms of land use pattern,

biological environment, and socio‐economic environment.

• Chapter 4 deals with Identification and Prediction of Impacts & Mitigation Measures,

which provides quantification of significant impacts of the proposed expansion

activities of plant on various environmental components. Evaluation of the proposed

pollution control facilities has been presented.

• Chapter 5 deals with Environmental Monitoring Plan

• Chapter 6 describes Additional Studies i.e. Risk assessment and Disaster

management plan that shall be adopted by the company.

• Chapter 7 describes Environment Management Plan (EMP) to be adopted for

mitigation of anticipated adverse impacts if any and to ensure acceptable impacts.

• Chapter 8 describes Executive Summary of the Project.

• Chapter 9 describes Details of Consultants Engaged.

FIGURE 1.4 ____________________________________________________________________________________________________________________ ACTIVITIES, SOURCES OF INFORMATION AND CONTENTS OF EIA REPORT

RECONNAISSANCE SURVEY OF PLANT ANNUAL REPORT MARKET ASSESSMENT PROJECT REPORT

INTRODUCTION

MONITORING OF AIR, WATER & SOIL QUALITY & NOISE LEVELS DATA ON METEOROLOGY, SOCIO‐ECONOMIC STATUS & BASIC AMENITIES SITE VISITS AND INTERVIEWS WITH LOCALS

BASELINE ENVIRONMENTAL

STATUS CENTRAL GROUND WATER BOARD GUJARAT POLLUTION CONTROL BOARD (GPCB) PUBLIC HEALTH ENGINEERING DEPT AGRICULTURE DEPARTMENT FOREST DEPARTMENT IRRIGATION DEPARTMENT EMPLOYMENT EXCHANGE HEALTH CENTER CENSUS OF INDIA INDIAN METEOROLOGICAL DEPT ENVIRONMETAL INFORMATION CENTRE

SOCIOECONOMICSTATUS &

INFRASTRUCTURE

EXISTING & PROPOSED

PLANT

FACILITY DESCRIPTIONIMPACTS METHODOLOGY OF

IMPACT ASSESSMENT

IDENTIFICATION & ASSESSMENT OF IMPACTS EVALUATION OF IMPACTS BY MATRIX METHOD

SOURCE OF INFORMATIONOVERVIEW OF E. I. A. STUDIES ACTIVITIES

ENVIRONMENTAL MANAGEMENT PLAN DESCRIPTION OF EFFLUENT TREATMENT PLAN, AIR

POLLUTION CONTROL, HAZARDOUS WASTE MANAGEMENT, GREEN BELT DEVELOPMENT MONITORING PROGRAM

CONSEQUENCE ANALYSIS PREPARATION OF DISASTER MANAGEMENT PLAN

RISK ASSESSMENTSTUDIES & DISASTER

MANAGEMENT PLAN

SAFETY, HEALTH & ENVIRONMENTAL POLICY GUIDELINES BY DIRECTOR GENERAL OF FACTORY SAFETY, MINISTRY OF LABOR

2-1

CHAPTER ‐ 2

PROJECT DESCRIPTION AND INFRASTRUCTURAL FACILITIES

2.1 BACKGROUND

M/s. Alembic Pharmaceuticals Limited (Unit‐I) proposes expansion of APIs in existing unit at

Survey No. 119, 120 & 121, At & Post: Panelav, Tehsil: Halol, Dist. Panchmahal, Gujarat.

2.2 MANUFACTURING ACTIVITIES

Manufacturing activities in the project include various processes. The activities shall also

include operation of various utilities. The manufacturing process is described in details in

following sections. The list of products and their capacity is given in Table 1.1.

PROCESS DESCRIPTION 1. CLARITHROMYCIN

Manufacturing Process Erythromycin Thiocyanate reacts with liquor ammonia in presence of Methylene dichloride to give erythromycin base. Methylene dichloride layer is separated and washed with water followed by distillation of Methylene dichloride. The residue of erythromycin base reacts with hydroxylamine hydrochloride in presence of Triethyl amine and methanol to give erythromycin Oxime hydrochloride which further reacts with liquor ammonia in Isopropanol to give erythromycin oxime base. Erythromycin oxime base react with 2‐methoxy propane in presence of pyridine hydrobromide followed by reaction with hexamethyl disilazane in methylene dichloride. Reaction mixture is washed with water followed by layer separation of aqueous layer. Methylene dichloride is distilled from reaction mass. The residue further reacts with methyl iodide and potassium hydroxide in presence of toluene and dimethyl sulfoxide. After reaction completion reaction mixture is washed with water. The aqueous layer is separated from reaction mixture; toluene is distilled out from reaction mixture. Residue further reacts with sodium bisulphate in presence of formic acid and ethanol followed by addition of caustic lye to give crude Clarithromycin of 6‐omethyl erythromycin crude. Clarithromycin is recrystallized in ethanol to give Clarithromycin or 6‐o methyl erythromycin.

2-2

Chemical Reaction

2-3

Material Balance

2-4

2-5

2. AZITHROMYCIN

Manufacturing Process Erythromycin thiocyanate reacts with liq‐ammonia in presence of Methylene chloride to give erythromycin base. Methylene chloride is separated and distilled off. Residual erythromycin base react with hydroxyl amine hydrochloride and Triethyl amine in presence of methanol to give erythromycin oxime hydrochloride. Methanol is distilled out and erythromycin oxime hydrochloride reacts with liq‐ammonia in presence of isopropanol to give erythromycin oxime base.

Erythromycin oxime base reacts with sodium bicarbonate and para toluene sulfonyl chloride in presence of methylene chloride to give erythromycin imino ether. Erythromycin imino ether undergoes catalytic reduction in presence of platinum to give aza erythromycin. Aza erythromycin is further methylated with a mixture of formic acid and formaldehyde in acetone to give Azithromycin. Chemical Reaction

2-6

2-7

Material Balance

2-8

2-9

3. ROXYTHROMYCIN Manufacturing Process Erythromycin thiocyanate reacts with liq. Ammonia in presence of methylene chloride to give Erythromycin base. Methylene chloride is separated and distilled off. Residual Erythromycin base reacts with Hydroxyl Amine Hydrochloride and Triethyl Amine in presence of Methanol to give Erythromycin Oxime Hydrochloride. Methanol is distilled out and Erythromycin Oxime Hydrochloride reacts with Liq. Ammonia in presence of Isopropanol to give Erythromycin Oxime Base. Erythromycin Oxime Base reacts with sodium Methoxide and Methoxy ethoxy methylene chloride in presence of acetone to give Roxythromycin Crude. Roxythromycin crude is purified in methanol to give Roxythromycin pure. Chemical Reaction

2-10

Material Balance

2-11

4. VENLAFAXIN HYDROCHLORIDE Manufacturing Process Anisole reacts with Aluminium chloride and acetyl chloride in methylene chloride to give 4‐methoxy acetophene and 4‐methoxy acetophenone reacts with dimethyl formamide, sodium acetate and sulfur to give thioacetamide reacts with Cyclohexanone in presence in presence of grignard reagent to give N,N Dimethyl‐2‐(1‐hydroxy cycloride hexahydrate, in methanol to give N,N Dimethyl‐2‐(1‐hydroxy cyclohexyl)‐2‐(4‐methoxyphenyl)ethyl amine which reacts with Borohydride and nickel chloride hexahydrate, in methanol to give N,N Dimethyl‐2‐(1‐hydroxy cyclohexyl)‐2‐(4‐methoxyphenyl)ethylamine or (+/‐) 1‐(2‐Dimethylamino)‐1‐(4‐methoxyphenyl)ethyl) cyclohexanol, which further crystallized in hydrochloride formation in isopropanol HCL and ethyl acetate as solvent to give final product Venlafaxine hydrochloride. Chemical Reaction

2-12

Material Balance

2-13

5. FENOFIBRATE

Manufacturing Process 4‐Chloro‐4’hydroxy benzophenone is dissolved in acetone and then sodium hydroxide is added. The corresponding sodium phenoxide precipitates and reflux is affected followed by addition of mixture of acetone and chloroform. After reaction completion solvent is distilled from reaction mixture, water is added and acidified. The mother liquor removed from residue by filtration. The residue is dissolved in sodium bicarbonate solution and extracted from ethyl acetate. The aqueous phase is charcolised and filtered. The filtrate is acidified, filtered and dried to get crude fenofibric acid. The crude fenofibric acid is recrystalised in isopropanol and filtered followed by isopropanol washing to get pure fenofibric acid.

The fenofibric acid is esterfied with isopropanol using sulfuric acid as catalyst. After product formation reaction mixture is concentrated by isopropanol distillation up 50 % volume. Reaction mixture filtered and washed with chilled isopropanol. The wet cake material is taken in methylene dichloride, washed with aqueous sodium bicarbonate solution followed by water wash. The organic layer is charcolised, filtered and methylene dichloride distilled to get residue. The residue recrystalised in isopropanol, filters and dried to get fenofibrate. Chemical Reaction

2-14

Material Balance

2-15

2-16

6. IRBESARTAN Manufacturing Process Cyclopentanone is treated with sodium cyanide in the presence of ammonium chloride and ammonia solution to form 1‐aminocyclopentanitrile which is hydrolyzed with hydrochloric acid to get 1‐aminocyclopentanecarboxylic acid hydrochloride which on treatment with Valeroyl chloride in the presence of pyridine forms 1‐valeramido cyclopentanecaboxylic acid. 4’‐bromomethyl‐2‐cyano biphenyl is reacted with phthalimide in the presence of potassium carbonate to form 4’‐phthalamidomethyl ‐2‐ cyanobiphenyl which gives 4’‐aminomethyl‐2‐ cyanobiphenyl by treatment with hydrazine hydrate. valeramido cyclopentanecaboxylic acid and 4’‐aminomethyl‐2‐cyanobiphenyl are condensed and cyclized in the presence of methane sulfonic acid in refluxing toluene to give 2‐(n‐butyl)‐3‐(2’‐cynobiphenyl‐4‐ylmethyl)‐4‐oxo‐1,3‐diazaspiro [4.4] non‐1ene which on treatment with tributyltin chloride and sodium azide in refluxing xylene to form Irbesartan which is isolated and purified in alcohol. Chemical Reaction

2-17

Material Balance

2-18

7. VALSARTAN

Manufacturing Process There are following steps involved in the synthesis of Valsartan. Step ‐ 1: ‐ Preparation of L‐ METHYL VALINATE L‐ Valine is treated with methanol in presence of Thionyl chloride to get L‐ Valine methyl ester which was then neutralized with alkali solution to get L‐methyl valinate. Step ‐ 2: ‐ Preparation of VALSARTAN OXALATE L‐ Methyl valinate is condensed with 4‐ bromo methyl ‐2 ‐ cyano biphenyl in presence of potassium carbonate which was then treated with oxalic acid to isolate the Valsartan oxalate. Step ‐ 3‐A: ‐ Preparation of VALEROYL VALSARTAN The Valsartan oxalate is condensed with Valeroyl chloride in presence of potassium, Carbonate in o‐ xylene to get Valeroyl Valsartan. Step ‐ 3‐B and 3‐C: ‐ Preparation of CRUDE VALSARTAN The cyano group of Valeroyl Valsartan is cyclized in presence of tri butyl tin chloride and sodium azide in o‐xylene at reflux to get methyl Valsartan. The methyl Valsartan is then hydrolyzed with sodium hydroxide and isolated with dichloromethane and cyclohexane to get crude Valsartan. Step ‐ 4:‐ Preparation of VALSARTAN CALCIUM The crude Valsartan is treated with calcium hydroxide in acetone and D I water and filtered to obtained calcium salt of Valsartan. Step ‐ 5‐ Preparation of VALSARTAN Valsartan calcium salt is treated with hydrochloric acid in ethyl acetate and water. The ethyl acetate layer is treated with diisopropyl ether to obtain the pure Valsartan.

2-19

Chemical Reaction

2-20

Material Balance

2-21

8. TELMISARTAN Manufacturing Process 2‐n‐Propyl‐4‐methyl ‐6‐(1‐methyl benzimidazole‐2‐yl) benzimidazole is treated with methyl‐4’‐ (bromomethyl)‐biphenyl‐2‐carboxylate in acetone in the presence of sodium hydroxide to form 4‐[4’‐methyl‐6‐(1‐methyl‐1H‐benzimidazole‐2‐yl‐2‐propyl‐1H‐benzimidazole‐1‐ylmethyl] biphenyl‐2‐carboxylic acid methyl ester which is hydrolyzed with sodium hydroxide in aqueous methanol to give telmisartan which is purified in dichloromethane and methanol. Chemical Reaction

2-22

Material Balance

2-23

9. CLONIDINE HYDROCHLORIDE Manufacturing Process

2,6 Dichloro aniline reacts with Acetic anhydride and formic acid to give N‐(2,6‐dichlorophenyl) formamide, which on reaction with Sulfuryl chloride and Thionyl Chloride gives (2,6‐dichlorophenyl) carbonimidic dichloride, which on insitu reaction with Ethylene Diamine followed by treatment with IPA HCL gives crude Clonidine Hydrochloride. Clonidine Hydrochloride crude on purification with methanol and Isopropanol gives Clonidine hydrochloride API. Chemical Reaction

2-24

Material Balance

2-25

10. MODAFINIL Manufacturing Process Thio Urea and Benzhydrol are reacted in presence of Hydrobromic acid. Then the mass is treated with Ammonia gas and Sulfuric acid. Finally the treatment is done with Acetic Acid and Hydrogen Peroxide to give Modafinil. Chemical Reaction

2-26

Material Balance

2-27

11. LEFLUNOMIDE Manufacturing Process Triethyl Orthoformate & Acetic anhydride are reacted with Ethyl acetate Then the mass is reacted with Hydroxyl amine hydrochloride. Next it is reacted with Glacial Acetic acid, followed by chlorination with Thionyl Chloride. Finally the product is purified in acetone & given carbon treatment. Chemical Reaction

2-28

2-29

2-30

Material Balance

2-31

12. ALENDRONATE SODIUM Manufacturing Process Alendronate sodium is a single step process. This process involves addition of 4 amino butyric Acid Phosphorus Acid, Phosphorous Trichloride in reactor and heating it up to 65 °C and maintaining it for 7 Hours. The completion of the reaction is monitored by HPLC and on completion the reaction is terminated by addition of Toluene and DMW to extract the product in the aqueous layer. After separating and washing the aqueous layer it is given charcoal treatment and filtered and charged back in reactor. The reaction mass is then heated to distill out the excess DMW and then refluxed for 15 hours. After reflux the mass is cooled and the pH of the reaction mass is then adjusted using caustic solution and again treated with charcoal filtered and charged in the reactor and cooled to 25°C and maintained for 4 hours and centrifuged. The solids so obtained are Alendronate Sodium which is dried in a vacuum dryer. Chemical Reaction

2-32

Material Balance

Total input kg.

Starting Material Product output

Alendronat

Quantity Kg.

Output details

200.00 151.80640.00

Solvent

Toluene & Diphenyl Oxide Aq. Effluent

Unreacted product & Salt Water Solid Waste

4.00 6.00

Carbon Hyflo

37.00 Water in drying loss

100.00 20.00 48.00 79.80 60.00

120.00 3.00

40.00 40.00 40.00 80.00 80.00

120.00 4.00

40.00 2.00

100.00 100.00

Diphenyl Oxide 4‐Amino butyric acid Phosphorous acid Phosphorous Trichloride Toluene DM Water Activated charcoal DM Water Toluene DM Water DM Water Caustic soda DM Water Hyflo DM Water Hyflo DM Water Methanol

38.00 Kg

38.00 Alendronate

1076.80 Total 1076.80 Total

2-33

13. O‐DESMETHYLE VENLAFAXINE Manufacturing Process Sodium Hydride, Ethane Thiol are reacted in presence Dimethyl Formamide. The product is finally purified in methanol. Chemical Reaction Material Balance

2-34

14. MEPROBAMATE Manufacturing Process Meprobamate is a single stage process. It involves charging of Liquor ammonia in reactor which is then cooled and to be charged 2‐methyl‐2‐propyl‐1, 3‐propanediol dichlorocarbamate in a period of 120 mins then it is stirred for 30 mins and chilled to 5 °C and maintained for 1 hour. The reaction mass is then filtered in a centrifuge and washed with DMW and unloaded. The wet cake thus obtained is charged in Methanol in reactor heated to 65°C and treated with Charcoal and filtered to reactor. The reaction mass is then chilled up to 10°C and maintained for 60 mins. After maintaining the reaction mass is filtered and wet cake is washed with DMW and unloaded. Methanol purification done another 3‐times.after the wet cake dry the material. Chemical Reaction Material Balance

Total i t

Starting Material Product output b

Quantity Output details

3211.50

Aq. Effluent

Water (CF ML)

0.92 2.00

Carbon Hyflo

38.00 Water in drying loss

311.00 110.00

300.00 60.50

141.00 0.92 2.00

520.00 165.00 444.00

1270.00

Ammonia solution 2‐Methyl‐2‐Propyl‐1,3‐Propa‐ Nediol dichloride Process water Methanol DM Water Activated Charcoal Hyflo DM Water Methanol DM Water

72.00 Kg

72.00 Meprobamate

3324.42 Total 3324.42 Total

2-35

15. VILDAGLIPTIN Manufacturing Process

Stage‐I

Reaction of (2S)‐1‐(chloroacetyl)‐2‐cyanopyrrolidine (KSM‐II) with 3‐Amino‐1‐hydroxy adamantine (KSM‐I) in presence of Potassium Carbonate and Dimethyl Formamide (DMF) as a solvent gives Vildagliptin crude.

Stage‐II Vildagliptin crude is purified by treatment of Aq. Potassium Hydrogen Sulphate and Aq. Potassium Carbonate in presence of Dichloromethane, followed by Acetone crystallization to give Vildagliptin API. Chemical Reaction

2-36

Material Balance

2-37

16. RIVASTIGMINE TARTRATE Manufacturing Process Stage‐I (Rivastigmine Tartrate Crude) Carbamoylation of (S)‐3‐(1‐dimethyl amino ethyl) phenol carried out with N‐ethyl‐N‐methyl Carbamoyl chloride in Toluene using Triethylamine as base and 4‐dimethyl amino pyridine as catalyst at 60‐65°C. After completion of reaction cool reaction mass to 25‐35°C, filter the reaction mass, wash the solid salt with Toluene. Charge water in to the filtrate, stir and separate layers. Wash the organic layer with Sodium bicarbonate solution, Hydrochloric acid solution and then water and than charcoalized with activated charcoal. Distill out toluene from filtrate to obtain Rivastigmine Base. Charge Denature spirit and L (+) tartaric acid in Rivastigmine Base, and heat to 55‐60°C to get clear solution and than charge Ethyl acetate, Cool to 40°C and seed the reaction mass with Rivastigmine Tartrate, cool to 0‐5°C and stir for 4‐5 hours, filter, Wash with Ethyl acetate and dry the crude Rivastigmine Tartrate at 40‐50°C in vacuum oven.

Stage‐II (Rivastigmine Tartrate) Dissolve Rivastigmine Tartrate in Ethyl Alcohol, heat to 55‐60°C to get clear solution, charcoalized and distill out Ethyl Alcohol. Charge Ethyl Alcohol , heat to 55‐60°C and than charge Ethyl acetate, Cool to 40°C and seed the reaction mass with Rivastigmine Tartrate, cool to 0‐5°C and stir for 4‐5 hours, filter, Wash with Ethyl acetate and dry the Rivastigmine Tartrate at 40‐50°C in vacuum oven till constant weight. Chemical Reaction

2-38

Material Balance

2-39

17. TOPIRAMATE Manufacturing Process D‐Fructose is reacted with Sulphuric Acid in presence of Acetone. The isolation / purification are done in Cyclohexane / IPA. Then the mass is reacted with Sulfuryl Chloride in presence of MDC and then with Pyridine in presence of Citric Acid. Next the mass is reacted with ammonia gas in MDC and acetic Acid. Final purification of the product is done in methanol. Chemical Reaction

2-40

Material Balance Stage ‐ 1

Raw Material In Put Quantity Kgs

Product Out Put Quantity Kgs

Out Put Details

1525.0 3105.2100.0 1507.836.5 801.654.5 69.82900.0 92.540.0 20.0 80.0

Aqueous spent Spent MDC Distilled THF Loss during drying Output

755.7 25.0 14.0

MDC Fructopyranose Pyridine Sulfuryl chloride Process water Citric acid Sodium bicarbonate Sodium chloride THF Ammonia gas Sodium Hydroxide Acetic acid 26.2

92.5

Total 5576.9 5576.9

Stage – 2



Out Put Details

411.3 3.680.0 1371.31.6 10.42.0 69.6960.0

Methanol Topiramate (Stage‐I) Activated carbon Hyflo DM water Total 1454.9

69.6

1454.9

Spent carbon+ Hyflo Spent Methanol Loss during drying Output

2-41

18. LACOSAMIDE Manufacturing Process Stage‐I: Preparation of (2R)‐2‐[(tert‐butoxycarbonyl)amino]‐3‐hydroxypropanoic acid from (2R)‐2‐amino‐3‐hydroxypropanoic acid (D‐Serine) (2R)‐2‐amino‐3‐hydroxypropanoic acid (D‐Serine) is react with di‐tertiary‐butyl‐di‐carbonate in presence of base using process water as a solvent gives (2R)‐2‐[(tert‐butoxycarbonyl)amino]‐3‐hydroxypropanoic acid. Stage‐II: Preparation of tert‐butyl[(2R)‐1‐(benzylamino)‐3‐hydroxy‐1‐oxopropan‐2‐yl]carbamate from (2R)‐2‐[(tert‐butoxycarbonyl)amino]‐3‐hydroxypropanoic acid (Stage‐I) (2R)‐2‐[(tert‐butoxycarbonyl)amino]‐3‐hydroxypropanoic acid (Stage‐I) is react with methyl chloroformate in presence of N‐methyl morpholine followed by reaction with benzyl amine using MDC as solvent to give tert ‐butyl[(2R)‐1‐(benzylamino)‐3‐hydroxy‐1‐oxopropan‐2‐yl]carbamate. Stage‐III: Preparation of tert‐butyl[(2R)‐1‐(benzylamino)‐3‐methoxy‐1‐oxopropan‐2‐yl]carbamate from tert‐butyl[(2R)‐1‐(benzylamino)‐3‐hydroxy‐1‐oxopropan‐2‐yl]carbamate (Stage‐II) tert‐butyl[(2R)‐1‐(benzylamino)‐3‐hydroxy‐1‐oxopropan‐2‐yl]carbamate (Stage‐II) is react with dimethyl sulfate in presence of tetrabutyl ammonium bromide and sodium hydroxide as a base in Toluene solvent and process water as a solvent to give tert‐butyl[(2R)‐1‐(benzylamino)‐3‐methoxy‐1‐oxopropan‐2‐yl]carbamate. Stage‐III: Preparation of (2R)‐2‐(acetylamino)‐N‐benzyl‐3‐methoxypropanamide from tert‐butyl[(2R)‐1‐(benzylamino)‐3‐methoxy‐1‐oxopropan‐2‐yl]carbamate (Stage‐III) tert‐butyl[(2R)‐1‐(benzylamino)‐3‐methoxy‐1‐oxopropan‐2‐yl]carbamate (Stage‐III) is react with concentrated Hydrochloric acid in MDC as a solvent to give (2R)‐2‐amino‐N‐benzyl‐3‐methoxypropanamide which is further reacts with acetic anhydride then isolation with isopropyl alcohol and n‐Heptane to yield (2R)‐2‐(acetylamino)‐N‐benzyl‐3‐methoxypropanamide.

2-42

Chemical Reaction

2-43


RAW MATERIAL INPUT QUANTITY‐

OUTPUT QUANTITY OUTPUT DETAILS

DM Water 2475.00 200.00 Liberation of CO2 gasSodium Hydroxide 169.60 225.00 Salt D‐Serine 165.00 3232.00 Aqueous layerDi‐tert.Butyl dicarbonate 548.22 1266.50 Distilled Ethyl AcetateEthyl Acetate 1336.50 70.00 Evaporation lossPotassium Hydrogen Sulphate

660.00 142.73

Distilled Toluene

Toluene 1427.25 1350.00 Toluene ML Stage‐I seeding 1.65 50.00 Toluene condensate

247.00 Dry output Total 6783.22 6783.22

Stage ‐ 2

RAW MATERIAL INPUT QUANTITY


Benzylamine 130.0 1007.50 Aqueous layer MDC 2650.0 850.00 Aqueous layer Stage‐1 250.0 3250.00 Aqueous layer N‐Methyl Morpholine 135.0 2520.00 Distilled MDC Methylchloroformate 127.5 145.00 Evaporation lossDMWater 4750.0 210.00 Distilled Ethyl AcetatePotassium Hydrogen sulphide 75.0 1618.00 Cyclohexane MLEthyl Acetate 225.0 50.00 Cyclohexane condensateCyclohexane 1558.0 250.00 Dry output

Total 9900.50 9900.50

Stage ‐ 3



Toluene 870.00 1300.35 Aqueous layerStage‐2 150.00 820.41 Distill TolueneCyclohexane 600.00 116.69 Evaporation lossSodium hydroxide solution 355.95 144.90 Distill CyclohexaneSodium bicarbonate solution 787.50 405.00 Cyclohexane MLTetra butyl ammonium 27.90 133.00 Dry output Di methyl sulfate 129.00

Total 2920.35 2920.35

2-44

Stage ‐ 4

RAW MATERIAL INPUT QUANTITY‐KG


MDC 2819.60 891.13 Organic LayerStage‐3 133.00 2550.25 Aqueous LayerHydrochloric Acid 226.10 13.65 Spent activated charcoalDM water 2128.00 1788.48 Distilled MDC Sodium Hydroxide 79.80 225.00 Evaporation LossSodium Chloride 59.85 288.22 Distilled IPA Acetic Anhydride 53.20 1005.47 N‐Heptane MLSodium Bicarbonate 13.30 82.00 Dry output Activated Charcoal 6.65 IPA 313.22 N‐Heptane 1009.47 Hyflow 2.00

Total 6844.19 6844.19

2-45

19. PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE Manufacturing Process

Stage‐I

6(S)‐4, 5, 6, 7‐tetrahydro‐1, 3‐benzothiazole‐2, 6‐dimine react with Propionaldehyde and sodium Borohydride in presence of methanol. Then Methanol distilled out completely and product is extracted in Ethyl Acetate. Ethyl Acetate is completely distilled out and then crude Pramipexole Dihydrochloride Monohydrate stage‐I purified with Acetonitrile.

Stage‐II Pramipexole Stage‐I is dissolved in ethanol and charcoalized with Activated Charcoal. Reaction mass then filtered through hyflo bed. pH of the reaction mass adjusted with Ethanolic HCL and maintained for crystallization. Reaction mass is then filtered to get wet cake and this wet cake is dried to get Pramipexole Dihydrochloride Monohydrate Stage‐II.

Stage‐III Pramipexole Dihydrochloride Monohydrate Stage‐II is purified in ethanol to get Pramipexole Dihydrochloride Monohydrate API. Chemical Reaction

2-46

Material Balance

2-47

20. OLMESARTAN MEDOXOMIL

Manufacturing Process Trityl Olmesartan Medoxomil dissolved in Dichloromethane and Methanol and reacted with Methanolic HCL. Washed the organic layer with Sodium Bicarbonate solution and DM Water. Dichloromethane distilled out completely and crystallized in Ethyl Acetate gives Olmesartan Medoxomil Stage‐III.

Charcoal treatment given to Olmesartan Medoxomil Stage‐III after dissolving in Acetone. Reaction mass filtered through hyflo bed and washed with Acetone. Then Acetone is distilled out partially and remaining reaction mass filtered. Wet cake washed with Acetone and the wet cake dried to get Olmesartan Medoxomil API. Chemical Reaction

2-48

2-49

Material Balance

2-50

21. LINEZOLID Manufacturing Process Stage I ‐preparation of stage I: ‐ KSM react with sodium azide in DMF at 60‐65°Cafter water add the stage I Preparation of stage II‐The reaction of stage I with hydrogen gas over 10% Pd/c in acetate at 15‐20°C affords the stage II insitu which is acetylated in acetone with acetic anhydride triethyl amine at 0‐5°gives crude stage II which is then heated in toluene gives pure Linezolid. Chemical Reaction

2-51




Dimethyl Formamide (R)‐[N‐3‐(3‐fluoro‐4‐ morpholinyphenyl)‐2‐oxo‐5‐ oxazolidinyl] methyl methane

198.00 666.80 Centrifuge ML

Sulfonate 65.00 15.00 Drying Loss Sodium Azide 15.80 52.00 Linezolid Stage 1Process Water 455.00

Total 733.80 733.80

Stage ‐ 2

RAW MATERIAL INPUT QUANTITY


Process water 2200.00 2300.00Water Palladium on carbon 3.00 200.00Spent MethanolMethanol 200.00 36.00Hydrogen gas ventEthyl Acetate 1665.00 28.00Nitrogen gas ventStage‐1 45.00 1640.00Distill Ethyl acetateHydrogen gas 36.00 200.00Acetone Nitrogen gas 28.00 2.00Hyflo Acetic anhydride 14.90 0.90Activated charcoalTriethyl amine 19.85 225.00Distill Acetone Activated charcoal 0.90 599.75Centrifuge ML (Acetone)Acetone 965.00 90.00Centrifuge ML (Water)Hyflo 2.00 290.00Centrifuge ML (Toluene)DM water 190.00 15.00Drying loss Toluene 290.00 3.00Palladium on carbon 30.00Linezolid Total 5659.65 5659.65

2-52

22. LERCANIDIPINE HYDROCHLORIDE

Manufacturing Process Stage‐I 1,4‐Dihydro‐2,6‐dimethyl‐4‐(3‐nitrophenyl)‐3;5‐pyridine dicarboxylic acid (L‐Acid) condensation with 1‐[(3,3‐diphenylpropyl)(methyl)amino]‐2‐methylpropan‐2‐ol(L‐Alcohol) using DCC, DMAP, toluene, Reaction completed then add water and mass is centrifuged wash with Toluene , Filtrate ML taken for layer separation then distilled out Toluene and mass dissolve in Ethyl Acetate and given 1N HCl wash. Ethyl Acetate to be distilled out and the precipitated mass is centrifuged, washed with Ethyl Acetate & dried to get Lercanidipine Hydrochloride Crude.

Stage‐II

Crude Lercanidipine Hydrochloride dissolved in Ethanol and charcoalized the reaction mass then cooled and precipitated. The precipitated mass is centrifuged, washed with Ethanol & dried to get Ist pure Lercanidipine Hydrochloride.

Stage‐III Ist pure Lercanidipine Hydrochloride dissolved in Ethyl Acetate and wash with Sodium Carbonate solution, wash with 1N HCl solution, Ethyl Acetate distilled and precipitated mass is centrifuged, washed with Ethyl Acetate & dried to get Lercanidipine Hydrochloride API. Chemical Reaction

2-53

2-54

Material Balance

2-55

23. FLUXETINE HYDROCHLORIDE

Manufacturing Process

Stage‐I 3‐Chloro‐1‐phenyl propanol reacts with aqueous Monomethylamine to give 3‐(Methylamine)‐1‐ phenylpropan‐1‐ol.

Stage‐II (Fluoxetine Hydrochloride Crude) 3‐(Methylamine)‐1‐phenylpropan‐1‐ol reacts with 4‐Chlorobenzotrifluoride gives Fluoxetine base which is converted into its salts by using Ethyl Acetate Hydrochloride solution gives Fluoxetine Hydrochloride Crude.

Stage‐III (Fluoxetine Hydrochloride API) Purification of crude Fluoxetine Hydrochloride in Toluene and DM Water furnished the pure Fluoxetine Hydrochloride.

2-56

Chemical Reaction Material Balance

2-57

2-58

24. DEFERASIROX Manufacturing Process Salicylic acid is converted into Salicyloyl Chloride and salicyloyl chloride is converted to Sta presence of salicyliamide & O‐Xylene. After completion of reaction, reaction mass content vacuum to gives crude stage I which on purification with methanol followed by filtration give stage I on reacting with 4‐Hydrazino benzoic acid in presence of ethanol & potassium hy gives crude which on purification with DMF & 30% Hydrogen peroxide yield crude Defera Crude Deferasirox dissolve in mixture of ethyl acetate & methanol. Water is added to it soli concentration of reaction mass. Chemical Reaction

2-59

2-60

Material Balance

Total Input Material Product Output Total Output Material

340.00 O‐Xylene 26.90 Liberation of SO2 gas

1.70 N,N‐Dimethyl Formamide

170.00 Distill o‐Xylene

85.00 Salicylic acid 587.61 Centrifuge ML(Methanol)

66.90 Thionyl chloride 15.00 Drying loss

75.91 Salicylamide 80.00 Deferasirox Stage‐1

310.00 Methanol

879.51 Total

Deferasirox

Stage‐1

80.00 kg

879.51 Total

Material Product Output

Total Output

Material

10.00 Ethanol 11.85 Centrifuge ML(Ethanol)

46.00 Process water 34.40 Centrifuge ML(Water)

1.00 Stage‐1 21.00 (N,N‐Dimethyl formamide)

0.70 4‐Hydrazino benzoic acid 1.50 Drying loss

0.15 Potassium hydrogen sulphate

1.10 Deferasirox Stage‐2

10.00 N,N‐Dimethyl Formamide

2.00 Hydrogen peroxide

69.85 Total

Deferasirox

Stage‐2

1.10 kg

69.85 Total

2-61

Total Input Material Product Output Total Output Material

530.00 Methanol 200.00 Methanol

330.00 Ethyl acetate 2.00 Hyflo Distill mix solvent(Methanol +Ethyl Acetate +DM Water)

30.00 Stage‐2 470.00 Centrifuge ML(mix solvent)

2.00 Hyflo 15.00 Drying loss

360.00 DM water 27.00 Deferasirox

1252.00 Total

Deferasirox

27.00 kg

1252.00 Total

2-62

25. ROPINIROLE HYDROCHLORIDE Manufacturing Process 2‐Methyl ‐3 nitro phenyl ethyl ‐N,N‐di‐n‐propyl ammonium oxalate undergoes reaction with in presence of potassium ethoide and form Ethyl 2‐nitro‐6‐(N,N‐di‐n‐propylaminoethyl) Ph pyruate,Ester hydrolysis and decarboxylation of Ethyl 2‐nitro‐6‐(N,N‐di‐n‐propylaminoethy in presence of Sodium hydroxide and 30%hydrogen peroxidegives [2‐nitro‐6‐(N,N‐di‐n‐prethyl)Phenyl]acetic acid hydeochloride .Reduction and insitu cyclization of [2‐Nitro‐6‐(2‐(Npropylamino)ethyl )phenyl]acetic acid HCL in presence of 10%palladium on caron using D solvent givesRopinirole HCL tech. Acid Base purification of ropinirole HCL tech using ethylacetate/sodiumbicarbonate/ethanolic HCL gives Ropinirole Hydrochloride. Chemical Reaction

2-63

2-64




Out Put Details

Process water 2070.00 34.00 kg 1341.92 Aqueous layer

Sodium Hydroxide 60.12 15.00 Salt Centrifuge ML

Methyl‐3‐ Nitrophenylethyl‐ N,N‐di‐n‐Propyl Ammonium oxalate

60.00 86.00 (Ethyl acetate)

Ethyl Acetate 1110.00 750.00 Distill Ethyl acetate

Sodium Sulphate 15.00 265.00 Distill THF

Tetrahydrofuran 320.00 55.00 Evaporation loss

Potassium Ethoxide 15.68 180.00 Organic Layer

Diethyl oxalate 29.72 1239.60 Centrifuge ML(Water)

Hydrochloric acid 132.00 50.00 Water

Hydrogen peroxide 24.00 720.00 Distill Ethanol

Sodium Chloride 180.00 316.00 Centrifuge ML

Ethanol 1040.00 10.00 Drying loss

Acetonitrile 6.00 34.00 Ropinorole Hydrochloride Stage‐1

Total 5062.52 5062.52 Stage – 2

Raw Material In Put Quantity

Kgs


Out Put Details

Process Water 1808.00 36.00 Hydrogen gas vent Stage‐1 30.00 22.50 Nitrogen gas vent Palladium on Charcoal (50% wet)

12.00 12.00 Spent Palladium on Charcoal

Hydrogen gas 36.00 200.00 Water Nitrogen gas 22.50 1.50 Activated Charcoal Activated Charcoal 1.50 1.50 Hyflo Sodium dithionite 1.50 1662.90 Aqueous layer Hyflo 1.50 570.00 Distill Ethyl acetate Sodium carbonate 11.40 280.00 Centrifuge ML Ethyl Acetate 600.00 10.00 Drying loss Ethanol 270.00 19.00 Ropinorole hydrochloride

Stage‐2 Ethanolic HCL 21.00

Total 2815.40

Ropinorole hydrochloride Stage‐2 19.00 Kg

2815.40 Total

2-65

Stage – 3 Raw Material In Put

Quantity Kgs


Out Put Details

DM Water 644.00 200.00 DM Water Stage‐2 21.00 4.00 Hyflo Activated Charcoal 1.50 1.05 Activated Charcoal

Sodium dithionite 1.50 457.40 Aqueous layer Hyflo 4.00 200.00 Ethyl acetate Ethyl Acetate 908.00 456.00 Distill Ethyl acetate Sodium carbonate 7.35 312.00 Centrifuge ML Ethanol 42.00 5.00 Drying loss Ethanolic HCL 23.10 17.00 Ropinorole hydrochloride

Total 1652.45

Ropinorole hydrochloride 17.00 Kg

1652.45 Total

2-66

26. HYDROCHLOROTHIAZIDE Manufacturing Process Stage‐I: Preparation of Hydrochlorothiazide Crude 4‐Amino‐6‐chloro‐1,3‐benzenedisulfonamide (CBD) is heated with Para formaldehyde at 95‐100°C in water for 2‐4 hours to give crude Hydrochlorothiazide. Stage‐I: Purification of Hydrochlorothiazide Crude Purification of Hydrochlorothiazide crude is carried out in a mixture of diluted Ammonia and caustic lye solution followed by pH adjustment to give pure Hydrochlorothiazide. Chemical Reaction

2-67

Material Balance Stage ‐ 1 Raw Material In Put Quantity

Kgs Product Out Put Quantity

KgsOut Put Details

3420.0 3431.6 180.0 18920.8

Aqueous Effluent Output

D M water CBD Para formaldehyde

189

Total 3621 3621 Stage – 2

In Put Quantity Kgs


15.0 5.0150.0 2189.4

1490.0 99.4

Out Put Details Spent carbon Aqueous Effluent loss during drying

333.8 135.0 Output3.0 2.0

Raw Material Sodium Hydroxide Hydrochlorothiazide Stage‐I DM Water Ammonia solution Activated Charcoal Hyflo Hydrochloric Acid 435.0

135

Total 2428.8 2428.8

2-68

27. LAMOTRIGINE Manufacturing Process Amino Guanidine bicarbonate is reacted 2,3 DBN & then purified in n‐Propanol. Chemical Reaction

2-69




Out Put Details

4113.09326.02512.5

15359.8Aqueous Effluent Process water Process water for cake wash Sulphuric Acid 256.3 752.0Aqueous WashDichloro Benzoyl Nitrile 250.0 115water loss in dryingAcetonitrile 4.0 235Output

235

Total 16461.8 16461.8

Stage ‐ 2



Out Put Details

1026.2 6.1

3.1 1026.262.0 8.06

Spent carbon + HyflowDilute n‐Propanol vapor loss on Drying

n‐Propanol Activated carbon Lamotrigine (Stage‐I) Hyflo 3.0 53.94 Output

53.94

Total 1094.3 1094.3

Stage ‐ 3



Out Put Details

n‐Propanol 5192.1 21.8 Spent carbon + HyflowActivated carbon 18.8 5192.1 Dilute n‐PropanolLamotrigine (Stage‐I) 375.0 48.75 vapor loss on DryingHyflo 3.0 326.25 Output

Total 5588.8 5588.8

2-70

28. METOPROLOL TARTRATE Manufacturing Process NaOH is added to a hot solution of 4‐(2‐methoxyethyl) phenol and Epichlorohydrine and stirred for 2.5 hour to give epoxy compound which on reacting with Mono isopropyl amine in water to give Metoprolol Base. After addition of L‐(+)‐Tartaric acid to a solution of Metoprolol Base in Acetone gives Metoprolol Tartrate. Chemical Reaction

2-71




Out Put Details

Methanol 1676.8 39.5 Methanol lossHy. HCl 355.9 316 Spent MethanolSodium Carbonate 115.4 5480.365 Aqueous EffluentErythromycin 'A' 600.0 335 Aqueous WashProcess water 2878.8 262.48 water loss in dryingProcess water for cake 871.2Process water for cake 340.9 405.6 Out Put

405.6

Total 6838.9 6838.9 Stage ‐ 2

In Put Quantity Kgs


2991.6 293175.0 4.65

3.8 75

Out Put Details Spent Acetone ML Solid Waste

20.0 81.75 Out Put

Raw Material Acetone MTT (Stage‐I) Activated carbon Tartaric acid Hyflo 2.0

81.75

Total 3092.4 3092.4

2-72

29. METOPROLOL SUCCINATE Manufacturing Process Sodium Hydroxide is added to a hot solution of 4‐(2‐methoxyethyl) phenol and Epichlorohydrine and stirred for 2.5 hour to give Epoxy compound which on reacting with Mono isopropyl amine in water to give Metoprolol Base. After addition of Succinic acid to a solution of Metoprolol Base in Acetone give Metoprolol Succinate. Chemical Reaction

2-73




4918.3 11.3 185.0 4918.3

9.3 38.9

Out Put Details Spent carbon+ Hyflo Acetone CF ML Loss during drying

38.8 185.0 Output

Acetone Metoprolol Tartrate Stage‐I Activated carbon Succinic Acid Hyflo 2.0

185

Total 5153 5153

2-74

30. QUETIAPINE FUMARATE Manufacturing Process Stage‐I: Formation of Quetiapine Fumarate Crude Dibenzo[b,f][1,4]Tiazepine‐11(10H)‐one (DBT) is reacted with Phosphorous Oxychloride in presence of N,N‐Dimethyl Aniline (DMA) as a base in Toluene at 110‐115°C to give residue of 11‐Chlorodibenzo[b,f][1,4]Thiazepine (Stage‐Ia). 11‐Chlorodibenzo[b,f][1,4]Thiazepine (Stage‐Ia) is reacted with 1‐[2‐(2‐hydroxyethoxy)ethyl] Piperazine [HEEP] in a mixture of Toluene/ water at 95‐105°C temperature to give viscous oil of Quetiapine Fumarate (Stage‐Ib). Quetiapine Fumarate Crude (Stage‐I) is formed by reacting with Fumaric acid in Methanol. Stage‐II: Formation of Quetiapine Fumarate Quetiapine Fumarate Crude (Stage‐I) is Purified from Methanol/ Water at 60‐65°C.

2-75

Chemical Reaction

2-76

Material Balance

2-77

31. PENTOSAN POLYSULPHATE SODIUM Manufacturing Process Stage I: ‐ Preparation of sodium salt of sulfuric acid ester of Xylan‐ Xylan is esterified with chloro sulfonic a pyridine to give sulfuric acid ester of Xylan, which is isolated as sodium salt of sulfuric acid of Xylan by trihydroxide in methanol. Stage II:‐ Prep Pentosan Polysulfate Sodium:‐ Sodium salt of sulfuric acid ester of Xylan is subjected to oxidative depolym of hydrogen peroxide and sulfuric acid gives crude Pentosan Polysulfate Sodium. Pentosan Polysulfate sodium (crude) is purified by reverse osmosis to yield pure pentosan Polysulfate sod by crystallization from methanol Chemical Reaction

2-78

2-79

Material Balance

2-80

2-81

32. LEVETIRACETAM Manufacturing Process Stage‐I S(+)‐2‐amino butyramide Hydrochloride reacts with 4‐chloro Butyryl chloride in presence of Tetra butyl ammonium bromide, potassium hydroxide to give the Levetiracetam crude (Stage‐I). Stage‐II Levetiracetam crude is purified by charcoal treatment with Dichloromethane solvent. Then Dichloromethane is completely distilled out and finally crystallized in Ethyl Acetate to give the Levetiracetam API. Chemical Reaction

2-82

Material Balance

2-83

33. FAMOTIDINE Manufacturing Process

Stage‐I This stage involves the condensation reaction between ITU and IF in presence of NaOH, Methanol and Water to give Famotidine Technical, which is leached with methanol to get Famotidine Crude.

Stage‐II Famotidine Crude in presence of Methanol, Water, Acetic Acid and Ammonia Solution forms Famotidine API. Chemical Reaction

2-84

Material Balance

2-85

34. MEMANTINE HYDROCHLORIDE Manufacturing Process 1‐bromo‐3,5 dimethyladmantane is react with Aceto nitrile and sulfuric acid gives 1‐acetamido‐3,5dimethyl admantane which upon reaction with sodium hydroxidein presence of PEG‐400 gives Memantine base . BY addition of Conc HCl in memantine base gives memantine Hydrochloride crude and which upon purification gives Memantine HCL Material Balance Stage ‐ 1

Total input Starting Material Product output Quantity Output details

kg. Memantine hydrochloride Stage‐1 Kg.

58.00

85.00 1‐Bromo‐3, 5‐ Dimethyladamantane Kg. 2172.60 Aqueous Layer

85.00 Acetonitrile 437.50 Distill Toluene

170.00 Sulphuric Acid 224.75 Centrifuge ML(Toluene)

1912.50 Process water 15.00 Drying loss

650.25 Toluene

0.85 Sodium Hydrosulfite

4.25 Sodium bicaronate 58.00

Memantine hydrochloride Stage‐1

2907.85 Total 2907.85 Total

2-86

2-87

2-88

35. PREGABALIN Manufacturing Process Sodium Hydroxide solution in Process water is chilled at 0‐10°C and then charge R‐(‐)‐3‐(Carbamoylmethyl)‐5‐methylhexanoic acid [R‐(‐)‐CMH]. Addition of liquid Bromine is done at 0‐5°C then raise the temperature of the reaction mass up to 30‐35°C. After reaction monitoring, raise the temperature of the reaction mass to 55‐60°C and apply carbon treatment. The clear filtrate is then received in another reactor. Excess water is distilled off from the reaction mass. The reaction mixture is acidified with concentrated Hydrochloric acid. Reaction mass is then up to 80‐85°C and after that gradual cooling to 25‐30°C. The material is centrifuged after maintaining of the reaction mass at 25‐30°C for 4‐6 hrs. The dry material is then charged in IPA and raises the temperature to 80‐85°C. Add DM water to reaction mass at 80‐85°C. Filter the clear reaction mass and chill it to 8‐12°C. The material is then centrifuged and dried in under vacuum. Chemical Reaction

2-89

Material Balance Stage ‐ 1 Raw Material In Put Quantity

Kgs Product Out Put Quantity

Kgs Out Put Details

Process water 2590.0 28.0 Spent carbon and hyflo Sodium Hydroxide 347.2 3623.7 Spent ML 4‐CMH 250.0 62.5 Loss on drying Liquid Bromine 224.0 162.5 Out Put Activated carbon 12.5 Hyflo 3.0 Hydrochloric acid 450.0

162.5

Total 3877 3877

Stage ‐ 2



Out Put Details

Pregabalin (Stage‐I) 215.0 2150.0 Spent ML IPA 1290.0 32.2 Loss on drying DM water 860.0 182.8 Out Put

182.8

Total 2365 2365

2-90

36. IVABRADINE Manufacturing Process

Stage‐I: Preparation of 3‐(3‐chloropropyl)‐7,8‐dimethoxy‐1,3‐dihydro‐2H‐benzazepin‐2‐one

(Unreduced chloro).

1, 3‐dihydro‐7, 8‐dimethoxy‐2H‐3‐benzazepin‐2‐one (KSM‐I) is reacted with 1‐bromo‐3‐chloro

propane in presence of Potassium tert Butoxide in Dimethyl sulfoxide to gives 3‐(3‐

chloropropyl)‐7,8‐dimethoxy‐1,3‐dihydro‐2H‐3‐benzazepin‐2‐one (Unreduced chloro).

Stage‐II: Preparation of 3‐(3‐chloropropyl)‐7,8‐dimethoxy‐1,3,4,5‐ tetrahydro‐2H‐3‐

benzazepin‐2‐one ( Reduced chloro)

Catalytic Hydrogenation of stage‐I in Denatured alcohol with cyclohexane using pd/C gives 3‐(3‐

chloropropyl)‐7,8‐dimethoxy‐1,3,4,5‐tetrahydro‐2H‐3‐benzazepin‐2‐one ( Reduced chloro).

Stage‐III: Preparation of Ivabradine Hydrochloride Crude 3‐(3‐chloropropyl)‐7,8‐dimethoxy‐1,3,4,5‐tetrahydro‐2H‐3‐benzazepin‐2‐one (stage‐II) is

reacted with (7S)‐3,4‐dimethoxy‐N‐methyl‐bicyclo[4.2.0]octa‐1,3,5‐trien‐7‐methanamine

Hydrochloride (KSM‐II)in presence of potassium carbonate and Sodium iodide in acetone to

gives Ivabradine Hydrochloride Crude.

Stage‐IV: Preparation of Ivabradine Hydrochloride (API).

Ivabradine Hydrochloride recrystallised using methanol and acetone.

2-91

Br Cl N

H3CO

H3CO

O

Cl

t - BuOK,DMSO

NH

H3CO

H3CO

O

KSM - I stage - I

MW 219.23 295.76

M F C12H13NO3 C15H18ClNO3

1 - bromo - 3 - chloro propane

157.43

C3H6BrCl

CAS No. 73942 - 87 - 7 109 - 70 -6 85175 - 59 - 3

N

H3CO

H3CO

O

Cl

N

H3CO

H3CO

O

Cl

Pd/C , Denature alcohol

H2

295.76

stage - I

297.77

stage - II

M W

M F C15H18ClNO3 C15H20ClNO3

CAS No. 85175 - 59 -3 85175 - 65 - 1

N

H3CO

H3CO

O

Cl

297.77

(stage - II)

N

H3CO

H3CO

O

N

OCH3

OCH3

CH3

K2CO3, Acetone

NaI HCl

505.05

(stage - III)

NH

OCH3

OCH3

CH3

HCl+

243.73

(KSM - II)

M W

M F C15H20ClNO3 C12H17NO2. HClC27H36N2O5.HCl

CAS No. 148849 - 67- 6866783 - 13 - 385175 - 65 1

Chemical Reaction Stage I

Stage II

Stage III Stage IV

2-92

Mass Balance Total input

Kgs. Starting Material

Product output IVABRADINE I

Quantity Kgs.

Output details

0.947

1,3‐Dihydro‐7,8‐dimethoxy‐2H‐3,3 Benzazapin 1.374 Aq. Effluent

0.533 Potassium tert Butoxide 0.009 Evaporation loss

1.020 1‐Bromo‐3‐Chloro propane

2.501 Total

1.118kgs

1.383 Total

Total input


Product output IVABRADINE II

Quantity Kgs.

Output details

1.188 Stage I 0.760 Aq. Effluent 0.475 Hydrogen Gas 0.119 Evaporation loss

1.663 Total

0.784kgs 0.879 Total

Total input


Product output IVABRADINE III

Quantity Kgs.

Output details

0.784 Stage II 0.619 Aq. Effluent 0.321 KSM II 0.282 Evaporation loss 0.549 Potassium Carbonate 0.118 Carbon Dioxide 0.102 sodium Iodide 0.604 Hydrochloric Acid

2.360 Total



IVABRADINE Quantity

Kgs. Output details

1.333 Stage III 0.280 Aq. Effluent 0.053 Evaporation loss

1.333 Total


2-93

37. AZILSARTAN Manufacturing Process Stage‐I: Methyl 2‐ethoxy‐1‐[[2’‐(hydroxyamidino)biphenyl‐4‐yl]methyl]‐1H‐benzimidazole‐7‐

carboxylate. Methyl 1‐[(2’‐cyanobiphenyl‐4‐yl)methyl] ‐2‐ethoxy‐1H‐benzimidazole‐7‐

carboxylate is reacted with hydroxylamine hydrochloride, sodium carbonate in presence of

DMSO and heated to give stage‐I after pouring in process water. Stage‐I is purified by dissolving

in mixture of MDC and aqueous HCl. Pure stage‐I is precipitated by adding aqueous sodium

hydroxide

Stage‐II: Methyl 1‐[[2'‐(2,5‐dihydro‐5‐oxo‐4H‐1,2,4‐oxadiazol‐3‐yl)biphenyl‐4‐yl]methyl]‐ 2‐

ethoxy‐1H‐benzimidazole‐7‐carboxylate. Stage‐I is reacted with ethylchloroformate in presence

of potassium carbonateand MDC as a solvent gives stage‐II (in‐situ). It is further cyclized using

O‐Xylene to give stage‐II.

Stage‐III: 1‐[[2'‐(2,5‐dihydro‐5‐oxo‐4H‐1,2,4‐oxadiazol‐3‐yl)biphenyl‐4‐yl]methyl]‐ 2‐ethoxy‐1H‐

benzimidazole‐7‐carboxylic acid Stage‐II is hydrolyzed by sodium hydroxide in presence of THF

and water, which on acidification with aqueous HCl gives Stage‐III.

Stage‐IV: Azilsartan Medoxomil

A] Stage‐IV (Technical):

Stage‐III is reacted with 4‐Hydroxymethyl‐5‐methyl‐1,3‐dioxol‐2‐one, p‐TSCl, and DMAP, K2CO3

in DMAc as a solvent to give stage‐IV(Technical) after pouring in the process water.

B] Stage‐IV: Stage‐IV (Technical) is purified using mixture of acetone and water.

Stage‐V: Azilsartan medoxomil monopotassium salt.

Stage‐IV is treated with potassium 2‐ethyl hexanoate in presence of ethyl acetate as a solvent

to give potassium salt of Azilsartan Medoxomil.

2-94

Chemical Reaction

2-95

2-96

Material Balance

Total input Kgs.

Starting Material Product output AZILSARTAN‐I

Quantity Kgs.

Output Details

2.505 KSM 9.794 Aq. Effluent 4.233 Hydroxyl Amine‐HCI 1.328 Carbon Dioxide 6.462 Sodium Carbonate

13.200 Total

2.079kgs 11.122 Total

Total input Kgs.

Starting Material Product output AZILSARTAN‐II

Quantity Kgs.

Output Details

2.079 Stage‐I 1.335 Aq. Effluent 0.558 ECF 0.101 Carbon Dioxide 0.420 Potassium Carbonate

3.058 Total

1.622gs

1.436 Total

Total input Kgs.

Starting Material Product output AZILSARTAN‐III

Quantity Kgs.

Output Details

1.622 Stage II 1.949 Aq. Effluent 0.415 Sodium Hydroxide 0.036 Evaporation loss 1.051 hydrochloric acid

3.088 Total


Total input Kgs.

Starting Material Product output AZILSARTAN‐IV

Quantity Kgs.

Output Details

1.103 Stage III 0.491 4‐hydroxymethyyl‐5‐

methyl‐1,3‐dioxol‐2‐one(KRM)

0.636 p‐TSCI 1.679 Aq. Effluent 0.522 Potassium Carbonate 0.110 Carbon Dioxide 0.173 Acetic Acid 2.925 Total


Total input Kgs.


AZILSARTAN Quantity

Kgs. Output Details

1.136 Stage IV 0.534 Aq. Effluent 0.398 Potassium Ethyl Hexonate

1.534 Total

1.000kgs

0.534 Total

2-97

38. ETORICOXIB Manufacturing Process Stage‐1 Ketosulfone is reacted with CPT‐Phosphate in presence of Potassium tert‐Butoxide in Tetra hydrofurane to give Etoricoxib crude. Stage‐2 Etoricoxib crude recrystallized from IPA‐Hexane to give Etoricoxib Chemical Reaction Stage‐I: Preparation 2‐chloro malonaldehyde from sodium salt of 2‐chloromalonaldehyde Stage‐II: Preparation 3‐amino‐2‐ chloroacrolien from 2‐chloro‐malonaldehyde Stage‐III: Preparation of Etoricoxib hydrochloride

2-98

Stage‐IV: Preparation of Etoricoxib (API)

Material Balance Stage – 1

Total input Kgs

Starting Material Quantity

Kgs Output details

2.283 Acetic Acid 2.781 Acetone 2.657 Acetone Recovery

10.871 Ammonia Solution 0.124 Acetone Recovery Loss 2.520 CPT‐Phosphate 9.299 Isopropyl Alcohol Recovery

45.343 D M Water 0.469 Isopropyl Alcohol Recovery Loss 0.115 Hydroxylamine Hydrochloride 9.255 Methanol Recovery 0.177 Hyflow 0.452 Methanol Recovery Loss 9.768 Isopropyl Alcohol 50.546 Toluene Recovery 1.574 Ketosulfone 2.664 Toluene Recovery Loss 9.706 Methanol 0.664 Potassium Tertrabutoxide (KTB) 0.297 Sodium Acetate 88.627 Aqueous Effluent 3.153 Sodium Hydroxide

53.210 Toluene 22.273 Tri Hydrofuron

0.465 Trifluro Acetic Acid 165.200 Total

Product output Etoricoxib‐I 1.107 Kgs

164.093 Total

Stage – 2

Total input Kgs


Kgs Output details

0.022 Activated Carbon 1.107 Etoricoxib‐I 14.474 Isopropyl Alcohol Recovery 0.260 Hexane 0.813 Isopropyl Alcohol Recovery Loss 0.053 Hyflow

15.287 Isopropyl Alcohol 0.093 Spent Carbon 0.349 Aqueous Effluent

16.729 Total

Product output

Etoricoxib 1.00 Kgs

15.729 Total

2-99

BrH

NH

Ph

Ph

CN

M.F.:C 18H18N2M.W.: 343. 26

H2SO 4

L(+)-Tartaric acid

NH

Ph

Ph

CONH 2

HOOC

COOH

OHHHOH

M.F.:C 22H26N2O7M.W.: 430. 45

NaOH

MDC, Ethanol

+ NaBr

Sodium bromide+ Na2SO 4

Sodium suphate

CAS No.: [ 134002-26-9]CAS No.: [ 194602-27-2]

KSM-IStage-I

NH

Ph

Ph

CONH2

HOOC

COOH

OHHHOH

M.F.:C22H26N2O7

M.W.: 430. 45

+

KSM-IIM.F.:C10H11BrO

M.W.: 227. 09

Darifenacin base

BrH

O

N

Ph

Ph

CONH2

O

N

Ph

Ph

CONH2

Darifenacin hydrobromide

BrH

Acetone

DMF

K2CO3

+KOOC

COOK

OHHHOH

dipotassium tartarate

+KBr

Potassium bromide

+CO2

Carbon dioxide

+OH2

Water

CAS No.: [ 134002-26-9]CAS No.: [ 127264-14-6]

CAS No.: [ 133099-07-7]

M.F.:C28H31BrN2O2

M.W.:507. 462

Stage-I

O

Br

39. DERIFENACIN Manufacturing Process Stage‐I: Preparation of 3(S)‐(+)‐(1‐Carbamoyl‐1,1‐diphenylmethyl) pyrrolidine L‐(+)‐tartrate : 3‐(S)‐(+)‐(1‐Cyano‐1,1‐diphenylmethyl) pyrrolidine hydrobromide is hydrolysed using diluted Sulfuric acid which on basification with sodium hydroxide and further extraction with MDC provides 3(S)‐(+)‐(1‐Carbamoyl‐1,1‐diphenylmethyl) pyrrolidine. 3(S)‐(+)‐(1‐Carbamoyl‐1, 1‐diphenylmethyl) pyrrolidine L‐(+)‐tartrate was isolated as L (+) tartaric acid salt in absolute alcohol. Stage‐II: Preparation of Darifenacin hydrobromide: 3(S)‐(+)‐(1‐Carbamoyl‐1,1‐diphenylmethyl) pyrrolidine L‐(+)‐tartrate reacts with 5‐(2‐Bromoethyl)‐2,3‐dihydro‐1‐benzofuran in the presence of potassium carbonate in DMF to give Darifenacin base which on treatment with aqueous HBr and Acetone to give Darifenacin Hydrobromide. It is then purified in absolute alcohol. Chemical Reaction Stage‐I: Preparation of Stage‐I

Stage‐II: Preparation of Stage‐II

2-100

Material Balance

Total input Kgs.

Starting Material Product output DARIFFENACIN

HBr IA

Quantity Kgs.

Output details

2.307 KSM I 0.288 Sodium Hydroxide 0.807 Aqueous Effluent

0.035 Evaporation Loss

2.595 Total


Total input Kgs.


HBr I

Quantity Kgs.

Output details

1.753 Stage IA 0.263 Sodium Hydroxide 1.797 Aqueous Effluent 0.456 Sulphuric Acid 0.018 Evaporation loss 0.771 Tartaric Acid

3.244 Total


Total input Kgs.


HBr

Quantity Kgs.

Output details

1.429 Stage I 0.757 KSM II 2.414 Aqueous Effluent 2.286 Potassium Carbonate 1.357 Evaporation loss 0.300 Hydrogen Bromide

4.771 Total


2-101

40. CELECOXIB Manufacturing Process Stage‐1 & 2 A mixture of ethyl trifluoroacetate and 4 methyl acetophenone is reacted with Sodium methoxide in solvent media toluene at a under temperature. The reaction mass is then heated and maintained. The completion of the reaction is monitored on GC after which the reaction mass is subjected to work up in acidic medium of sulphuric acid solution. The product is thereafter washed with water and the resultant Toluene layer is distilled off and the residual oil is unloaded. This is stage‐I which is further analyzed before use.

Stage‐II

The stage obtained as above is then reacted with 4‐Sulfamoyl phenyl hydrazine hydrochloride in 12.5 % Aqueous Isopropyl alcohol followed maintaining of reaction mixture temp. The end point is monitored on GC and then the reaction mass is cooled and precipitated by addition of water. This precipitated mass is then centrifuged. The wet cake is then further purified in Aqueous Isopropyl alcohol and chilled then centrifuged and dried and packed. Chemical Reaction Stage‐I: Preparation of Ethyl trifluoroacetate Stage‐II: Preparation of 1‐ ( 4‐methylphenyl) 4, 4, 4‐trifluro butane 1, 3‐dione

2-102

Stage‐III: Preparation of Celecoxib Stage‐IV: Purification of Celecoxib

2-103

Material Balance Stage – 1

Total input Kgs


Kgs Output details

0.396 Trifluoro Acetic Acid 0.237 Ethyl Alcohol 0.225 Ethyl Trifluoro Acetate Recovery 0.190 Sulphuric Acid 0.013 Ethyl Trifluoro Acetate Recovery Loss

0.142 Aqueous Effluent 0.823 Total

Product output Celecoxib‐I 0.443 Kgs

0.380 Total

Stage – 2

Total input Kgs


Kgs Output details

2.113 Toluene 0.356 Sodium Methoxide 2.071 Toluene Recovery 0.325 Sulphuric Acid 0.042 Toluene Recovery Loss 0.019 Methanol 0.562 Ethyl Trifluoro Acetate 3.468 D M water 0.012 Acetic Acid 4.431 Aqueous Effluent 0.443 4‐Methylacetophenon 7.298

Product output Celecoxib‐II 0.754 Kgs

6.544 Total

Stage – 3

Total input Kgs


Kgs Output details

0.754 1‐(4‐Methylphenyl)‐4,4,4 Trifluorobutane 1,3‐dione

8.813 D M Water 8.033 Isopropyl Alcohol Recovery 8.447 Isopropyl Alcohol 0.414 Isopropyl Alcohol Recovery Loss 0.769 4‐Sulphonamino Phenyl Hydrazine

9.336 Aqueous Effluent

18.783 Total

Product output

Celecoxib 1 Kgs

17.783 Total

2-104

41. RABEPRAZOLE SODIUM

Manufacturing Process Stage‐I: 2‐[{4‐(3‐Methoxy propoxy)‐3‐methyl pyridine‐2‐yl} methyl thio] 1H benzimidazole 2‐Hydroxymethyl‐4‐(3‐methoxypropoxy)‐3‐methyl pyridine hydrochloride (RAB/Hydroxy) is reacted with thionyl chloride in MDC to get 2‐Chloromethyl‐4‐(3‐methoxypropoxy)‐3‐methyl pyridine hydrochloride (RAB/Chloro) is reacted with 2‐mercapto benzimidazole in presence of sodium hydroxide in methanol to form rabeprazole sulphide (RAB/I). Stage‐II: 2‐[{4‐(3‐Methoxy propoxy)‐3‐methyl pyridine‐2‐yl} methyl sulfinyl ] 1H benzimidazole (RAB/II) from 2‐[{4‐(3‐Methoxy propoxy)‐3‐methyl pyridine‐2‐yl} methyl thio] 1H benzimidazole Rabeprazole sulphide is reacted with sodium hypochlorite in mixture of isopropyl alcohol and methanol to form rabeprazole sulphoxide (RAB/II). Stage‐III: Rabeprazole sodium Rabeprazole sulphoxide is reacted with sodium hydroxide in methanol to form rabeprazole sodium. Chemical Reaction Step‐1: Preparation of stage‐I

2-105

Step‐2: Preparation of RAB/II from RAB/I Step‐3: Preparation of RAB/III from RAB/II

2-106

Material Balance

Total input Kgs.

Starting Material Product output RABEPRAZOLE

SODIUM I

Quantity Kgs.

Output details

1.097 RAB / Hydroxy 0.340 Aq. Effluent 0.636 Thionyl Chloride 0.011 Evaporation loss

0.285 Sulphur Dioxide

1.733 Total


Total input Kgs.


SODIUM IA

Quantity Kgs.

Output details

1.097 RAB / Chloro 0.910 Aq. Effluent 0.647 2‐Mercepto Benzimidazole 0.011 Evaporation loss 0.494 Sodium Hydroxide

2.237 Total

1.316 kgs 0.921 Total

Total input Kgs.


SODIUM II

Quantity Kgs.

Output details

1.316 RAB / I 4.291 Aq. Effluent 4.054 Sodium Hypo chloride 0.026 evaporation loss

5.370 Total


Total input Kgs.


SODIUM

Quantity Kgs.

Output details

1.053 RAB / II 0.811 Aq. Effluent 0.811 Sodium Hydroxide 0.053 evaporation loss

1.863 Total


2-107

42. CLOPIDOGREL BISULFATE Manufacturing Process The reaction of 2‐chlorophenylglycine with Thionyl chloride & methanol at RT for 48 hrs gives Hydrochloride salt of Methyl‐α‐amino(2‐chlorophenyl)acetate(Stage‐I) which is then react with sodium bicarbonate & Ethyl acetate followed by Methanol & L‐(+)‐tartaric acid gives L‐(+)‐Tartrate salt of S‐ Methyl‐α‐amino(2‐chlorophenyl) acetate(Stage‐II) Then Tartrate salt (stage‐II) reacts with sodium bicarbonate & dichloromethane followed by Tosylate of 2‐Thiophene ethanol(stage‐III) & K2HPO4 gives Methyl (2S)‐(2‐chlorophenyl){[2‐(2‐thienyl)ethyl] amino}acetate(stage‐IV). Stage‐IV reacts with (41%) formaldehyde solution followed by Conc. Sulphuric acid to gives Clopidogrel bisulfate (stage‐V). Chemical Reaction Material Balance

Total input Kgs.

Starting Material Product output CLOPIDOGREL‐I

Quantity Kgs.

Output Details

5.087 DL‐2‐chlorophenyl glycine 16.379 Aq. Effluent 6.816 Thionyl Chloride 1.729 Sulphur dioxide

12.310 Methanol

24.213 Total

6.104kgs 18.109 Total

Total input


Product output CLOPIDOGREL‐II

Quantity Kgs.

Output Details

6.104 Stage I 8.912 Aq. Effluent 3.357 Sodium Bicarbonate 1.160 Carbon Dioxide 3.662 Tartaric Acid

13.124 Total

3.052kgs

10.072 Total

2-108

Total input


Product output CLOPIDOGREL‐III

Quantity Kgs.

Output Details

3.052 2‐Thiophene ethanol 8.922 Aq. Effluent 4.975 Triethyl Amine 0.02 Evaporation Loss

3.967 p‐toluene Sulphonyl chloride

11.994 Total

3.052kgs

8.942 Total

Total input Kgs.


CLOPIDOGREL‐IV‐A

Quantity Kgs.

Output Details

3.052 Stage II 2.838 Aq. Effluent 1.831 Sodium Bicarbonate 0.397 Carbon Dioxide

4.883 Total

1.648kgs

3.235 Total

Total input Kgs.


CLOPIDOGREL‐IV Quantity

Kgs. Output Details

1.648 N‐(3‐chloro‐4‐methoxyphenyl)acetamide 32.017 Aq. Effluent

1.510 Dipotassium hydrogen sulphate

1.590 2‐Thienylethyl para‐toluene sulphonate

0.652 Hydrochloric Acid 27.508 DM Water 32.907 Total

0.890kgs

32.017 Total

Total input Kgs.


CLOPIDOGREL‐V‐A

Quantity Kgs.

Output Details

0.890 Stage IV 1.346 Aq. Formaldehyde 0.954 Aq. Effluent

2.236 Total

1.282kgs

0.954 Total

Total input Kgs.

Starting Material

Product output CLOPIDOGREL

HYDROGEN SULPHATE

Quantity Kgs.

Output Details

1.282 Free Base 0.628 Aq. Effluent 0.368 Sulphuric Acid 0.022 Evaporation Loss

1.650 Total

1.000kgs

0.650 Total

2-109

43. FELODIPINE Manufacturing Process 2, 3‐dichloro Benzaldehyde is condensed with Methylacetoacetate in presence of Formic acid and Piperidine at 60‐65°C to give Monomethyl ester. Monomethyl ester is reacted with 3‐amino crotonic acid ethyl ester at 80‐85°C to give Felodipine Crude. Felodipine Crude is purified in the mixture of Cyclohexane: Isopropyl alcohol to give Felodipine. Reaction Balance Material Balance

Total input Kgs.

Starting Material Product output FELODIPINE‐I

Quantity Kgs.

Output Details

0.667 2,3 Dichloro Benzaldehyde 0.127 Aq. Effluent 0.465 Methyl Aceto Acetate 0.005 Evaporation Loss

1.131 Total

1.000kgs

0.131 Total

Total input Kgs.


FELODIPINE Quantity

Kgs. Output Details

1.000 2,3 Dichlorobenzylidine Methylacetoacetate 0.560 Aq. Effluent

0.630 3‐Amino Crotonic acid Ethyl ester 0.070 Evaporation Loss

1.630 Total


2-110

44. PRASUGREL HYDROCHLORIDE Manufacturing Process Stage‐I : 2‐ Oxo‐2,4,5,6,7,7a‐hexahydrothieno[3,2‐c] pyridine hydrochloride. 2‐ Oxo‐2,4,5,6,7,7a‐hexahydrothieno[3,2‐c] pyridine hydrochloride ( Stage‐I) is obtained by stirring 5‐triphenylmethyl‐2‐ oxo‐2,4,5,6,7,7a‐hexahydrothieno[3,2‐c]pyridine and conc.hydrochloric acid in acetone at 55‐60°C . (Detritylation) Stage‐II: 2‐Acetoxy‐5‐( α –cyclopropylcarbonyl‐2‐fluorobenzyl) ‐ 4,5,6,7‐ tetrahydrothieno [3,2‐c] pyridine ( Prasugrel crude ) . 2‐Oxo‐2,4,5,6,7,7a‐hexahydrothieno[3,2‐c] pyridine hydrochloride is treated with α –cyclopropyl carbonyl‐2‐fluorobenzylbromide in presence of sodium bicarbonate in dimethylformamide to yield 2‐oxo‐5‐( α –cyclopropyl carbonyl‐2‐fluorobenzyl)‐ 2,4,5,6,7,7a‐hexahydrothieno [3,2‐c] pyridine. The above compound is not isolated and further treated with acetic anhydride to yield Prasugrel (Stage‐II). (Nucleophilic substitution) Stage‐III: 2‐Acetoxy‐5‐( α –cyclopropylcarbonyl‐2‐fluorobenzyl) ‐ 4,5,6,7‐ tetrahydrothieno [3,2‐c] pyridine ( Prasugrel pure). 2‐Acetoxy‐5‐( α –cyclopropylcarbonyl‐2‐fluorobenzyl) ‐ 4,5,6,7‐ tetrahydrothieno [3,2‐c] pyridine is purified by making its maleate salt, which on further treatment with sodium bicarbonate in ethyl acetate followed by purification in isopropanol yields Prasugrel free base ( Stage‐III). Stage‐IV: 2‐Acetoxy‐5‐( α –cyclopropylcarbonyl‐2‐fluorobenzyl) ‐ 4,5,6,7‐ tetrahydrothieno [3,2‐c] pyridine hydrochloride ( Prasugrel hydrochloride ) (API). The hydrochloride is prepared by dissolving 2‐acetoxy‐5‐( α –cyclopropylcarbonyl‐2‐fluorobenzyl) ‐ 4,5,6,7‐ tetrahydrothieno [3,2‐c] pyridine Prasugrel (Stage‐III) in ethyl methyl ketone at 35‐40°C followed by addition of IPA.HCl The solid obtained is filtered to yield 2‐acetoxy‐5‐( α –cyclopropylcarbonyl‐2‐fluorobenzyl) ‐ 4,5,6,7‐ tetrahydrothieno [3,2‐c] pyridine hydrochloride ( Prasugrel hydrochloride ) (API).

2-111

N

S

C(C6H5)3

ONH

S

OAcetone / HCl

5-Triphenylmethyl-2-oxo-2,4,5,6,7,7a-hexahydro[3,2-c]pyridineM F C26H23NOSF W 397.53CAS No[109904-26-9]

.HCl

2-oxo-2,4,5,6,7,7a-hexahydro[3,2-c]pyridine hydrochloride MF C7H10NOSClFW 191.71CAS No[115473-15-9]

+(C6H5)3C-OH

Triphenyl methanolMF C19H16OFW 260.33[76-84-6]

NH

S

OF

O

Br

FO

N

S

O

FO

N

S

AcO

.HCl DMF,NaHCO3Acetic anhydride

2-Acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-,4,5,6,7-tetraahydrothieno[3,2-c]pyridineM F C20H20FNO3SF W 373.44CAS No[150322-43-3]Stage-II

α-Cyclopropylcarbonyl-2-fluorobenzylbromide

MFC11H10BrFO

FW257.09

CAS No[204205-33-4]

KSM-2

2-Oxo-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-2,4,5,6,7,7a-hexahydrothieno[3,2-c]pyridineM F C18H18FNO2SF W 331.40CAS No[152322-38-6]

Methanol

+

NaCl + NaBr + 2 H2O + 2 CO2 + CH3COOH + CH3COONa Sodium chloride Sodium bromide Acetic acid Sodium acetate MWNaCl MWNaBr MWC2H4O2 MWC2H3O2NaFW 58.44 FW 102.89 FW 60.05 FW 82.03CAS No [7647-14-5] CAS No [7647-15-6] CAS No [64-19-7] CAS No [127-09-3]

2-Oxo-2,4,5,6,7,7a-hexahydrothieno[3,2-c]pyridine hydrochlorideM F C7H10NOSClF W 191.71CAS No[115473-15-9]Stage-I

F

O

N

S

AcO

FO

N

S

AcO

Ethyl acetateAcetone

FO

N

S

AcO

NaHCO3

OH

OH

O

O

.

2-Aceoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine maleateM F C24H24FNO7SF W 489.51

2-Aceoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridineM F C20H20FNO3SF W 373.44 CAS No[150322-43-3]Stage-II

2-Aceoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine

M F C20H20FNO3SF W 373.44CAS No[150322-43-3] Stage-III+ ONa

ONa

O

O

Maleic acid disodiumsaltM F C4H2Na2O4

FW 160.03582[371-47-1]

+ 2 H2O + 2 CO2

OH

OH

O

O

Maleic acid

MWC4H4O4

FW116.07

CAS No[110-16-7]

Chemical Reaction Stage‐I : 2‐ Oxo‐2,4,5,6,7,7a‐hexahydrothieno[3,2‐c] pyridine hydrochloride.

Stage‐II : 2‐Acetoxy‐5‐( α –cyclopropylcarbonyl‐2‐fluorobenzyl) ‐ 4,5,6,7‐ tetrahydrothieno [3,2‐c] pyridine( Prasugrel crude ). Stage‐III : 2‐Acetoxy‐5‐( α –cyclopropylcarbonyl‐2‐fluorobenzyl) ‐ 4,5,6,7‐ tetrahydrothieno [3,2‐c] pyridine (Prasugrel pure ).

2-112

Ethyl methyl ketone

FO

N

S

AcO .HCl

FO

N

SAcO

2-Acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridineM F C20H20FNO3SFW 373.44 CAS No [150322-43-3]Stage-III

2-Acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine hydrochlorideM F C20H21FNO3SClFW 409.9 CAS No [389574-19-0]Stage-IV

HCl in isopropanol

Stage‐IV: 2‐Acetoxy‐5‐( α –cyclopropylcarbonyl‐2‐fluorobenzyl) ‐ 4,5,6,7‐ tetrahydrothieno [3,2‐c] pyridine hydrochloride ( Prasugrel hydrochloride) (API). Material Balance

Total input Kgs.


PRASUGREL. HCl I Quantity

Kgs. Output details

1.804

5‐Triphenylmethyl‐2‐Oxo‐2,4,5,6,7,7a‐Hexahydro Thieno[3,2‐c] Pyridine 32.787 Aq. Effluent

31.356 Acetone 0.036 Evaporation loss 0.529 Hydrochloric Acid

33.689 Total

0.866kgs

32.823 Total

Total input Kgs.


PRASUGREL. HCl IIA

Quantity Kgs.

Output details

0.866 Stage I 2.382 Aq. Effluent 1.516 KSM Stage II 0.017 Evaporation loss

1.516 Sodium Bicarbonate

0.199 Carbon Dioxide

3.897 Total


Total input


Product output PRASUGREL. HCl II

Quantity Kgs.

Output details

1.299

2‐Oxe‐(Cyclopropylcabonyl‐2‐Fluorobenzyl)‐2,4,5,6,7,7a‐HexahydroThieno[3,2‐C] Pyridine 2.208 Aq. Effluent

1.533 Acetic Anhydride 0.039 Evaporation loss 0.649 Sodium Biocarbonate

3.481 Total

1.234kgs

2.247 Total

2-113

Total input Kgs.


PRASUGREL. HCl IIIA

Quantity Kgs.

Output details

1.234 Stage II 0.154 Aq. Effluent 0.402 Maleic Acid 0.001 Evaporation loss

1.637 Total


Total input Kgs.


PRASUGREL. HCl III

Quantity Kgs.

Output details

1.481

2‐Acetoxy‐5‐(Cyclopropylcarbonyl‐2‐Fluorobenzyl)‐4,5,6,7‐Tetrahydrothieno[3,2‐c] Pyridine Maleate 0.770 Aq. Effluent

0.726 Sodium Bicarbonate 0.059 Evaporation loss 0.267 Carbon Dioxide

2.207 Total


Total

input Kgs.


PRASUGREL. HCl Quantity

Kgs. Output details

1.111 Stage III 0.967 Aq. Effluent 0.879 Hydrochloric Acid 0.023 Evaporation loss

1.990 Total


2-114

CH3

OH

CH3

CH3CH3

O

CH3

OK2CO 3 , KIO

CH3

ClAcetone

2, 6-xylenol

Stage-Ia

576 -26-1

MW 122 . 16 178 . 23

+

chloro acetone

92. 52

MF C8H10O C3H5ClO C11H14O2

CAS NO. 78-95-5

+

53012 -41-2

1-( 2, 6-dimethylphenoxy)- 2-propanone

CH3CH3

O

CH3

O

CH3

CH3

ON

CH3

OHNH 2OH . HCl

Na 2CO 3TOLUENE

Stage-Ia (stage-I )

178 . 23 193 . 24

C11H14O2C11H15NO 2

+

hydroxyl amine hydrochloride

69. 5

NH 4ClO

5470 -11-153012 -41-2 55304 -19-3

1-( 2, 6-dimethylphenoxy)- 2-propane oxime

H2O CO 2+ + KCl

NaCl H2O CO 2+ + +

45. MEXILETINE HYDROCHLORIDE Manufacturing Process Stage‐I: Preparation of 1‐(2’, 6’‐dimethylphenoxy)‐2‐propane oxime 2, 6‐xylenol is reacted with mono‐Chloro acetone in presence of potassium carbonate and potassium iodide in acetone to gives in‐situ intermediate. This is reacted with hydroxyl amine HCl in the presence of sodium carbonate in to toluene gives Stage‐I. Stage‐II: Preparation of 1‐(2’,6’‐dimethylphenoxy)‐2‐propane amine (Mexiletine base) Catalytic Hydrogenation of oxime derivative in methanol using Raney Ni gives Mexiletine Base. Stage‐III: Preparation of 1‐(2’, 6’‐dimethylphenoxy)‐2‐propane amine hydrochloride Mexiletine Hydrochloride prepared from Mexiletine Base by adding Methanolic HCl in Acetone Chemical Reaction Stage‐I: Preparation of 1‐(2’, 6’‐dimethylphenoxy)‐2‐propane oxime

2-115

CH3

O

CH3

CH3

NH2

CH3

O

CH3

N

CH3

OH

MeOH

H2 / Raney Ni

stage-I stage-II

MW 193. 24 179. 3

M F C11H15NO2 C11H17NO

CAS NO. 31828-17-455304-19-3

1-( 2, 6-dimethylphenoxy)- 2-propane oxime 1-( 2, 6-dimethylphenoxy)- 2-propane amine

H2O+

CH3

CH3

ONH2

CH3 CH3

O

CH3

CH3

NH2

C 11H18ClNOC11H17NO

179 . 3215 . 8

. HClMethanolic HClAcetone

stage-II (Mexiletine Base) Mexiletine Hydrochloride

MW

MF

CAS NO. 31828 -71 -4 5370 -01-4

Stage‐II: Preparation of 1‐(2’, 6’‐dimethylphenoxy)‐2‐ propane amine (Mexiletine base)

Stage‐III: Preparation of 1‐(2’, 6’‐dimethylphenoxy)‐2‐ propane amine hydrochloride

2-116

Material Balance

Starting Material

Product output MEXILETINE

HYDROCHLORIDE ‐1A

Quantity Kgs.

Output details

0.781 2‐Phenyl ethanol 1.406 Aq. Effluent 0.648 Epichlorohydrine 0.023 Evaporation loss 1.058 Potassium carbonate 0.087 Carbon Dioxide 0.064 Potassium Iodide

2.551 Total


Total input Kgs.

Starting Material


HYDROCHLORIDE ‐I

Quantity Kgs.

Output details

1.035 p‐Methoxy‐Benzyl acetone (stage I) 1.666 Aq. Effluent

0.652 Hydroxylamine Hydrochloride 0.062 Evaporation loss

1.407 Sodium carbonate

3.094 Total


Total input Kgs.

Starting Material


HYDROCHLORIDE II

Quantity Kgs.

Output details

1.366 3,4‐Methylene Dioxymetham Phetamine(Stage I) 0.387 Aq. Effluent

0.027 Hydrogen Gas 0.007 Evaporation loss

1.393 Total

0.999kgs

0.394 Total

Total input Kgs.

Starting Material


HYDROCHLORIDE III

Quantity Kgs.

Output details

0.990 Mexiletine 0.198 Aq. Effluent 0.218 Hydrogen chloride 0.010 Evaporation loss

1.208 Total

1.000 kgs 0.208 Total

2-117

46. WARFARIN Manufacturing Process 2‐Hydroxy acetophenone is condensed with diethyl carbonate in presence of sodium methoxide in toluene to give 4‐Hydroxy Coumarin. 4‐Hydroxy Coumarin is reacted with benzal acetone in presence of Triethyl amine in water to give Warfarin acid. Warfarin sodium is formed by reaction with sodium hydroxide in a mix of methanol and isopropyl alcohol at 20‐25°C. Chemical Reaction

2-118

Material Balance

Total input Kgs.

Starting Material

Product output WARFARINE

SODIUM CLATHRATE I

Quantity Kgs.

Output details

0.769 2‐Hydroxy Acetophenone 1.731 Aq. Effluent 1.000 Diethyl Carbonate 0.031 Evaporation loss 0.762 Sodium Methoxide

2.531 Total


Total input Kgs.

Starting Material

Product output WARFARINE

SODIUM CLATHRATE

Quantity Kgs.

Output details

0.769 4‐Hydroxy Coumarine 0.508 Aq. Effluent 0.693 Benzal Acetone 0.001 Evaporation loss 0.046 Triethylamine

1.508 Total


2-119

47. BAZEDOXIFENE Manufacturing Process

Stage‐I: Preparation of Benzyl‐4‐nitrophenylether (Nitro Compound)

4‐Nitrophenol is Benzylated using Benzyl chloride in presence of Potassium Carbonate as a base and Potassium Iodide as a catalyst in Acetone to furnish Benzyl‐4‐nitrophenylether (Nitro Compound). This on further removal of solvent isolated from water.

Stage‐II: Preparation of 4‐(Benzyloxy)aniline Hydrochloride (Amine, KSM‐I)

Benzyl‐4‐nitrophenylether (Nitro Compound) is reduced in presence of Anhydrous Ferric chloride and Hydrazine Hydrate in Isopropanol to give 4‐(Benzyloxy)aniline Hydrochloride (Amine, KSM‐I). Finally the free base converted to its hydrochloride salt using concentrated Hydrochloric acid in water.

Stage‐III: Preparation of 5‐(Benzyloxy)‐2‐[4‐(benzyloxy)phenyl]‐3‐methyl‐indole (Indole)

1‐[4‐(Benzyloxy)phenyl]‐2‐bromopropan‐1‐one is condensed with 4‐(Benzyloxy)aniline Hydrochloride in presence of Triethylamine using Dimethylformamide as a solvent. This is further heated to 128°C to furnish Indole after removal of water molecule. Finally compound isolated from mixture of Ethyl acetate and Methanol.

Stage‐IV: Preparation of 5‐(Benzyloxy)‐2‐[4‐(benzyloxy)phenyl]‐3‐1‐[4‐(2‐hexamethyleneimine‐1‐yl‐ ethoxy)benzyl]‐1H‐indole (Benzyl Bazedoxifene)

5‐(Benzyloxy)‐2‐[4‐(benzyloxy)phenyl]‐3‐methyl‐indole (Indole) is condensed with 1‐{2‐[4‐(Chloromethyl)phenoxy]ethyl}azepane Hydrochloride in Dimethyl formamide and Sodium tert butoxide to give crude 5‐(Benzyloxy)‐2‐[4‐(benzyloxy)phenyl]‐3‐1‐[4‐(2‐hexamethyleneimine‐1‐yl‐ethoxy)benzyl]‐1H‐indole (Benzyl Bazedoxifene). The crude compound is purified in Ethyl acetate and Methanol mixture. Stage V : Preparation of 1‐{4‐[2‐(Azepan‐1‐yl)ethoxy]benzyl}‐2‐(4‐hydroxyphenyl)‐3‐methyl‐1H‐indol‐5‐ol Acetate 5‐(Benzyloxy)‐2‐[4‐(benzyloxy)phenyl]‐3‐1‐[4‐(2‐hexamethyleneimine‐1‐yl‐ethoxy)benzyl]‐1H‐indole (Benzyl Bazedoxifene) is hydrogenated over palladium on carbon and Hydrogen to give Bazedoxifene free base. This free base treated with Acetic acid in Acetone to Give Bazedoxifene Acetate.

2-120

Chemical Reaction

Stage‐I: Preparation of Benzyl‐4‐nitrophenylether (Nitro Compound)

Stage‐II: Preparation of 4‐(Benzyloxy) aniline Hydrochloride (Amine, KSM‐I)

Stage‐III: Preparation of 5‐(Benzyloxy)‐2‐[4‐(benzyloxy)phenyl]‐3‐methyl‐indole (Indole)

NO2

O

MF = C13H11NO3

MW = 229.23

MF = C6H5NO3

MW = 139.10

Anhydrous K2CO3

Acetone

NO2

OH

4-Nitrophenol

+

Cl

Benzyl chloride

MF = C7H7Cl

MW = 126.58

Potassium Iodide

Benzyl 4-nitrophenyl ether

NH2

O

4-(Benzyloxy)aniline Hydrochloride

MF = C13H13NO

ClH

MW = 235.70

NO2

O

Benzyl 4-nitrophenyl ether

MF = C13H11NO3

MW = 229.23

NH2 NH2 OH2

Anhydrous FeCl3

Isopropylalcohol

O

Br

CH3

O

NH2

O

+

1-[4-(Benzyloxy)phenyl]-2-bromopropan-1-one 4-(Benzyloxy)aniline Hydrochloride

Dimethyl formamide

Triethyl amine

MF = C16H15BrO2 MF = C13H13NO

MW = 319.19

ClH

MW = 235.70

NH

O

O

CH3

MF = C29H25NO2

MW = 419.51

+ N

CH3 CH3

CH3

Triethylamine hydrobromide

MW = 182.10

BrH

5-(Benzyloxy)-2-[4-(benzyloxy)phenyl]-3-methyl-indole

+ OH2

2-121

Stage‐IV: Preparation of 5‐(Benzyloxy)‐2‐[4‐(benzyloxy)phenyl]‐3‐1‐[4‐(2‐hexamethyleneimine‐1‐yl‐ ethoxy)benzyl]‐1H‐indole (Benzyl Bazedoxifene)

Stage V : Preparation of 1‐{4‐[2‐(Azepan‐1‐yl)ethoxy]benzyl}‐2‐(4‐hydroxyphenyl)‐3‐methyl‐1H‐indol‐5‐ol Acetate

NH

O

O

CH3

MF = C29H25NO2

MW = 419.51

5-(Benzyloxy)-2-[4-(benzyloxy)phenyl]-3-methyl-indole

Cl

ON

+

MF = C15H22ClNO. HCl

MW = 304.25

ClH

N

O

O

CH3

ON

1-{2-[4-(Chloromethyl)phenoxy]ethyl}azepane Hydrochloride

+CH3

CH3

CH3 ONa+

2NaCl2

+ CH3

CH3

CH3 OH

2

5-(Benzyloxy)-2-[4-(benzyloxy)phenyl]-3-1-[4-(2-hexamethyleneimine-1-yl-ethoxy0benzyl]-1H-indole

+

5-(Benzyloxy)-2-[4-(benzyloxy)phenyl]-3-1-[4-(2-hexamethyleneimine-1-yl-ethoxy 0benzyl]-1H-indole

N

O

O

CH3

ON

CH3

N

OH

OH

CH3

ON

CH3COOH

1-{4-[Azepan-1-yl)ethoxy]benzyl}-2-(4-hydroxyphenyl)-3-methyl-1H-indol-5-ol Acetate

+ H2

2-122

Material Balance

Total input Kgs.

Starting Material Product Output

BAZEDOXIFENE‐I Quantity

Kgs. Output Details

0.819 4‐Nitrophenol(P‐Nitro phenol) 1.490 Aq. Effluent

0.729 Benzyl chloride 0.065 Carbon Dioxide

1.138 Anhydrous Potassium Carbonate

0.098 Potassium Iodide

2.783 Total


Total input


Product Output BAZEDOXIFENE‐II

Quantity Kgs.

Output Details

1.228 Benzyl‐4‐nitrophenylether(Nitro compound)

0.012 Anhydrous Ferric Chloride 0.123 Charcoal 0.123 Activated Charcoal 0.197 Hydrochloric Acid 1.130 Aq. Effluent 0.860 Hydrazine Hydrate 2.420 Total


Total input


Product Output BAZEDOXIFENE‐III

Quantity Kgs.

Output Details

1.167

(Benzyloxy)phenyl]‐2‐bromopropan‐1‐one (Bromo 3.177 Aq. Effluent

2.147 (Benzyloxy)Aniline Hydrochloride(Amine, 0.070 evaporation loss

0.924 Triethylamine 4.239 Total

0.992kgs

3.247 Total

Total input


Product Output BAZEDOXIFENE‐IV

Quantity Kgs.

Output Details

0.992 [4‐(benxyloxy)phenyl]‐3‐methyl‐indole(Indole) 1.415 Aq. Effluent

1.082 (Chloromethyl)phenoxy]ethyl}azepane 0.030 Evaporation Loss

0.909 Sodium‐tert‐butoxide

2.983 Total

1.538kgs

1.445 Total

Total input


Product Output BAZEDOXIFENE

Quantity Kgs.

Output Details

1.538 5‐(benxyloxy)‐2‐[4‐(phenyl)phenyl]‐3‐methyl 0.431 Recovery

0.015 Hydrogen 0.262 Evaporation Loss 0.138 Acetic Acid 1.692 Total

1.000 kgs 0.692 Total

2-123

48. BOSENTAN Manufacturing Process Guiacol and diethyl chloromalonate were added drop wise in succession to a previously prepared sodium ethoxide solution. The suspension was stirred at 45oC with exclusion of moisture. Thereafter the ethanol was distilled off. The residue was taken up in toluene, wash with water and 1% sodium hydroxide solution until organic phase gets colorless. Finally wash with water and sat. brine solution. After drying on sodium sulfate and evaporating the solvent, the residue was distilled to give diethyl (O‐ethoxyphenoxy) malonate. Pyrimidine‐2‐carboxamidine hydrochloride and diethyl (O‐ethoxyphenoxy)malonate were added while cooling with ice to a previously prepared sodium methoxide solution from sodium and absolute methanol. Stir the reaction mixture at room temperature with the exclusion of moisture. Solvent was evaporated under reduced pressure. The residue was taken up in 1N NaOH solution. Alkaline solution was acidified with 1N HCl. Precipitate was filtered off and washed thoroughly with water and dried under vacuum. The 5‐(2‐methoxy‐phenoxy)‐2‐(pyrimidin‐2‐yl) tetrahydro‐pyrimidine‐4,6‐dione used in the next step without further purification. Pyrimidinone from step‐II was charged in to N, N diisopropyl‐N‐ethylamine. Phosphorous pentachloride (PCl5) was added portion wise. Reflux the reaction mixture. The mixture was then evaporated under reduced pressure. Residue was poured on to ice and extracted with ethyl acetate. The combined extracts were washed with water, dried and evaporated in a vacuum. The residue was chromatographed on silica gel using ethyl acetate yielded 4,6‐dichloro‐5‐(2‐methoxy‐phenoxy)‐2,2’‐bipyrimidine. To a solution of Step‐III in DMSO, p‐tert‐butylbenzenesulphonamide was added. The mixture was heated at 100oC. The solution was concentrated under vacuum. The oily residue was poured on to ice, and adjusted pH 3. The suspension was extracted with ethyl acetate, combined organic layers and washed with water. Dried over sodium sulphate and concentrated under reduced pressure. The residue was chromatographed on silica gel with toluene‐ethyl acetate 9:1 to give 4‐tert‐butyl‐N‐[6‐chloro‐5‐(2‐methoxy‐phenoxy)‐2‐(pyrimidin‐2‐yl)‐pyrimidin‐4‐yl]‐benzenesulphonamide. To a solution of sodium metal in ethylene glycol, charged Step 04. The mixture was heated at 100oC. After completion of reaction, the reaction mass was poured on to ice and adjusted to PH=3 with 1M tartaric acid. The suspension was extracted with ethyl acetate. Combined organic layers were washed with water, dried over sodium sulphate and concentrated under reduced pressure. The residue was chromatographed on silica gel with dichloromethane‐‐ethyl acetate 9:1 to yield 4‐tert‐butyl‐N‐[6‐(2‐hydroxy‐ethoxy)‐5‐(2‐methoxy‐phenoxy)‐2‐(pyrimidin‐2‐yl)‐pyrimidin‐4‐yl]‐benzenesulphonamide (Bosentan)

2-124

Chemical Reaction

2-125

2-126

Material Balance

Total input Kgs.


BOSENTAN MONOHYDRATE I

Quantity Kgs.

Output details

0.726

4,6‐Dichloro‐5‐(2‐Methoxyphenoxy)‐2,2‐Bipysimidine 0.980 Aq. Effluent

0.443 4‐Tert‐Butylbenzene Sulfonamide 0.019 Evaporation loss

0.116 Hydrochloric Acid 0.094 Carbon Dioxide 0.862 Potassium Carbonate

2.147 Total

1.053kgs

1.094 Total

Total input Kgs.

Starting Material

Product output BOSENTAN

MONOHYDRATE IA

Quantity Kgs.

Output details

1.053 BOS / I (Crude) 0.053 Aq. Effluent

1.053 Total


Total input Kgs.


BOSENTAN MONOHYDRATE II

Quantity Kgs.

Output details

1.000 BOS / I (Pure) 13.594 Aq. Effluent 0.998 Sodium Tert Butoxide 0.033 Evaporation loss

12.339 Ethylene Glycol 0.344 Potassium Carbonate

14.680 Total

1.053kgs 13.627 Total

Total input Kgs.

Starting Material

Product output BOSENTAN

MONOHYDRATE III

Quantity Kgs.

Output details

1.053 BOS / II 8.463 Aq. Effluent 8.421 Water 0.021 Evaporation loss 0.063 Hydrochloric Acid

9.537 Total


Total input Kgs.


BOSENTAN MONOHYDRATE

Quantity Kgs.

Output details

1.053 BOS / IV 0.053 Aq. Effluent

1.053 Total


2-127

49. FEBUXOSTATE Manufacturing Process Ethyl‐2‐(3‐formyl‐4‐isobutoxyphenyl)‐4‐methylthiazole‐5‐carboxylate is reacted with hydroxylamine hydrochloride to form oxime which is dehydrated with sodium formate & formic acid to form Ethyl 2‐(3‐cyano‐4‐isobutoxyphenyl)‐4‐methyl‐5‐thiazolecarboxylate which on hydrolysis gives Febuxostate. Chemical Reaction

2-128

2-129

Material Balance

Total input Kgs.

Starting Material Product output FEBUXOSTAT I

Quantity Kgs.

Output details

1.547 KSM 1.162 Isobutyl Bromide 2.841 Aqueous Effluent 1.834 Potassium Carbonate 0.232 Evaporation Loss

4.543 Total

1.470 kgs 3.073 Total

Total input Kgs.

Starting Material Product output FEBUXOSTAT II

Quantity Kgs.

Output details

1.470 (Ethyl 2‐(3‐Formyl‐4‐Isobutoxyphenyl)‐4‐Methylthiazole‐5‐Carboxylate)

0.323 Ammonium Hydroxide. HCl 0.535 Aqueous Effluent 0.314 Sodium Carbonate 0.220 Evaporation loss

2.107 Total

1.352 kgs

0.755 Total

Total input Kgs.

Starting Material Product output FEBUXOSTAT III

(Tech)

Quantity Kgs.

Output details

1.352 (Ethyl 2‐(3‐Cyano‐4‐Isobutoxyphenyl)‐4‐Methyl‐5‐thiazoleCarboxylate)

0.297 Sodium Hydroxide 0.676 Aqueous Effluent 0.289 Hydrochloric Acid 0.113 Evaporation loss

1.938 Total

1.149 kgs 0.789 Total

Total input Kgs.

Starting Material Product output FEBUXOSTAT

Quantity Kgs.

Output details

1.149 Stage III (Tech) 0.750 Acetone 1.399 Aqueous Effluent 1.200 Water 0.700 Solvent Recovery

3.099 Total

1.000 kgs 2.099 Total

2-130

50. DRONEDARONE Manufacturing Process Reaction between 2‐n‐Butyl‐5‐nitrobenzofuran and 4‐Methoxy Benzoyl chloride in presence of Stannic chloride and on further reaction with Aluminum chloride gives an intermediate. Which on further reaction with 1‐Chloro‐3‐di‐n‐butylaminopropane gives 2‐n‐Butyl‐3‐[4‐(3‐di‐n‐butylaminopropoxy) Benzoyl]‐5‐nitrobenzofuran. Further on reduction and reaction with Methanesulphonyl chloride obtained Dronedarone base which is finally converted into its hydrochloride. Chemical Reaction

2-131

2-132

Material Balance

Total input Kgs.

Starting Material Product output DRONEDARONE

IA

Quantity Kgs.

Output details

1.073

2‐N‐Butyl‐3‐(4‐Hydroxybenzoyl)‐5‐Nitrobenzofuran 0.654 Aq. Effluent

0.714 1‐Chloro‐3‐Dibutyl Amino propane 0.003 Evaporation loss

0.480 Potassium carbonate

2.267 Total


Total input Kgs.


DRONEDARONE I B

Quantity Kgs.

Output details

1.610

2‐N‐Butyl‐3‐(4‐(3‐Dibutylaminopropo)Benzoyl)‐5‐Nitrobenzofuran 1.256 Aq. Effluent

0.016 Hydrogen Gas 0.038 Evaporation loss 1.294 Oxalic Acid Dihydrate

2.920 Total

1.626KGS 1.294 Total

Total input


Product output DRONEDARONE II

Quantity Kgs.

Output details

1.626

2‐N‐Butyl‐3‐(4‐(3‐Dibutylaminopropoxy‐benzoyl)‐5‐Amonibenzofuran Dioxalate 1.577 Aq. Effluent

1.138 Aq. Ammonia Solution 0.005 Evaporation loss

2.764 Total


Total input Kgs.


IIB

Quantity Kgs.

Output details

1.182

2‐N‐Butyl‐3‐(4‐(3‐Dibutylaminopropoxy‐benzoyl)‐5‐Amonibenzofuran Pure 0.189 Aq. Effluent

0.253 Methane Sulfonyl chloride 0.015 Evaporation loss 0.141 Pyridine

1.575 Total


2-133

Total input Kgs.


IIC

Quantity Kgs.

Output details

1.371

2‐N‐Butyl‐3‐(4‐(3‐Dibutylaminopropoxy‐benzoyl)‐5‐Amonibenzofuranamidobezofuran 0.070 Aq. Effluent

1.283 Ethyl Acetate HCl 0.003 evaporation loss 1.361 Solvent Recovery

2.654 Total

1.220kgs

1.434 Total

Total input Kgs.


III

Quantity Kgs.

Output details

1.220 Dronedarone HCl crude 0.195 Aq. Effluent 0.024 Evaporation loss

1.220 Total


2-134

51. DABIGATRAN Manufacturing Process Stage‐I : 1‐Methyl‐2‐[N‐(4‐cyanophenyl)‐aminomethyl]benzimidazol‐5‐yl‐carboxylic acid‐N‐

(2‐pyridyl)‐N‐(2‐ethoxycarbonylethyl)‐amide

To a suspension of N‐(4‐cyanophenyl) glycine in Toluene and 1‐methyl‐2‐pyrrolidone, Pivaloyl

chloride and N,N‐Diisopropylethylamine were added at ‐10 to ‐2 oC, followed by Ethyl‐3‐[{[3‐

amino‐4‐(methylamino)phenyl]carbonyl}(pyridin‐2‐yl)amino] propanoate and acetic acid. The

reaction mixture was heated at 90‐95oC. Reaction mixture was quenched with water and

extracted with Ethyl acetate. Organic layer was concentrated to give crude solid. Which upon

purification by Ethanol (Denatured with cyclohexane): water. Yielded 1‐Methyl‐2‐[N‐(4‐

cyanophenyl)‐aminomethyl] benzimidazol‐5‐yl‐carboxylic acid‐N‐(2‐pyridyl)‐N‐(2‐

ethoxycarbonylethyl)‐amide.

Stage‐II: Preparation of 1‐Methyl‐2‐[N‐(4‐amidinophenyl)‐aminomethyl]benzimidazol‐5‐yl‐

carboxylic acid‐N‐(2‐pyridyl)‐N‐(2‐ethoxycarbonylethyl)‐amide hydrochloride

HCl gas was purged into the suspension of 1‐Methyl‐2‐[N‐(4‐cyanophenyl)‐

aminomethyl]benzimidazol‐5‐yl‐carboxylic acid‐N‐(2‐pyridyl)‐N‐(2‐ethoxycarbonylethyl)‐amide

and Ethanol (Denatured with cyclohexane) at 25‐35oC. N,N‐Diisoproyl ether was added to

above reaction mixture to isolate imidate ester. Which is dissolved in Ethanol (Denatured with

cyclohexane) and Ammonia gas is purged to the reaction mixture. The crude solid obtained is

purify by 10 % solution of acetone/water followed by stirring with water to yielded 1‐Methyl‐2‐

[N‐(4‐amidinophenyl)‐aminomethyl]benzimidazol‐5‐yl‐carboxylic acid‐N‐(2‐pyridyl)‐N‐(2‐

ethoxycarbonylethyl)‐amide hydrochloride.

2-135

Stage‐III: Preparation of 1‐Methyl‐2‐[N‐[4‐(N‐n‐hexyloxycarbonyl amidino)phenyl]‐amino‐

methyl]benzimidazol‐5‐yl‐carboxylic acid‐N‐(2‐pyridyl)‐N‐(2‐ethoxycarbonylethyl)‐amide

To the suspension of 1‐Methyl‐2‐[N‐(4‐amidinophenyl)‐aminomethyl]benzimidazol‐5‐yl‐

carboxylic acid‐N‐(2‐pyridyl)‐N‐(2‐ethoxycarbonylethyl)‐amide hydrochloride in Acetonitrile and

water. Triethyl amine and n‐Hexylchloroformate is added. The suspected solid obtained is

filtered to yielded crude product, which is purify by reflux with Acetonitrile to yielded 1‐Methyl‐

2‐[N‐[4‐(N‐n‐hexyloxycarbonyl amidino)phenyl]‐amino‐methyl]benzimidazol‐5‐yl‐

carboxylicacid‐N‐(2‐pyridyl)‐N‐(2‐ethoxycarbonylethyl)‐amide.

Stage‐IV: Preparation of 1‐Methyl‐2‐[N‐[4‐(N‐n‐hexyloxycarbonyl amidino)phenyl]‐amino‐

methyl]benzimidazol‐5‐yl‐carboxylic acid‐N‐(2‐pyridyl)‐N‐(2‐ ethoxycarbonylethyl)‐ amide

methane sulfonate (API)

Methane sulfonic acid is added to the solution of 1‐Methyl‐2‐[N‐[4‐(N‐n‐hexyloxycarbonyl

amidino)phenyl]‐amino‐methyl]benzimidazol‐5‐yl‐carboxylicacid‐N‐(2‐pyridyl)‐N‐(2‐

ethoxycarbonyl ethyl)‐amide (Dabigatran Etexilate) in acetone. The salt precipitated is filtered

to yielded 1‐Methyl‐2‐[N‐[4‐(N‐n‐hexyloxycarbonyl amidino)phenyl]‐amino‐

methyl]benzimidazol‐5‐yl‐carboxylic acid‐N‐(2‐pyridyl)‐N‐(2‐ethoxycarbonylethyl)‐amide

mesylate (Dabigatran Etexilate Mesylate, API).

2-136

Chemical Reaction Stage‐I: Preparation of 1‐Methyl‐2‐[N‐(4‐cyanophenyl)‐aminomethyl]benzimidazol‐5‐yl‐ carboxylic acid‐N‐(2‐pyridyl)‐N‐(2‐ethoxycarbonylethyl)‐amide

Stage‐II: Preparation of 1‐Methyl‐2‐[N‐(4‐amidinophenyl)‐aminomethyl] benzimidazol‐5‐yl‐carboxylic acid‐N‐(2‐pyridyl)‐N‐(2‐ethoxycarbonylethyl)‐amide hydrochloride

N NCOOEt

ONH2

NH

CH3

Ethyl acetate, Sodium bicarbonate, Ethanol (Denatured with cyclohexane), Water

N NCOOEt

ON

N

CH3

NH CN

MF = C18H22N4O3

FW = 342.39M F = C27H26N6O3

F W = 482.53M F = C9H8N2O2

F W = 176.17

KSM-I

KSM-II

DABI/I

CN

NH

COOH

Acetic acid,

Toluene, DIPEA

CH3CH3

CH3

Cl

O Pivaloyl chloride

Ethyl 3-[{[3-amino-4-(methylamino)phenyl]carbonyl}(pyridin-2-yl)amino]propanoate N-(cyanophenyl) glycine

1-Methyl-2-[N-(4-cyanophenyl)-aminomethyl]benzimidazol-5-yl-carboxylic acid-N-(2-pyridyl)-N-(2-ethoxycarbonylethyl)-amide

+

MF = C5H9ClOFW = 120.57

CAS No.:212322-56-0 CAS No.:42288-26-6 CAS No.:211915-84-3

CAS No.:3282-30-2

1-Methyl-2-pyrrolidone

N NCOOEt

ON

N

CH3

NH

NH

OEt

Ethanol (Denatured with cyclohexane), HCl (gas)

DABI/II/Imidiate ester

N NCOOEt

ON

N

CH3

NH

NH

NH2

. HClDABI/II

Ethanol (Denatured with cyclohexane)

Ammonia (gas)

. HClDiisopropyl ether,

Ethyl acetate

Acetone, WaterM F = C27H26N6O3

F W = 482.53

DABI/I

1-Methyl-2-[N-(4-cyanophenyl)-aminomethyl]benzimidazol-5-yl-carboxylic acid-N-(2-pyridyl)-N-(2-ethoxycarbonylethyl)-amide

CAS No.:211915-84-3

N NCOOEt

ON

N

CH3

NH CN

M F = C29H32N6O4HClF W = 565.10

M F = C27H29N7O3HClF W = 536.0

Stage-II1-Methyl-2-[N-(4-amidinophenyl)-aminomethyl]benzimidazol-5-yl-carboxylic acid-N-(2-pyridyl)-N-(2-ethoxycarbonylethyl)-amide hydrochloride

2-137

Stage‐III: Preparation of 1‐Methyl‐2‐[N‐[4‐(N‐n‐hexyloxycarbonyl amidino)phenyl]‐amino‐methyl]benzimidazol‐5‐yl‐carboxylic acid‐N‐(2‐pyridyl)‐N‐(2‐ethoxycarbonylethyl)‐amide

Stage‐IV: Preparation of 1‐Methyl‐2‐[N‐[4‐(N‐n‐hexyloxycarbonyl amidino)phenyl]‐amino‐methyl]benzimidazol‐5‐yl‐carboxylic acid‐N‐(2‐pyridyl)‐N‐(2‐ethoxycarbonylethyl)‐amide methane sulfonate

Acetonitrile, Acetone, Water

TriethylamineDABI/III

Cl O CH3

O n-Hexyl chloroformateN NCOOEt

ON

N

CH3

NH

NH

NH2

. HCl

DABI/II

M F = C27H29N7O3HClF W = 536.0

Stage-II1-Methyl-2-[N-(4-amidinophenyl)-aminomethyl]benzimidazol-5-yl-carboxylic acid-N-(2-pyridyl)-N-(2-ethoxycarbonylethyl)-amide hydrochloride

N NCOOEt

ON

N

CH3

NH

NH

NH

O

CH3

O

M F = C7H13O2ClF W = 164.63

CAS No.:6092-54-2

M F = C34H41N7O5

F W = 627.73

Stage-III

1-Methyl-2-[N-(4-(N-n-hexyloxycarbonyl amidino)phenyl)-aminomethyl]benzimidazol-5-yl-carboxylic acid-N-(2-pyridyl)-N-(2-ethoxycarbonylethyl)-amide

CAS No.: 211915-06-09

Acetone

Methane sulfonic acid

SO

OH

CH3

ODABI/IV

DABI/III

M F = C34H41N7O5

F W = 627.73

Stage-III1-Methyl-2-[N-(4-(N-n-hexyloxycarbonyl amidino)phenyl)-aminomethyl]benzimidazol-5-yl-carboxylic acid-N-(2-pyridyl)-N-(2-ethoxycarbonylethyl)-amide

N NCOOEt

ON

N

CH3

NH

NH

NH

O

CH3

O

N NCOOEt

ON

N

CH3

NH

NH

NH

O

CH3

O

M F = CH4O3SF W = 96.10

CAS No.:75-75-2

Stage-IV

1-Methyl-2-[N-(4-(N-n-hexyloxycarbonyl amidino)phenyl)-aminomethyl]benzimidazol-5-yl-carboxylic acid-N-(2-pyridyl)-N-(2-ethoxycarbonylethyl)-amide methane sulfonate

M F = C35H45N7O8SF W = 723.83

CAS No.:872728-81-9CAS No.: 211915-06-09

2-138

Material Balance

Total input Kgs.

Starting Material Product output DABIGATRAN I

Quantity Kgs.

Output details

1.945 KSM I 7.586 Aq. Effluent 2.004 1‐Methyl‐2‐Pyrolidone 0.071 Evaporation loss 1.101 KSM II 0.920 Pivaloyl Chloride 1.278 DIPEA 2.043 Acetic Acid

9.291 Total


Total input


Product output DABIGATRAN II

Quantity Kgs.

Output details

1.634 Stage I 0.654 Aq. Effluent 0.245 Hydrochloride 0.035 Evaporation loss 0.116 Ammonia

1.995 Total


Total input


Product output DABIGATRAN III

Quantity Kgs.

Output details

1.307 Stage II 1.778 Aq. Effluent 0.618 N‐Hexyl Chloroformate 0.022 Evaporation loss 0.986 Triethyl Amine

2.911 Total


Total input


Product output DABIGATRAN

Quantity Kgs.

Output details

1.111 Stage III 0.262 Aq. Effluent 0.153 Methane Sulfonic Acid 0.002 Evaporation loss

1.264 Total

1.000gs 0.264 Total

2-139

52. RIVAROXABAN Manufacturing Process Stage‐I: Preparation of 4‐{4‐[(5S)‐5‐(aminomethyl)‐2‐oxo‐1,3‐oxazolidin‐3‐ yl]phenyl} morpholin‐3‐ one hydrochloride 2‐({(5S)‐2‐oxo‐3‐[4‐(3‐oxomorpholin‐4‐yl)phenyl]‐1,3‐oxazolidin‐5‐ yl} methyl)‐1H‐ isoindole‐ 1,3(2H)‐dione {Stage‐II (Non‐DMF)} is reacted with 40% Aqueous methyl amine in Isopropyl alcohol to give 4‐{4‐[(5S)‐5‐(aminomethyl)‐2‐oxo‐1,3‐oxazolidin‐3‐yl] phenyl} morpholin‐3‐ one which is further reacted with aq. HCl to give 4‐{4‐[(5S)‐5‐(aminomethyl)‐2‐oxo‐1,3‐oxazolidin‐3‐yl]phenyl}morpholin‐3‐ one hydrochloride. Stage‐II: Preparation of 5‐Chloro‐N‐({(5S)‐2‐oxo‐3‐[4‐(3‐oxo‐4‐morpholinyl) phenyl]‐1,3‐ oxazolidin‐5‐yl}methyl)‐2‐thiophene‐carboxamide 5‐Chlorothiophene‐2‐carboxylic acid (RM‐III) is reacted with Oxalyl chloride with catalytic amount of DMF in THF to give 5‐Chlorothiophene‐2‐carboxylchloride which is further reacted with 4‐{4‐[(5S)‐5‐(aminomethyl)‐2‐oxo‐1,3‐oxazolidin‐3‐yl]phenyl}morpholin‐3‐one hydrochloride in presence of sodium acetate in Process water/ sulfolane to give 5‐Chloro‐N‐({(5S)‐2‐oxo‐3‐[4‐(3‐oxo‐4‐morpholinyl)phenyl]‐1,3‐oxazolidin‐5‐yl}methyl)‐2‐thiophene‐carboxamide

Stage‐III: Preparation of 5‐Chloro‐N‐({(5S)‐2‐oxo‐3‐[4‐(3‐oxo‐4‐morpholinyl)phenyl]‐1,3‐ oxazolidin‐5‐yl}methyl)‐2‐thiophene‐carboxamide 5‐Chloro‐N‐({(5S)‐2‐oxo‐3‐[4‐(3‐oxo‐4‐morpholinyl)phenyl]‐1,3‐ oxazolidin‐5‐yl}methyl)‐2‐thiophene‐carboxamide is crystallized from Acetic acid to give Rivaroxaban.

2-140

2-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)-1 H-isoindole-1,3(2 H)-dione

CAS NO:446292-08-6

Mol.For:C22H19N3O6

Mol.Wt:421.40

O

N

O

N

OO

N

O

O

40% Aq. Methyl Amine

IPA

O

N

N

O

O

NH2

O

4-{4-[(5S)-5-(aminomethyl)-2-oxo-

1,3-oxazolidin-3-yl]phenyl}morpholin-3-one.HCl

Mol.For:C14H18N3O4ClMol.Wt:327.8

Stage-II (Non-DMF)Stage-I

HCl

CAS NO:898543-06-1

+ N

O

O

CH3

CAS NO:550-44-7

2-Methyl-1H-isoindole-1,3-(2H)-dioneMol.For:C9H7NO2Mol.wt:161.15

MDC:Methanol

Rivaroxaban

CAS NO:366789-02-8

Mol.For:C19H18ClN3O5S

Mol.Wt:435.88

Stage-III

Acetic acid

CAS NO:366789-02-8

Mol.For:C 19H18ClN3O5S

Mol.Wt:435.88

O

N

O

N

OO

SO

NHCl

Stage-II

5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)

phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophene-carboxamide

O

N

O

N

OO

SO

NHCl

Chemical Reaction Stage‐I: preparation of4‐{4‐[(5S)‐5‐(aminomethyl)‐2‐oxo‐1,3‐oxazolidin‐3‐ yl]phenyl}morpholin‐3‐one hydrochloride Stage‐II: Preparation of 5‐Chloro‐N‐({(5S)‐2‐oxo‐3‐[4‐(3‐oxo‐4‐morpholinyl) phenyl]‐1,3‐ oxazolidin‐5‐yl}methyl)‐2‐thiophene‐carboxamide Stage‐III: Preparation of 5‐Chloro‐N‐({(5S)‐2‐oxo‐3‐[4‐(3‐oxo‐4‐morpholinyl)phenyl]‐1,3‐ oxazolidin‐5‐yl}methyl)‐2‐thiophene‐carboxamide

2-141

Material Balance

Total input Kgs.

Starting Material Product output RIVAROXABAN I

Quantity Kgs.

Output details

1.411 (4‐4‐Aminophenyl)‐morpholin‐3‐one 0.790 Aq. Effluent

1.637 Glycidyl Phthalimide 0.071 Evaporation loss

3.048 Total


Total input


Product output RIVAROXABAN II

Quantity Kgs.

Output details

2.187 Stage I 4.155 Aq. Effluent 0.007

4‐Dimethylaminopyridine(DMAP) 0.109 Solvent Recovery

4.034 CDI

6.228 Total


Total input Kgs.


RIVAROXABAN II A

Quantity Kgs.

Output details

1.968 DMF ST 3.935 Aq. Effluent 1.220 5‐Chlorothiophene‐2‐

cacoxylic acid 0.403 Carbon Dioxide 1.476 Sodium Acetate 1.495 Oxalyl Chloride

6.158 Total


Total input


Product output RIVAROXABAN III

Quantity Kgs.

Output details

1.829 DMF SKSM NDMF‐ST‐II 2.926 Aq. Effluent 1.627 Aq. Methyl Amine 0.064 Evaporation Loss 0.677 Hydrochloric Acid 4.133 Total


Total input


Product output RIVAROXABAN

Quantity Kgs.

Output details

1.143 Stage II 0.114 Aq. Effluent 0.000 0.029 Evaporation Loss

1.143 Total


2-142

53. ASENAPINE Manufacturing Process Stage‐I: Preparation of Trans‐2‐methyl‐5‐nitro‐2,3,3a,12b‐tetrahydro‐1H dibenz[2,3:6,7] oxepino[4,5‐c]‐pyrrole To a solution of Trans‐N‐methyl‐4‐(2‐bromophenyl)‐3‐(2‐hydroxy‐5‐nitrophenyl)‐pyrrolidine in toluene, were added Cesium carbonate, N,N‐Dimethylglycine hydrochloride, N,N‐Dimethylacetamide and Cuprous chloride under Nitrogen purging and refluxed the reaction mixture at 110‐115oC till the completion of reaction. The reaction mixture is cooled, Liq. Ammonia and Process water are added and filtered though Hyflow bed to remove copper salt. Organic layer is collected by layer separation and washed with Process water. Activated carbon is added to organic layer and filtered through Hyflow bed. After distillation of organic layer, the crude is purified by making its fumarate salt in acetone and Fumaric acid. This fumarate salt is cleaved with Liq. Ammonia and water and extracted with dichloromethane. After distillation of organic layer, obtained residue is stirred with Methanol by adding seed crystal of standard Trans‐2‐methyl‐5‐nitro‐2,3,3a,12b‐tetrahydro‐1H‐dibenz[2,3:6,7] oxepino[4,5‐c]‐pyrrole. Water is added and allowed the reaction mixture to stir at 25‐35oC. The obtained solid is filtered and dried to give Trans‐2‐methyl‐5‐nitro‐2,3,3a,12b‐tetrahydro‐1H‐dibenz[2,3:6,7] oxepino[4,5‐c]‐pyrrole.

Stage‐II: Preparation of Trans‐5‐chloro‐2‐methyl‐2,3,3a,12b‐tetrahydro‐1H‐dibenz[2,3:6,7] oxepino[4,5‐c]‐pyrrole maleate (Crude) To a solution of Trans‐2‐methyl‐5‐nitro‐2,3,3a,12b‐tetrahydro‐1H‐dibenz[2,3:6,7] oxepino[4,5‐c]‐pyrrole in Methanol, is added 10% palladium charcoal (50% wet) and hydrogenated under hydrogen pressure (8‐10Kg/cm2) at 25‐35oC till the completion of reaction. The catalyst is removed by filtration through Hyflow and filtrate is distilled out under vacuum to give residue, which is partitioned between dichloromethane and dilute sodium hydroxide. Distillation of organic layer under vacuum yielded Trans‐2‐methyl‐5‐amino‐2,3,3a,12b‐tetrahydro‐1H‐dibenz[2,3:6,7] oxepino[4,5‐c]‐pyrrole as an oil. Dichloromethane is stripped out with Process water from the oil, the oil is taken in conc. Hydrochloric acid and a solution of Sodium nitrite in Process water is added to it at 0‐5oC. (Diazonium solution) Meanwhile a solution of cuprous chloride in conc. Hydrochloric acid is prepared and above diazonium solution is added at 0‐5oC. Reaction mixture is allowed to stir at 20‐25oC till the completion of reaction. Reaction is quenched with simultaneous addition of ethyl acetate and Liq. Ammonia to bring basic pH. Organic layer is separated, stirred with activated carbon and filtered through Hyflow bed. Distillation of organic layer under vacuum gave crude free base, which is purified by column chromatography using 35% ethyl acetate in Cyclohexane as an eluent. The pure free base Trans‐5‐chloro‐2‐methyl‐2,3,3a,12b‐tetrahydro‐1H‐dibenz[2,3:6,7] oxepino[4,5‐c]‐pyrrole is obtained as an oil, which is unloaded in n‐Butyl alcohol for the next reaction. The oil in n‐Butyl alcohol is heated to 60‐65oC after adding activated carbon and filtered through Hyflow bed. This solution is added slowly to previously prepared solution of Maleic acid in n‐Butyl alcohol at 40‐45oC. After maintaining for 30 min. at same temperature, the reaction mixture is cooled gradually to 25‐35oC within 3‐4 hrs and followed by addition of seed crystal of standard Asenapine maleate gave solid. The obtained Asenapine maleate crude is filtered and washed with n‐butyl alcohol and dried.

2-143

M F C17H17BrN2O3

F W 377.23

+ CsCl + CsBr + 2 CsOH

M F ClCsF W 168.35

M F BrCsF W 212.80

M F HCsOF W 149.91

+ 2 CO2

M F CO2

F W 44.00

+

M F C4H9NO2

F W 103.12

CuCl2+

M F Cl2CuF W 134.45

M F C17H16N2O3

F W 296.32

H4NOOC

COONH4

M F C4H10N2O4

F W 150.13

+

CAS No. 14548-85-7

+ 2 H2O

M F H2OF W 18.01

O2N

OH

N

CH3

BrH

H

Cesium carbonate

DMAc, Toluene, Liq. Ammonia, Activated carbon, Fumaric acid, Acetone

ASEP-025/III (KSM)

O

N

O2N

CH3

H H

HOOC

COOH

O

N

O2N

CH3

H H

Liq. Ammonia, Dichloromethane

Methanol, water

ASEP-025/DMF/ITrans-2-methyl-5-nitro-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]-pyrrole fumarate

Trans-2-methyl-5-nitro-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]-pyrrole

Trans-N-methyl-4-(2-bromophenyl)-3-(2-hydroxy-5-nitrophenyl)-pyrrolidine

M F C21H20N2O7

F W 412.39

CAS No. 7647-17-8CAS No. 7787-69-1

CAS No. 21351-79-1CAS No. 1118-68-9 CAS No. 7447-39-4

Cesium chloride Cesium bromide Cesium hydroxide Carbon dioxide Cupric chloride

Ammonium fumarate Water

N,N-Dimethylglycine.HCl

M F CCs2O3

F W 325.82

CAS No. 534-17-8

M F C4H9NO2.HClF W 139.58

CAS No. 2491-06-7Cuprous chloride

M F ClCuF W 98.99

CAS No. 7758-89-6

CAS No. 124-38-9

N

COOHCH3

CH3

N,N-Dimethyglycine

Stage‐III: Preparation of Trans‐5‐chloro‐2‐methyl‐2,3,3a,12b‐tetrahydro‐1H‐dibenz[2,3:6,7] oxepino[4,5‐c]‐pyrrole maleate The crude Trans‐5‐chloro‐2‐methyl‐2,3,3a,12b‐tetrahydro‐1H‐dibenz[2,3:6,7] oxepino[4,5‐c]‐pyrrole maleate is purified by taking it into n‐Butyl alcohol and heated at 60‐70oC till clear or hazy solution. The activated carbon is added and allowed to stir the reaction mixture at same temperature. Carbon is removed by filtration though Hyflow bed and filtrated is allowed to stir at 25‐35oC. The obtained solid is filtered and washed with n‐butyl alcohol and dried to give Asenapine maleate. Chemical Reaction Stage‐I: Preparation of Preparation of Trans‐2‐methyl‐5‐nitro‐2,3,3a,12b‐tetrahydro‐1H‐dibenz[2,3:6,7]oxepino[4,5‐c]‐pyrrole

2-144

O

N

Cl

CH3

H H

COOH

COOH

M F C21H20ClNO5

F W 401.84

ASEP-025/DMF/IITrans-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]-pyrrole maleate (Crude)

O

N

Cl

CH3

H H

COOH

COOH

Activated carbon

n-Butyl alcohol

ASEP-025/DMF/III

M F C21H20ClNO5

F W 401.84

Trans-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]-pyrrole maleate

Stage‐II: Preparation of Trans‐5‐chloro‐2‐methyl‐2,3,3a,12b‐tetrahydro‐1H‐dibenz[2,3:6,7] oxepino[4,5‐c]‐pyrrole maleate (Crude)

Stage‐III: Preparation of Trans‐5‐chloro‐2‐methyl‐2,3,3a,12b‐tetrahydro‐1H‐dibenz[2,3:6,7]oxepino[4,5‐c]‐pyrrole maleate

M F C17H16N2O3

F W 296.32

O

N

O2N

CH3

H H

ASEP-025/DMF/I

Trans-2-methyl-5-nitro-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]-pyrrole

O

N

NH2

CH3

H H

O

N

Cl

CH3

H HMethanol, Sodium hydroxide, Dichloromethane

conc. HClPd/C (10%), H2

Ethyl acetate, Liq. Ammonia, Activated carbonSilica gel, Cyclohexane, Ethyl acetate for Purification by Column chromatography, n-Butyl alcohol

O

N

Cl

CH3

H H

COOH

COOH

n-Butyl alcohol

Activated carbon

M F C17H18N2OF W 266.33

M F C17H16ClNOF W 285.76

ASEP-025/DMF/IIA ASEP-025/DMF/IIB

M F C21H20ClNO5

F W 401.84

ASEP-025/DMF/II

Trans-2-methyl-5-amino-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]-pyrrole

Trans-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]-pyrrole

M F C4H4O4

F W 116.07

CAS No. 110-16-7

Maleic acid

NaNO2

M F NNaO2

F W 68.99

CAS No. 7632-00-0

Cuprous chloride

M F ClCuF W 98.99

CAS No. 7758-89-6

Trans-5-chloro-2-methyl-2,3,3a,12b-tetrahydro-1H-dibenz[2,3:6,7]oxepino[4,5-c]-pyrrole maleate (Crude)

CAS No. 7727-37-9

M F H2OF W 18.01

+ N2

M F N2

F W 28.01

+ NaCl

M F ClNaF W 58.44

+ 5 H2O Cu(OH)2+

M F H2O2CuF W 97.56

CAS No. 7647-14-5 CAS No. 20427-59-2

Nitrogen Sodium chloride Water Cupric hydroxide

NH4Cl+

M F H4ClNF W 53.49

CAS No. 12125-02-9

Ammonium chloride

2-145

Material Balance

Total input Kgs.

Starting Material Product output ASENAPINE‐IA

Quantity Kgs.

Output Details

9.450 CuCI2.(H2O)2 10.112 Aq Effluent 6.899 Sodium Sulphite 1.796 Sulphur Dioxide 0.284 Hydro Chloric Acid

16.632 Total

4.725kgs

11.907 Total

Total input


Product output ASENAPINE‐I

Quantity Kgs.

Output Details

4.725

Trans‐N‐methyl‐4‐(2‐bromophenyl)‐3‐(2‐hydro‐5‐nitrophenyl) 89.114 Aq Effluent

8.159 Cesium Carbonate 1.080 Carbon Dioxide Gas 1.239 Cuprous chloride

1.747 N,N‐Dimethyl glycine hydrochloride

74.716 Ammonium Hydroxide 1.308 Fumic Acid

91.895 Total

1.701kgs

90.194 Total

Total input Kgs.


ASENAPINE Quantity

Kgs. Output Details

1.701 Nitro Oxepine 18.571 NH4OH 32.392 Aq. Effluent

0.034 Hydrogen Gas 1.136 Cuprous Chloride 0.474 Sodium Nitrite

11.020 Hydrochloric Acid 0.456 Maleic Acid

33.392 Total

1.000kgs 32.392 Total

2-146

54. SILOSODINE Manufacturing Process Stage‐I: Preparation of [(3‐Chloropropoxy) methyl] benzene (SC) 3‐Chloro‐1‐propanol, Benzyl bromide and Tertabutylammoniumbromide were taken in Dichloromethane and Sodium hydroxide solution was added to the mass. Then reaction mass was reflux, further organic layer separated and on evaporation of solvent gives [(3‐Chloropropoxy) methyl] benzene. Stage‐II: Preparation of 1‐[3‐(Benzyloxy) propyl]indoline (O‐Benzyl Indo.) Indoline is N‐Alkylated with [(3‐Chloropropoxy) methyl] benzene in presence of Sodium bromide and N,N‐Diisopropylethylamine as base in Dimethyl formamide to give 1‐[3‐(Benzyloxy)propyl]indoline (O‐Benzyl Indo.). Finally the compound is isolated on form of oil from Cyclohexane. Stage‐III: Preparation of 1‐[3‐(Benzyloxy)propyl]indoline‐5‐carbaldehyde (Formyl Indo.) 1‐[3‐(Benzyloxy) propyl]indoline (O‐Benzyl Indo.) is formylated using Dimethylformamide and Phosphorus oxychloride to give 1‐[3‐(Benzyloxy)propyl]indoline‐5‐carbaldehyde (Formyl Indo.). Which on work up and finally on evaporation of organic solvent isolated in form of oil. Stage‐IV: Preparation of 1‐[3‐(Benzyloxy) propyl]‐7‐bromoindoline‐5‐carbaldehyde (Brom. Indo.) 1‐[3‐(Benzyloxy)propyl]indoline‐5‐carbaldehyde (Formyl Indo.) is brominated using liquid bromine in glacial acetic acid to give 1‐[3‐(Benzyloxy)propyl]‐7‐bromoindoline‐5‐carbaldehyde (Brom. Indo.) as oil. Stage‐V: Preparation of 1‐[3‐(Benzyloxy)propyl]‐5‐formylindoline‐7‐carbonitrile (Cyano Aldehyde) Reaction of 1‐[3‐(Benzyloxy)propyl]‐7‐bromoindoline‐5‐carbaldehyde (Brom. Indo.) with Copper (I) Cyanide in Dimethylformamide, further upon work up will give crude 1‐[3‐(Benzyloxy)propyl]‐5‐formyl indoline‐7‐carbonitrile (Cyano Aldehyde). Finally purification of Crude will give pure 1‐[3‐(Benzyloxy)propyl] ‐5‐formyl indoline‐7‐carbonitrile (Cyano Aldehyde).

2-147

Chemical Reaction Stage‐I: Preparation of [(3‐Chloropropoxy)methyl]benzene (SC)

Stage‐II: Preparation of 1‐[3‐(Benzyloxy)propyl]indoline (O‐Benzyl Indo.)

Stage‐III: Preparation of 1‐[3‐(Benzyloxy)propyl]indoline‐5‐carbaldehyde (Formyl Indo.)

Br

+Cl OH

NaOH OCl

Tetra butyl ammonium Bromide

Water

Dichloromethane

MF= C3H7ClO

FW= 94.54 MF= C7H7BrFW= 171.034

MF= C10H13ClO

FW= 184.66

+ NaBr+H2O

Benzyl bromide [(3-Chloropropoxy)methyl]benzene

[CAS No 627-30-5]

[CAS NO 100-39-0][CAS No 26420-79-1 ]

3-chloro-1-propanol

NH

Indoline

+N

O

H5C6

C6H5OCl

Dimethyl formamide

N,N-Diisopropylamine

MF= C10H13ClOFW= 184.662 MF= C18H21NO

FW= 267.365

MF= C8H9NFW= 119.16

[(3-Chloropropoxy)methyl]benzene1-[3-(Benzyloxy)propyl]indoline

NaBr

N

CH3

CH3

CH3 CH3

CH3+ClH

+ NaBr

[CAS No 496-15-1] [CAs No

496-15-1] [CAS No 459868-64-5]

F W= 165.70

N

O

H5C6

N

O

CHO

H5C6

Dimethyl formamide

Phosphrous oxychloride

MF= C18H21NO

FW= 267.365

MF= C19H21NO2

FW= 295.375

1-[3-(Benzyloxy)propyl]indoline 1-[3-(Benzyloxy)propyl]indoline-5-carbaldehyde

[CAS NO 459868-64-5]

[CAS No 459868-63-4]

2-148

Stage‐IV: Preparation of 1‐[3‐(Benzyloxy)propyl]‐7‐bromoindoline‐5‐carbaldehyde (Brom. Indo.)

Stage V : Preparation of 1‐[3‐(Benzyloxy)propyl]‐5‐formylindoline‐7‐carbonitrile (Cyano Aldehyde)

N

O

CHO

H5C6

MF= C19H21NO2

FW= 295.375

Br2

N

O

H5C6

CHO

Br

CH3COOH

MF= C19H20BrNO2

FW= 374.271

1-[3-(Benzyloxy)propyl]indoline-5-carbaldehyde 1-[3-(Benzyloxy)propyl]-7-bromoindoline-5-carbaldehyde

+ BrH + CH3COOH

[CAS NO 459868-63-4]

[CAS No 1375180-28-1]

N

O

CHO

H5C6

Br

CuCN

N

O

H5C6

CHO

CN

Dimethylformamide

MF = C19H20BrNO2

1-[3-(Benzyloxy)propyl]-7-bromoindoline-5-carbaldehyde 1-[3-(Benzyloxy)propyl]-5-formylindoline-7-carbonitrile

MF = C20H20N2O2

+CuBr

[CAS No 1375180-28-1]

[CAS No 1375180-30-5]

F W= 374.2716F W= 320.385

2-149

Material Balance Total input


Product output SILODOSIN I

Quantity Kgs.

Output details

1.000 3‐Chloropropano 3.344 Aq. Effluent 1.664 Benzyl Bromide 0.020 Carbon Dioxide 0.000 TBAB 2.650 Sodium Hydroxide

5.314 Total


Total input


Product output SILODOSIN II

Quantity Kgs.

Output details

1.000 Indoline 1.620 Aq. Effluent 1.860 Stage I 0.003 Evaporation loss 0.863 Sodium Bromide

3.723 Total

2.100kgs

1.623 Total

Total input Kgs.

Starting Material Product output SILODOSIN III

Quantity Kgs.

Output details

270.000 Stage II 2057.000 Aq. Effluent 321.300 POCI3 0.940 Evaporation loss 383.940 DMF

1350.000 Water

2325.240 Total

267.30kgs 2057.940 Total

Total input


Product output SILODOSIN IV

Quantity Kgs.

Output details

1.000 Stage III 0.540 Aq. Effluent 0.590 Bromide 0.020 Evaporation loss

1.590 Total

1.030kgs

0.560 Total

Total input


Product output SILODOSIN IV‐A

Quantity Kgs.

Output details

1.000 Hydrogen Bromide 4.100 Aq. Effluent 0.130 Sodium meta Bisulphate 4.000 Water

5.130 Total


Total input


Product output SILODOSIN V

Quantity Kgs.

Output details

1.000 Stage IV 0.640 Aq. Effluent 0.240 Copper Cyanide

1.240 Total

0.640kgs

0.640 Total

2-150

55. ZOLMITRIPTAN Manufacturing Process Reduction of (S)‐4‐(4‐Nitrobenzyl)‐1,3‐oxazolidin‐2‐one to give (S)‐4‐(4‐Aminobenzyl)‐1,3‐oxazolidin‐2‐one hydrochloride,and diazotization using sodium nitrite to form KSM ((S)‐aminobenzyl 1,3‐oxazolidinone‐2‐one hydrochloride salt), water and acid is reacted with N,N‐dimethyl butanal diethylacetal under heating to form Zolmitriptan base salt, which was then basified and extracted in ethyl acetate to isolate crude Zolmitriptan base and crystallized in isopropyl alcohol to get pure Zolmitriptan Chemical Reaction

2-151

Material Balance

Total input Kgs.


ZOLMITRIPTAN I Quantity

Kgs. Output Details

1.754 (S)‐4‐(4‐Amino Benzyl)‐1,3‐Oxazolidin 2‐One 2.202 Aq. Effluent

0.661 Sodium Nitrite 0.579 Sulphur Dioxide Gas 0.460 Sodium Sulphite 1.796 Hydrochloric Acid

4.672 Total


Total input


Product output ZOLMITRIPTAN

Quantity Kgs.

Output Details

1.891 (S)‐4‐(4‐Hydrazinyl Benzyl)‐1,3‐Oxazolidin 2‐One 2.040 Aq. Effluent

1.728 4‐Dimethylamino Butanal Diethyl Acetate 0.421 Solvent Recovery

0.158 Ammonia Gas 3.619 Total


2-152

56. ILOPERIDONE Manufacturing Process Reaction of 1‐(4‐hydroxy‐3‐methoxyphenyl) ethanone with 1‐bromo‐3‐chloropropane in presence of potassium carbonate gives 1‐[4‐(3‐chloropropoxy)‐3‐methoxyphenyl] ethanone. Condensation of 1‐[4‐(3‐chloropropoxy)‐3‐methoxyphenyl]ethanone with 6‐fluoro‐3(4‐piperidinyl)‐1,2‐benzisoxazole hydrochloride in presence of potassium carbonate gives crude Iloperidone. Iloperidone crude is the treated with Tartaric acid to produce Tartarate salt of Iloperidone, which on basification with ammonia to furnish pure Iloperidone. Chemical Reaction

2-153

Material Balance

Total input Kgs.

Starting Material Product output ILOPERIDONE I

Quantity Kgs.

Output details

0.549 4‐Methoxy‐3‐hydroxy Acetophenone 1.208 Aq. Effluent

1.044 1‐Bromo‐3‐Chloropropane 0.055 Evaporation loss 0.457 Potassium Carbonate 0.073 Carbon Dioxide

2.050 Total


Total input


Product output ILOPERIDONE II

Quantity Kgs.

Output details

0.714 Stage I 1.150 Aq. Effluent 0.756 6‐Fluoro‐3‐(4‐piperidinyl)‐

1,2‐benzisoxazole hydrochloride 0.131 Carbon Dioxide

0.508 Potassium Carbonate 0.303 Sodium Bromide

2.281 Total

1.000kgs

1.281 Total

Total input


Product output ILOPERIDONE

Quantity Kgs.

Output details

1.000 Iloperidone Solvent Recovery Methanol

1.000 Total


2-154

57. AGOMELATINE Manufacturing Process Catalytic hydrogenation of (7‐Methoxy‐1‐naphthyl) acetonitrile using Methanol and Ammonia gives 2‐(7‐Methoxy‐1‐naphthyl) ethanamine. Condensation of 2‐(7‐Methoxy‐1‐naphthyl) ethanamine with acetyl chloride in presence of base gives crude Agolelatine. Which on purification gives final Agomelatine API. Reaction Balance

2-155

Material Balance

Total input Kgs.


AGOMEALTINE‐I Quantity

Kgs. Output details

1.000 2‐(7‐methoxy‐1‐napthyl) Acetonitrile/ Agomelatine

0.020 Hydrogen Gas 0.560 Isopropyl Alcohol Recovery 0.740 Isopropyl Alcohol HCL 0.100 Isopropyl Alcohol Recovery Loss

0.020 Evaporation Loss

1.760 Total

1.08kgd 1.760 Total

Total input Kgs.

Starting Material Product output AGOMEALTINE

Quantity Kgs.

Output details

1.000 2‐(7‐methoxy ‐1‐napthyl)ethylamine hydrochloride

0.420 Sodium Acetate Anhydrous 0.500 Acetic Acid 0.510 Acetic Anhydrous 0.620 Sodium Chloride

1.930 Total


2-156

58. TICAGRELOR Manufacturing Process Condensation of 2‐[(1S,2R,3S,4R)‐4‐amino2,3‐[(1‐methylethylidene)dioxy]‐1‐cyclopentoxy]ethanol with 4,6‐dichloro‐2‐(propylthio)‐5‐pyrimidinamine in presence triethylamine in methanol as solvent gives 2‐[(1S,2R,3S,4R)‐4‐[[‐amino‐4‐chloro‐2‐(propylthio)‐6‐pyrimidinyl]amino]‐2,3‐[(1‐methylethylidene)dioxy] cyclopentoxy]ethanol. (Stage‐I). Reaction of Stage I with sodium nitrite and acetic acid gives 2‐[(1S,2R,3S,4R)‐4‐[7‐chloro‐5‐(propylthio)‐3H‐{1,2,3}triazolo[4,5‐d]pyrimidin‐3‐yl]‐2,3‐[(1‐methylethylidene) dioxy]‐1‐cyclopentoxy]ethanol.(Stage‐II). Reaction of Stage II with (1R,2S)‐2‐(3,4‐difluorophenyl)cyclopropanaminium(R)‐2‐hydroxy‐2‐phenylacetate in presence of triethylamine with acetonitrile as solvent gives . 2‐[(1S,2R,3S,4R)‐4‐[7‐[[(1R,2S)‐2‐(3,4‐difluorophenyl) cyclopropyl] amino]‐5‐(propylthio)‐3H‐[1,2,3]triazolo[4,5‐d]pyrimidine‐3‐yl]‐2,3‐[(1‐methylethylidene) dioxy‐1 cyclopentoxy]ethanol. (Stage III). Stage III on hydrolysis with hydrochloric acid in methanol as solvent gives Ticagrelor. 2‐{(3aR,4S,6S,6aS)‐6amino2,2 dimethyl tetrahydo‐3aH‐cyclopenta[d][1,3]dioxol‐4‐yl)oxy}ethanol L‐tartaric acid is reacted with 4,6‐Dichloro‐2‐(propylthio)pyrimidin‐5‐amine in the presence of DIPEA in Sulfolane gives stage‐I. Stage‐I is reacted with sodium nitrite to form triazole compound, which is further reacted with (1R,2S)‐2‐(3,4‐Diflurophenyl)cyclopropanamine tartarate salt in the presence of DIPEA in MDC getg stage‐II. This stage II is reacted with Conc.HCl and methanol to get the title compound Ticagrelor. Chemical Reaction

O O

CH3

CH3

O

OH

NH2O

OH OH

OH

O

OH

.N

N S

CH3

Cl

Cl

NH2

O O

CH3

CH3

O

OH

NH

N

N S

CH3

Cl

NH2

O O

CH3

CH3

O

OH

N

N

N S

CH3

NH

N

NF

F

OH OH

O

OH

N

N

N S

CH3

NH

N

NF

F

+Sulfolane

Diisopropylethylamine

KSM - I KSM - IIStage - I

O O

CH3

CH3

O

OH

NH

N

N S

CH3

Cl

NH2

Stage - I

O O

CH3

CH3

O

OH

N

N

N S

CH3

Cl

N

N

Stage - IIA

Sodium nirite

Oxalic acid dihydrate

THF

.Tartrate

Stage - II

Conc.HCl

Methanol

Stage - III

NH2

F

F

KSM - III

Ticagrelor

EthylacetateCyclohexane

Diisopropylethylamine

+O

OH OH

OH

O

OH

Tartaric acid

+HCl

Hydrochloric acid

Methylene chloride

2-157

Material Balance

Total input Kgs.

Starting Material Product output TICAGRELOR I

Quantity Kgs.

Output details

1.985 KSM‐I 3.633 Aq. Effluent 1.489 KSM‐II 0.040 Hydrogen Gas 2.085 DIPEA

5.559 Total


Total input Kgs.

Starting Material Product output TICAGRELOR II

Quantity Kgs.

Output details

1.886 Stage I 1.018 Aq. Effluent 0.506 Sodium Nitrite 0.189 Solvent recovery 0.381 Potassium Carbonate 0.092 Carbon Dioxide Gas

2.773 Total


Total input Kgs.

Starting Material Product output TICAGRELOR III

Quantity Kgs.

Output details

1.471 Stage II 1.668 Aq. Effluent 0.376 Sodium Hydroxide 0.129 Solvent recovery 0.953 Hydrochloric Acid 0.002 Carbon Dioxide Gas

2.799 Total


2-158

59. METAXALON Manufacturing Process Stage‐I: Preparation of 2‐[(3,5‐Dimethylphenoxy)methyl]oxirane A mixture of 3,5‐Dimethylphenol and Epichlorohydrine is stirred with aqueous Potasssium hydroxide at 40oC. Water is distilled out under vacuum after the reaciton. The liquid crude product 2‐[(3,5‐Dimethylphenoxy)methyl]oxirane obtained is taken as such for the next reaction. Stage‐II: Preparation of 5‐[(3,5‐dimethylphenoxy)methyl]‐1,3‐oxazolidin‐2‐one (Metaxalone) To a solution of 2‐[(3,5‐Dimethylphenoxy)methyl]oxirane in N,N‐Dimethylformamide, is added Ethylcarbamate and catalytic amount of Triethylamine. The reaction mixture is heated at 120‐125oC till the completion of the reaction. After the reaction, isolated solid is filtered once, which is purified by stirring with isopropyl alcohol to get 5‐[(3,5‐dimethylphenoxy)methyl]‐1,3‐oxazolidin‐2‐one (Metaxalone). Chemical Reaction Stage‐I: Preparation of 2‐[(3,5‐Dimethylphenoxy)methyl] oxirane

Stage‐II: Stage‐II: Preparation of 5‐[(3,5‐dimethylphenoxy)methyl]‐1,3‐oxazolidin‐2‐one (Metaxalone)

OHCH3

CH3

+O

Cl aq. KOH

OCH3

CH3

O

META/St-I

3,5-Dimethylphenol Epichlorohydrin 2-[(3,5-Dimethylphenoxy)methyl]oxirane

MF = C8H10OFW = 122.16

MF = C3H5ClOFW = 92.52

MF = C11H14O2

FW = 178.22

+ K Cl

Potassium chloride

+ H2O

MF = ClKFW = 74.55

DMF, TEA, Isopropyl alchol

OCH3

CH3

O

NH

O

Metaxalone

META/St-II

5-[(3,5-Dimethylphenoxy)methyl]-1,3-oxazolidin-2-one

MF = C12H15NO3

FW = 221.25

NH2 COOEt

Ethyl carbamate

MF = C3H7NO2

FW = 89.09OCH3

CH3

O

META/St-I2-[(3,5-Dimethylphenoxy)methyl]oxirane

MF = C11H14O2

FW = 178.22

+ CH3CH2OH

+ N C2H5

H5C2

H5C2

Triethylamine

MF = C6H15NFW = 101.19

MF = C2H6OFW = 46.06

Ethanol

2-159

Material Balance

Total input Kgs.

Starting Material Product output METAXALONE I

Quantity Kgs.

Output details

1.840 3,5‐Dimethylphenol 2.631 Aq. Effluent 1.393 Epichlorohydrine 0.006 Evaporation loss 1.014 Aq. Potassium Hydroxide

4.247 Total


Total input Kgs.

Starting Material Product output METAXALONE

Quantity Kgs.

Output details

1.610 Stage‐I 1.578 Aq. Effluent 0.805 Ethyl carbamate 0.015 Evaporation loss 0.177 Triethyl Amine

2.593 Total


2-160

60. VILAZODONE HYDROCHLORIDE Manufacturing Process Stage‐I: Preparation of stage‐I(1‐(2‐Ethoxycarbonyl benzofuran‐5‐yl) piperazine dihydro chloride monohydrate) Ethyl‐5‐nitro benzofuran‐2‐carboxylate is reduced over 10% Pd/C (50%wet) in the presence of Hydrogen gas in Ethylacetate, which after catalyst filtration and distillation reacted with Bis.HCl in o‐Xylene in the presence of Potassium carbonate powder and TBAB catalyst. The isolation was done by filtration, extraction with MDC and hydrochloride salt formation, distillation and slurried in denatured Ethanol provides stage‐I. Stage‐II: Preparation of stage‐II (1‐[4‐(5‐Cyanoindol‐3‐yl) butyl]‐4‐(2‐ethoxycarbonyl benzofuran‐5‐yl) piperazine hydrochloride) 1‐(2‐Ethoxycarbonyl benzofuran‐5‐yl) piperazine dihydrochloride monohydrate is reacted with KRM‐II in TEA in the presence of TBAB catalyst, after distillation, extracted with MDC followed by distillation, the product was isolated from Acetone‐ IPA.HCl. Stage‐III: Preparation of stage‐III (Vilazodone) The amide formation done by Ammonia gas pressure in autoclave in DMSO, after activated carbon treatment the product isolated from DMSO‐water mix. The crude further purified in DMF‐water mix followed by DMSO‐water treatment. Stage‐IV: Preparation of stage‐IV(Vilazodone hydrochloride) The hydrochloride formation and amorphous form conversion done in Formic acid and Conc. HCl using spray dryer.

2-161

Chemical Reaction Stage‐I: Preparation of Stage‐I

Stage‐II: Preparation of Stage‐II

2-162

Stage‐III: Preparation of Stage‐III

Stage‐IV: Preparation of Stage‐IV

2-163

Material Balance

Total input Kgs.


VILAZODONE.HCl‐1A Quantity

Kgs. Output details

0.726 5‐Nitrosalicyladehyd 1.851 Aq. Effluent 1.249 Dimethyl Bromo Malonate 0.189 Carbon Dioxide

0.900 Potassium Carbonate Power

2.875 Total

0.835kgs

2.040 Total

Total input


Product output VILAZODONE.HCl‐1

Quantity Kgs.

Output details

0.835 Diethyl Bromo Malonate 1.577 Aq. Effluent 0.025 Hydrogen Gas 0.025 Evaporation loss

0.950 Bis(2‐Chloroethyl)Amine HCl 0.075 Carbon Dioxide

0.910 Potassium Carbonate Powder

2.721 Total

1.044kgs

1.677 Total

Total input Kgs.


VILAZODONE.HCl‐IIA

Quantity Kgs.

Output details

1.044 Stage I 3.247 Aq. Effluent 0.668 4‐Chloro‐N,N,2‐Tri‐Methyl‐

7‐Quinolinamine 0.042 Evaporation loss 3.028 Trimethyl Amine 0.115 TBAB

4.855 Total

1.566kgs

3.289 Total

Total input Kgs.


VILAZODONE.HCl‐II

Quantity Kgs.

Output details

1.566 Stage IIA 0.141 Solvent Recovery 0.110 Ammonia 0.360 Aq. Effluent

0.031 Evaporation loss

1.675 Total

1.143kgs

0.532 Total

Total input


Product output VILAZODONE.HCl

Quantity Kgs.

Output details

1.143 Vilazodone (Stage II) 0.206 Aq. Effluent 0.091 Hydrogen Chloride 0.029 Evaporation loss

1.234 Total


2-164

61. TERIFLUNOMIDE Manufacturing Process Stage‐I:‐2‐Cyano‐N‐[4‐(trifluoromethyl) phenyl] acetamide. Cyano acetic acid on reaction with Phosphorous pentachloride in tetrahydrofuran gives corresponding cyanoacetylchloride, which on condensation with 4‐(trifluoromethyl) aniline at 5‐30oC for 3‐4 hrs gives 2‐Cyano‐N‐[4‐(trifluoromethyl) phenyl] acetamide. 2‐Cyano ‐N‐[4‐(trifluoromethyl) phenyl] acetamide is purified using cyclohexane‐isopropanol slurry wash. Stage‐II: ‐ 2‐Cyano‐3‐hydroxy‐N‐[4‐(trifluoromethyl) phenyl] but‐2‐enamide (crude). Acetylation of 2‐Cyano‐N‐[4‐(trifluoromethyl) phenyl] acetamide (stage‐I) using Isopropenyl acetate as acetylating agent and sodium hydroxide as base in Dimethylformamide as solvent at 15‐550C for 4‐5 hrs gives crude 2‐Cyano‐3‐hydroxy‐N‐[4‐(trifluoromethyl) phenyl] but‐2‐enamide. 2‐Cyano‐3‐hydroxy‐N‐[4‐(trifluoromethyl) phenyl] but‐2‐enamide is purified by acid‐base purification using sodium hydroxide and hydrochloric acid to give 2‐Cyano‐3‐hydroxy‐N‐[4‐(trifluoromethyl) phenyl] but‐2‐enamide stage‐II(crude).

Stage‐III: ‐ 2‐Cyano‐3‐hydroxy‐N‐[4‐(trifluoromethyl) phenyl] but‐2‐enamide (Pure). 2‐Cyano‐3‐hydroxy‐N‐[4‐(trifluoromethyl) phenyl] but‐2‐enamide stage‐II (crude) crystallize in Acetonitrile at reflux temperature for 1‐2 hrs to give 2‐Cyano‐3‐hydroxy‐N‐[4‐(trifluoromethyl) phenyl] but‐2‐enamide (pure).

2-165

Chemical Reaction Stage‐I: Preparation of 2 –Cyano‐ N‐[4‐(trifluoromethyl) phenyl] acetamide.

Stage‐II: Preparation of 2‐Cyano‐3‐hydroxy‐N‐[4‐(trifluoromethyl) phenyl] but‐2‐enamide (Crude).

NC

OH

O

Cyanoacetic acidMF C3H3NO2

FW 85.06CAS No 372-09-8

+

FF

F

NH2

4-(Trifluoromethyl)anilineMF C7H6F3NFW 161.12CAS No455-14-1

FF

F

NHCN

O 2-Cyano-N-[4-(trifluoromethyl)phenyl]acetamide Stage-I

MF C10H7F3N2O

FW 228.17

CAS No 87853-82-5

Tetrahydrofuran MF C4H8O FW 72.11 CAS No 109-99-9

+ +

Phosphorus oxychloride

MF POCl3

FW 153.33

CAS No 10025-87-3

2 Hydrochloric acid

MF HCl

FW 36.5

CAS No 7647-01-0

Phosphorous pentachloride MF PCl5 FW 208.24 CAS No 10026-13-8

Isopropanol MF C3H8O FW 60.18 CAS No 67-63-0

Cyclohexane MF C6H12 FW 84.16 CAS No 110-82-7

F F

F

NH

CN

O

Dimethylformamide

MF C3H7NO FW 73.09 CAS No 68-12-2

F

F

F

NH

CH3

OHNC

O

2-Cyano-3-hydroxy-N-

[4-(trifluoromethyl) phenyl]but-2-enamide (Crude) Stage-II

MF C12H9F3N2O2

FW 270.2

CAS No 163451-81-8

Aq. Sodium hydroxide

Conc.hydrochloric acid

MF HCl

FW 36.5

CAS No 7647-01-0

F

F

F

NH

CH3

OHNC

O

2-Cyano-3-hydroxy-N

-[4-(trifluoromethyl)phenyl]but-2-enamide (Crude) Stage-II

MF C12H9F3N2O2

FW 270.2

CAS No 163451-81-8

Water

MF H2O

FW 18.01

CAS No 7732-18-5

+

Acetone

MF C3H6O

FW 58.08

CAS No 67-64-1

+

Sodium chloride

MF NaCl

FW 58.44

CAS No 7647-14-5

+

2-Cyano-N-[4-(trifluoro

methyl)

phenyl]acetamide

Stage-I

MF C10H7F3N2O

FW 228.17

CAS No 87853-82-5

Sodium hydroxide

MF NaOH

FW 39.99

CAS NO 1310-73-2

Isopropenylacetate

MF C5H8O2

FW 100.12

CAS No 108-22-5

2-166

Stage‐III: Purification of 2‐Cyano‐3‐hydroxy‐N‐[4‐(trifluoromethyl) phenyl] but‐2‐enamide (Pure).

Material Balance

Total input Kgs.


TERIFLUNAMIDE I Quantity

Kgs. Output details

1.291 4‐(Trifluoromethyl)Aniline 2.879 Aq. Effluent 0.800 Cyano Acetic Acid 0.039 Evaporation loss 1.962 PCI5

4.053 Total


Total input Kgs.


TERIFLUNAMIDE II

Quantity Kgs.

Output details

1.136 2‐Cyano‐N‐[4‐(Trifluoromethyl)phenyl]Acvetamide 2.877 Aq. Effluent

0.735 Sodium Hydroxide 0.027 Evaporation loss 0.897 Isopropenyl hydroxide 1.136 Hydrochloric Acid

3.904 Total


FF

F

NH CH3

OH

CN

O

2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2- enamide Stage-II

MF C12H9F3N2O2

FW 270.2

CAS No 163451-81-8

Acetonitrile MF C2H3N FW 43.05 CAS No 75-05-8

FF

F

NH CH3

OH

CN

O

2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2- enamide Stage-III

MF C12H9F3N2O2

FW 270.2

CAS No 163451-81-8

Isopropanol MF C3H8O FW 60.1 CAS No 67-63-0

2-167

62. NISOLDIPINE Manufacturing Process 2‐nitro benzaldeyde is condensed with Isobutylacetoacetate in presence of Formic acid and Piperidine at 40‐45°C to give Monoisobutyl ester. Monoisobutyl ester is reacted with 3‐amino crotonic acid methyl ester in presence of 4‐Dimethyl amino pyridine at 80‐85°C to give Nisoldipine Crude. Nisoldipine Crude is purified in the mixture of Acetone: Water to give Nisoldipine. Chemical Reaction

2-168

Material Balance

Total input Kgs.

Starting Material Product output NISOLDIPINE I

Quantity Kgs.

Output details

0.625 2‐Nitrobenzaldehyde 0.041 Aq. Effluent 0.620 Isobutyl Acetoacetate 1.245 Total


Total input Kgs.


NISOLDIPINE Quantity

Kgs. Output details

1.204 2‐Nitrobenzylidine Aceto acetic acid Isobutyl Ester 0.906 Aq. Effluent

0.714 Methyl‐3‐Amino Crotonate 0.013 Evaporation loss

1.919 Total

1.000kgs

0.919 Total

2-169

63. FESOTERODINE FUMARATE Manufacturing Process FESOTERODINE NDMF Stage‐I: Preparation of FES/KSM/I (Ester): Reaction of Cinnamic acid with p‐Cresol in presence of Sulphuric acid gives Coumarin intermediate which on further reaction with Benzyl bromide in presence of Methanol and base gives Ester is isolated from Methanol. Stage‐II: Preparation FES/KSM/II (Amide): Ester is hydrolyzed using Potassium hydroxide and Methanol to give Acid intermediate which on further reaction with Thionyl chloride followed by reaction with Diisopropylamine gives amide. Amide is isolated from Isopropanol. Stage‐III: Preparation of FES/KSM/III (KSM): Amide on reduction with Sodium Borohydride and Borontrifluoride etherate gives Amine (Oil) having one chiral carbon and it is racemic. Racemic Amine (Oil) on resolution with optically active acid Di p‐toluoyl L‐tartaric acid followed by crystallizations gives KSM of desired optical and chemical purity. Chemical Reaction Stage‐I: Preparation of FES/KSM/I (Ester):

Stage‐II: Preparation of FES/KSM/II (Amide):

O

OH

+

OH

CH3Trans-Cinnamic AcidMol.Wt.: 148.11Mol.Formula: C9H8O2

p-CresolMol.Wt.: 108.11Mol.Formula: C7H8O

Toluene

O O

CH3

KSM/Coumarin INSITU]Mol.Wt.: 238.28Mol.Formula: C16H14O2

125 -130°C

Methanol/Acetone

60-65°C

O

OCH3

O

CH3

H2SO4 BnBrAnhy. K2CO3

FES/KSM/I (Ester)Mol.Wt.: 360.44Mol.Formula: C24H24O3CAS NO 40546-94-9

CAS No 106-44-5CAS No 140-10-3

CAS No 854306-67-5

O

OH

O

CH3

KSM/Acid (Insitu)Mol.Wt.: 346.41Mol.Formula: C23H22O3

O

O

O

CH3 CH3

Potassium Hydroxide O

O

CH3Cl

KSM/Acid Chloride [ INSITU]Mol.Wt.: 364.86Mol.Formula: C23H21ClO2

O

O

CH3

N

CH3CH3

CH3

CH3

FES/KSM/II (Amide)Mol.Wt.: 429.59Mol.Formula: C29H35NO2

Thionyl chloride Di Isopropyl Amine

IPA

TolueneToluene

Methanol,

Dichloromethane

FES/KSM/I (Ester)Mol.Wt.: 360.44Mol.Formula: C24H24O3

CAS No 854306-67-5

2-170

Stage‐III: Preparation of FES/KSM/III:

O

O

CH3

N

CH3CH3

CH3

CH3

Amide FES/KSM/II]Mol.Wt.: 429.59Mol.Formula: C29H35NO2

O

CH3

N

CH3CH3

CH3

CH3

Amine FES/KSM/Amine]Mol.Wt.: 415.61Mol.Formula: C29H37NO

35-40°C

Aq. HCl, MDC

NaBH4BF3etherate DPTT

IPA:Water

O

CH3

N

CH3CH3

CH3

CH3

OH

OH

O

O

O

O

CH3

CH3

O

O

FES/KSM/IIIMol.Wt.: 801.96Mol.Formula: C49H55NO9

CAS NO 1308286-12-5CAS NO 389068-22-8

2-171

Manufacturing Process FESOTERODINE DMF Stage‐I: Preparation of Benzylated hydroxy compound Benzylamine DPTT (KSM) oxidizes with Ceric Ammonium nitrate in aqueous Acetonitrile to aldehyde intermediate which on further insitu reduction with Sodiumborohydride gives Benzylated hydroxyl compound as oil. Finally Benzylated hydroxyl compound is isolated as a Fumarate salt from Dichloromethane. Stage‐II: Preparation of Dihydroxy compound Benzylated hydroxyl Fumarate compound converted to free base and debenzylated in Methanol with Hydrogen(g) over Raney Nickel in an autoclave. After completion of reaction catalyst isolated and mass concentrated under vacuum. Dihydroxy compound is isolated from Ethyl acetate. Stage‐III: Preparation of Fesoterodine Fumarate Dihydroxy compound is acylated using Isobutyryl chloride in presence of Triethylamine in Dichloromethane to give Fesoterodine base. Which is insitu converted to its Fumarate salt in Methyl ethyl ketone and Fumaric acid. Further Fumarate salt is isolated by addition of Cyclohexane. Stage‐IV: Purification of Fesoterodine Fumarate Fesoterodine Fumarate dissolved in Methylethylketone and Cyclohexane is added to it. Solid precipitated filtered and dried.

2-172

Chemical Reaction Stage‐I: Preparation of Benzylated hydroxy compound

N CH3

CH3

CH3CH3

CH3

O O

O

OH

OH

O

O

O

O

CH3

CH3

Na2CO3Dichloromethane

N CH3

CH3

CH3CH3

CH3

O

Molecular Formula = C49H55NO9

Formula Weight = 801.9623

Molecular Formula = C29H37NO


Benzylamine DPTT salt (KSM) KSM Free Base (Insitu)

CAS NO 1308286-12-5

N CH3

CH3

CH3CH3

CH3

O

(NH4)2Ce(NO3)6

Acetonitrile/Water

N CH3

CH3

CH3CH3O

O

Molecular Formula = C29H37NO


KSM Free Base (Insitu) Stage IA (insitu)



N CH3

CH3

CH3CH3O

O Dichloromethane

NaBH4Acetonitrile/Water

N CH3

CH3

CH3CH3O

OH

Stage IA (insitu)





Stage IB (insitu)

CAS No 156755-37-2

2-173

Stage‐II: Preparation of Dihydroxy compound

N CH3

CH3

CH3CH3O

OH

Dichloromethane

N CH3

CH3

CH3CH3O

OH

Stage IB (insitu)

Fumaric acid



Stage I

COOH

HOOC



CAS No. 156755-37-2

N

CH3CH3

CH3

CH3

O

OH

HOOC

COOH Na2CO3

Dichloromethane N

CH3CH3

CH3

CH3

O

OH



+

NaOOC

COONa

+

Benzylated hydroxy free Base (insitu)Stage I


Formula Weight = 431.60958CAS No. 156755-37-2

Molecular Formula = C4H2Na2O4


O

O

Molecular Formula = CO2


N

CH3CH3

CH3

CH3

O

OH

Raney NiMethanol

Ethyl acetate

N

CH3CH3

CH3

CH3

OH

OH



+

CH3



Benzylated hydroxy free Base (insitu)

Toluene

Molecular Formula = C7H8


CAS No. 207679-81-0

CAS No. 156755-37-2

H2 (gas)

2-174

Stage‐III: Preparation of Fesoterodine Fumarate

Stage‐IV: Purification of Fesoterodine Fumarate

N

CH3CH3

CH3

CH3OH

OH

N

CH3CH3

CH3

CH3OH

O

CH3

CH3

O

+CH3

CH3Cl

O

DichloromethaneTEA

+N

CH3

CH3

CH3

ClH



Stage II


Molecular Formula = C4H7ClO


Molecular Formula = C6H16ClN

Fesoterodine Base (insitu)



CAS No. 207679-81-0 CAS No. 280930-02-7

N

CH3CH3

CH3

CH3OH

O

CH3

CH3

O

COOH

HOOC

Fumaric acidEthyl methyl ketoneCyclohexane



N

CH3CH3

CH3

CH3OH

O

CH3

CH3

O

Stage III



Fesoterodine Base (insitu)

CAS No. 280930-02-7 CAS No. 280930-03-8

N

CH3CH3

CH3

CH3OH

O

CH3

CH3

O

COOH

HOOC

Ethyl methyl ketoneCyclohexane



N

CH3CH3

CH3

CH3OH

O

CH3

CH3

O

COOH

HOOC



2-175

Material Balance

Total input Kgs.

Starting Material Product output FESOTERODINE

0A

Quantity Kgs.

Output details

5.454 Benzyl amine DPTT 3.054 Aq. Effluent 4.090 Sodium carbonate 3.381 Evaporation loss


9.544 Total


Total input Kgs.


FESOTERODINE I A

Quantity Kgs.

Output details

2.836 Benzyl amine (Free base) 11.998 Aq. Effluent 0.109 Water 0.545 Evaporation loss

12.544 Cerric Ammonium nitrate

15.489 Total

2.945kgs 12.544 Total

Total input Kgs.


FESOTERODINE I B

Quantity Kgs.

Output details

2.945 Stage I A 0.709 Aq. Effluent 0.774 NaBH4 0.065 Evaporation loss

3.719 Total


Total input


Product output FESOTERODINE I

Quantity Kgs.

Output details

2.945 Stage I B 0.763 Aq. Effluent 1.130 Fumic Acid 0.040 Evaporation loss

4.075 Total


2-176

Total input Kgs.

Starting Material Product output FESOTERODINE

Inst

Quantity Kgs.

Output details

3.272 Stage I 1.047 Aq. Effluent 1.636 Sodium Carbonate 0.262 Carbon Dioxide

1.014 Evaporation loss

4.908 Total


Total input


Product output FESOTERODINE II

Quantity Kgs.

Output details

2.585 Benzylated Free Base(Inst) 1.017 Aq. Effluent 0.013 Hydrogen gas 0.565 evaporation loss

2.599 Total


Total input Kgs.


FESOTERODINE III A

Quantity Kgs.

Output details

1.017 Dihydroxy Compound 0.407 Aq. Effluent 0.340 Isobutyryl chloride 0.020 evaporation loss 0.301 Triethylamine

1.657 Total


Total input


Product output FESOTERODINE

Quantity Kgs.

Output details

1.230 Fesoterodine Base(Inst) 0.577 Aq. Effluent 0.347 Fumaric Acid

1.577 Total


2-177

+ NaHCO3

MDCN NH2

CHO

Cl

2-Amino PyridineChloroacetaldehyde +

N

N

Stage-I

Ethyloxalyl chloride

Toluene

N

N

O

O

CH3

O

N

N

OH

O

Stage-II

Hydrazine hydrateKOH, water

EtOAc.HCl

.HCl

N

N

OH

OO

+ N2

N

N

OH

O

Stage-II

.HCl

Phosphorous acid

Phosphorous trichloride

Tetramethylurea

N

N

PPOH

OOOH

OHOH

OH

.H2O

Stage-III

dilute HCl Solution

(KRM)

+ HCl +Mol.wt: 36.5

H3PO3

Mol.wt:81.99

N

N

PPOH

OOOH

OHOH

OH

.H2O

Stage-III

N

N

PPOH

OOOH

OHOH

OH

.H2O

Minodronic acid hydrate

Stage-IV

Dilute HCl Solution

N

N

Stage-I

NaCl + CO2 + 2H2O

64. MINODRONIC ACID Manufacturing Process 2‐Aminopyridine is reacted with Chloroacetaldehyde in the presence of sodium bicarbonate in dichloromethane gives Imidazo [1, 2‐a] pyridine (stage‐I).Stage‐I is reacted with ethyl oxalyl chloride in toluene yields Imidazo[1,2‐a]pyridine‐3‐yl‐acetic acid ethyl ester, which is further hydrolyzed with potassium hydroxide to give Imidazo[1,2‐a]pyridine‐3‐yl (oxo) acetic acid which is reacted with hydrazine hydrate in the presence of potassium hydroxide in water to give stage‐II. Stage‐II is reacted with phosphorous acid and phosphorous trichloride. The resultant product is hydrolyzed with aqueous HCl solution to give 1‐Hydroxy‐2‐(Imidazo [1, 2‐a] pyridine‐3‐yl) ethane‐1, 1‐bis (phosphonic acid) monohydrate (Crude Minodronic acid). This is purified with dil HCl solution which gives pure Minodronic acid. Chemical Reaction

2-178

Material Balance

Total input Kgs.

Starting Material Product output MINODRONIC

ACID HYDRATE I

Quantity Kgs.

Output details

0.582 2‐Amino Pyridine 2.277 Aq. Effluent 0.983 Chloro Acetaldehyde 0.273 Carbon Dioxide 1.499 Sodium Bicarbonate

3.063 Total


Total input Kgs.

Starting Material

Product output MINODRONIC

ACID HYDRATE II A

Quantity Kgs.

Output details

0.512 Stage I 1.029 Aq. Effluent 1.479 Ethyl Oxalyl Chloride 0.015 Carbon Dioxide

1.991 Total


Total input Kgs.

Starting Material


ACID HYDRATE II B

Quantity Kgs.

Output details

0.947 Stage II A 0.180 Aq. Effluent 0.076 Water 0.019 Solvent Recovery

1.023 Total


Total input Kgs.

Starting Material


ACID HYDRATE II C

Quantity Kgs.

Output details

0.824 Stage II B 0.305 Nitrogen Gas 0.247 Potassium Hydroxide

1.071 Total


2-179

Total input Kgs.


ACID HYDRATE II

Quantity Kgs.

Output details

0.766 Stage II C ‐0.023 Evaporation loss 0.161 Hydrochloric acid

0.927 Total

0.950kgs ‐0.023 Total

Total input Kgs.


ACID HYDRATE III

Quantity Kgs.

Output details

0.950 Stage II 4.307 Aq. Effluent 1.098 Hypochloric Acid 0.009 Evaporation loss 2.763 PCI3 0.615 Water

5.427 Total


Total input Kgs.

Starting Material Product output MINODRONIC ACID HYDRATE

Quantity Kgs.

Output details

1.111 Stage III 0.078 Aq. Effluent 0.033 Evaporation loss

1.111 Total


2-180

O

O

O

O

CH3

CH3

COOEt

NH2.HCl

O

O

O

O

CH3

CH3 N

NH

OFormamidine acetate

Isopropyl alcohol

MF= C15H24ClNO6

MW= 349.79 MF= C14H18N2O5

MW= 294.30KSM-I

Stage-I

O

O

O

O

CH3

CH3 N

NH

OO

O

O

O

CH3

CH3 N

N

Cl

MF= C14H18N2O5

MW= 294.30

MF= C14H17ClN2O4

MW= 312.74

Stage-I Stage-II

Oxalyl chloride

Dichloromethane

O

O

OHOH

N

N

Cl

3-Ethnylaniline

Methanol,MDC

O

O

O

O

N

N

NH

Stage-II Stage-III

M.F:C 14H17ClN 2O5

M.wt:312.74

M.F:C 20H18ClN 3O4

.HCl

M.wt:429.82

65. ERLOTINIB Manufacturing Process Ethyl‐2‐amino‐4,5 (2‐methoxyethoxy) benzoic acid ester hydrochloride is treated with formamidine acetate in presence of isopropyl alcohol gets cyclized derivative. Which is further reacted with oxalyl chloride in presence of dichloromethane as a solvent yields chloro derivative (stage‐II). Which is condensed with 3‐Ethynylaniline in presence of methanol and methylene chloride yields Erlotinib hydrochloride. Chemical Reaction

2-181

Material Balance

Total input Kgs.

Starting Material

Product output ERLOTINIB

HYDROCHLORIDE‐I

Quantity Kgs.

Output details

2.272 KSM‐1 4.136 Aq. Effluent 3.840 Formamidinecetate 0.091 Evaporation loss

6.112 Total

1.886KGS 4.226 Total

Total input Kgs.

Starting Material

Product output ERLOTINIB

HYDROCHLORIDE‐II

Quantity Kgs.

Output details

1.886 Stage I 3.197 Aq. Effluent 3.244 Oxalyl chloride 0.462 Evaporation loss

5.130 Total


Total

input Kgs.


ERLOTINIB HYDROCHLORIDE

Quantity Kgs.

Output details

1.471 Stage II 1.529 Aq. Effluent 1.093 KSM II 0.034 Evaporation loss

2.563 Total


2-182

OH COOCH3

NO2H3CO

N

O

Cl.HCl

Potassium carbonate

Acetonitrile

COOCH3

NO2O

O

N

O

CH3KSM-IStage- I

COOCH 3

NO2O

O

N

O

CH3 Stage-I

COOCH 3

NH2O

O

N

O

CH3

Stage-IIA

NO

O

N

O

CH3

NH

O

Stage-II

10% Pd/C

Methanol

Formamidine acetate

NO

O

N

O

CH3

NH

O

Stage-II

NO

O

N

O

CH3

N

Cl

Stage-III

Phosphorous oxychloride

Dichloromethane

DMF

NO

O

N

O

CH3

N

Cl

Stage-III

NH2

F

Cl

Conc.HCl

Isopropyl alcohol

NO

O

N

O

CH3

N

NH

F

Cl

Stage-IV

66. GEFITINIB Manufacturing Process Methyl 5‐hydroxy‐4‐methoxy‐2‐nitrobenzoate is reacted with 4‐(3‐chlropropyl) Morpholine hydrochloride in Acetonitrile with suitable base to get stage‐I. This stage‐I is hydrogenated with hydrogen gas and palladium carbon then further treated with formamidine acetate to get the cyclized product. The cyclized product is chlorinated with phosphorous oxy chloride in presence of dichloromethane to get chloro pyrimidine derivative (stage‐III). Stage‐III is reacted with 3‐chloro‐4‐fluoroaniline in presence of isopropyl alcohol yields Gefitinib which is further purified with n‐propanol gets pure Gefitinib. Chemical Reaction

2-183

NO

O

N

O

CH3

N

NH

F

Cl

Stage-VNO

O

N

O

CH3

N

NH

F

Cl

Stage-IV

n-Propanol

Material Balance

Total input Kgs.


GEFITILNIB HYDROCHLORIDE I

Quantity Kgs.

Output details

1.299 KSM‐I 2.779 Aq. Effluent 1.260 KSM‐II 0.039 Evaporation loss 2.363 Potassium Carbonate 0.273 Carbon Dioxide

4.922 Total


Total input Kgs.


GEFITILNIB HYDROCHLORIDE II

Quantity Kgs.

Output details

1.831 Stage I 3.497 Aq. Effluent 1.831 Hydrogen gas 0.031 Evaporation loss 0.141 Pd/c 1.611 Formamidaceate

5.414 Total


Total input Kgs.


GEFITILNIB HYDROCHLORIDE III

Quantity Kgs.

Output details

1.886 Stage II 2.342 Aq. Effluent 1.999 POCI3 0.057 Evaporation loss


3.885 Total


Total input Kgs.


GEFITILNIB HYDROCHLORIDE IV

Quantity Kgs.

Output details

1.471 Stage III 1.103 Aq. Effluent 0.647 KSM‐III 0.015 Evaporation loss

2.118 Total


2-184

Total input Kgs.


GEFITILNIB HYDROCHLORIDE V

Quantity Kgs.

Output details

1.000 Stage IV Solvent recovery Solvent

1.000 Total

1.00kgs 0.000 Total

2-185

2.3 RAW MATERIAL STORAGE AND HANDLING

The raw materials shall be received in M.S. tank, HDPE/fibre drums, Carboys and cylinders as

well as through tankers. All the storage tanks of hazardous flammable substances shall be

located within premises in separate storage area i.e. Tank farm area & shall be stored in MS/SS

tank with all precautionary process instrumentation and safety appliances. Large area is

covered by well‐designed warehouse, which shall be containing store office, raw material store,

finished product store, etc. The personnel protective equipments like hand gloves, safety shoes,

goggles, helmet, clothing, etc. are provided to those handling hazardous chemicals as per

requirement. All the motors and electrical connections are flame proof. List of raw materials

are given in Table‐2.1.

TABLE – 2.1 LIST OF RAW MATERIALS EXISTING

SR. NO. NAME OF RAW MATERIAL QUANTITY (MT/MT PRODUCT)

Azithromycin Erythromycin Thiocyanate (IMP) 1.624 Hyflo Supercel 0.010 Hydroxylamine Hydrochloride 0.961 Para‐Toluene Sulphonyl Chloride 0.739 Acetone 2.209 Glacial Acetic Acid 0.118 Isopropyl Alcohol 1.842 Methanol 9.758 Sodium Bicarbonate 0.370 Sodium Hydroxide 0.661 Ammonium Thiocyanate 0.036 Sodium Chloride 0.938 Per Chloric Acid 0.435 Triethylamine 0.697 Methylene Chloride 4.193 Hydrogen Gas Cylinder Commercial 0.200 Nitrogen Gas Cylinder Grade‐1 0.414 Formaldehyde AR 0.230 Formic Acid 0.241 Platinum Metal 99.95% 0.083 Ammonia Solution 25% 6.068 Activated Carbon Qualigens SQ 0.053

1

Nitric Acid 70% 0.015 2 Clarithromycin

2-186

Erythromycin Oxime base 2.50

Methyl Iodide 0.521 Dimethyl Sulfoxide (D.M.S.O) 50.00 Hyflo Supercel 0.13 Potassium Hydroxide 0.28 Pyridine Hydrobromide 0.64 Sodium Bicarbonate 0.48 Sodium Hydroxide 2.84 Activated Carbon 0.063 Sodium Chloride 0.50 Methylene Chloride 24.84 Hexamethyl Disilazane 0.86 Sodium Bi Sulphite 7.50 2 Methoxy Propene 0.84 Formic Acid 0.50 THF 45.38 Dimethylamine Solution (40% in Water) 1.02 Absolute Ethyl Alcohol 65.39 Water 139.44 Roxithromycin BP/EP Methoxy Ethoxy Methyl Chloride 0.20 Sodium Methoxide 0.09 Oxime base 1.09 Acetone 5.44

3

Water 8.92 Fenofibrate 4‐Chloro 4‐Hydroxy Benzophenone 1.0 Chloroform 1.26 Ethyl Acetate 11.22 Hyflo Supercel 0.02 Sulphuric Acid (Colour Less) 2.4 Acetone 7.66 Isopropyl Alcohol 9.69 Sodium Bicarbonate 1.83 Sodium Hydroxide 1.28 Methylene dichloride 27.62 Activated Carbon Qualigens SQ 0.11

4

Water 24.91 Venlaflaxine HCL Ethyl Acetate 22.53 Raney Nickel Catalyst 0.05 Toluene 3.54 Isopropyl Alcohol 14.6 Methanol 2.57 Sodium Hydroxide 4.77 Sodium Sulphate Anhydrous 0.27 Sodium Chloride 0.34 Hydrochloric Acid‐Commercial 2.51 Formaldehyde AR 1.12 Formic Acid 1.94

5

IPA‐HCL Solution (10‐20 % HCLIN IPA) 1.09

2-187

Cyclohexanone Min 98% 0.66 4‐Methoxy Benzyl Cyanide 0.71 Water 30.14 Activated charcoal 0.01 Hyflo 0.04 Acetamide 0.29 Valsartan L‐Valine 1.44 Methanol 17.03 Thionyl chloride 6.90 Toluene 2.48 DCM 16.11 NaOH 2.28 NaCl 1.42 D.I. water 19.79 4‐Bromo Methyl 2‐cayno Biphenyl 2.17 Acetonitrile 9.45 Potassium carbonate 4.77 Oxalic acid 1.00 o‐Xylene 25.74 Valeroyl chloride 1.24 Conc. HCl 4.38 Tributyl Tin Chloride 5.55 Sodium Azide 13.29 Hexane 16.70 Tetra Butyl Ammonia Bromide 0.14 Calcium Hydroxide 0.42 Acetone 12.41 Ethyl acetate 21.41 Di Isopropyl Ether 14.36 Sodium bicarbonate 0.28

6

MDC 51.0 Irbesartan Sodium cyanide 1.34 Ammonium chloride 1.59 Ammonia solution 2.18 Cyclopentanon 2.05 Methanol 11.07 MDC 32.04 10% sodium Hupochlorite solu. 2.90 Water 9.85 32% Hydrochloric acid 25.85 Charcoal 0.14 Hyflo 0.15 Pyridine 8.0 Valeroyl chloride 1.69 DMF 4.58 4 Bromomethyl hydrate 2‐cynobiphenyl 1.63 Pthalamide 0.92 Potassium carbonate 1.24

7

80% Hydrazine Hydrate 0.44

2-188

NaOH 2.2 Toluene 34.37 NaCl 3 Methane sulfonic acid 0.69 Methyl T‐Butyl ether 5.95 O‐Xylene 15.22 Tributyltin chloride 2.39 Sodiumazide 0.72 95% ethanol 11.13 Telmisartan Acetone 35.67 Sodium Hydroxide 0.42 RM‐II 1.21 Water 21.78 Charcoal 0.032 Hyflo 0.07 Methanol 19.75 Hydroxide acid 0.72

8

MDC 10.05 Ropinorole 2‐Methyl‐3‐Nitrophenylethyl‐ N,N‐di‐n‐Propyl Ammonium oxalate

6.86

Sodium Methoxide Soln. 0.67 Diethyl Oxalate 3.33 H2O2 2.74 Ethyl Acetate 121.64 Sodium Hydroxide 1.92 THF 35.11 Acetonitrile 53.93 Hydrochloric Acid 7.68 Sodium Sulphate 1.68 Sodium Chloride 20.57 Process Water 589.63 Hyflo 4.10 PD/C Catalyst 0.48 Activated Charcoal 0.23 Sodium Dithionite 0.23 Ethanolic HCl 2.44 Ethanol 50.39 TEA 0.72 Methanol 164.95 DM Water 60.40 MDC 54.26 Sodium Carbonate 0.42

9

Cyclopentane 3.65 Lercanidipine hydrochloride 2,6‐dimethyl‐5‐methoxycarbonyl‐4‐(3‐nitrophenyl)‐1,4‐dihydropyridine‐3‐carboxylic acid

3.55

2,N‐dimethyl‐N‐(3,3‐diphenyl‐propyl)‐1‐amino‐2‐propanol 2.76 Di cyclohexylcarbodiimide 1.82

10

4‐Dimethyl aminopyridine 2.07

2-189

Activated charcoal 0.1 Hydrochloric acid 1.08 Toluene 5.36 Ethanol 2.88 Levetiracetam Sodium Sulphate 1.14 S9+) 2‐Amino‐Butryramide 1.14 Tetra Butyl Ammonium Bromide 0.057 4‐Chloro Butyryl Chloride 1.51 Potassium Hydroxide powder 2.87 Dichloromethane 18.88 Ethyl Acetate 13.24 Activated Charcoal 0.11 Hyflo 0.48

11

Glacial Acetic Acid 0.05 Topiramate Acetone 2.56 D‐Fructose 3.85 Sulphuric Acid 1.86 Dichloro methane 12.89 Cyclo hexane 7.34 Iso propyl alcohol 3.95 Sulfuryl Chloride 2.35 Pyridine 3.25 Citric Acid solution 0.46 Sodium Bicarbonate 1.06 Sodium Chloride 1.65 THF 5.24 Calcium Chloride 2.88 Ammonia gas 1.06 Acetic Acid 2.05 Methanol 12.08 DM water 15.23

12

Sodium Hydroxide 10.84 Pentosan Polysulfate Xylene 3.65 Chlorosulfonic Acid 3.25 Pyridine 8.12 Chlorine dioxide 1.06 Methanol 10.55 Sodium hydroxide 6.52 Glacial Acetic acid 2.54 30% Hydrogen Peroxide 7.26 Sulfuric acid 2.10

13

Water 10.66 Rivastigmine 3‐hydroxy acetophenone 2.54 Raney Nickel 0.01 Paraformaldehyde 2.78 D(+) camphor sulphonic acid 1.98

14

Sodium carbonate 2.55

2-190

Ammonia gas 1.70 Hydrogen gas 0.03 Sodium Sulphate 0.56 Methanol 6.75 Ethyl acetate 5.50 Ethyl alcohol 4.28 N‐ethyl N‐methyl carbamoyl chloride 2.04 L(+) Tartaric acid 1.05 Triethylamine 1.04 4‐dimethylamino pyridine 2.39 Toluene 7.28 Activated charcoal 0.02 O‐des Methyl Venlafaxine Venlafaxine Hydrochloride 1.50 Sodium Hydride 0.768 Ethane thiol 1.44 Sodium Hydroxide 0.44 Hydrochloric Acid 2.10 Activated Charcoal 0.15 Hyflo 0.50 Methanol 36.9 Water 3.45

15

Dimethyl Formamide 7.50 Leflunomide Ethyl acetic acetate 2.31 Triethyl ortho formate 4.56 Acetic anhydride 5.15 Process water 9.71 Hydroxylamine HCl 1.13 Caustic soda 0.65 Methanol 2.16 Sodium Chloride 1.11 HCl 0.09 MDC 10.70 Glacial Acetic Acid 1.47 IPA 0.36 Thionyl Chloride 1.49 Chloroform 5.92 TEA 0.66 Toluene 4.89 Acetone 0.97 Carbon 0.05

16

Hyflo 0.03 Modafinil PROCESS WATER 42.15 Thio Urea 0.36 Benzhydrol 0.73 HYDROBROMIC ACID 3.09 Caustic Soda 0.64 Chloroacetic Acid 0.43

17

HCl 1.82

2-191

Ethyl Acetate 9.85 Sod Sulphate 0.15 Hexane 1.87 Sod Bicarbonate 0.71 Methanol 3.21 Sulfuric Acid 0.27 Ammonia gas 1.36 DM Water 3.48 Acetic Acid 2.18 Hydrogen Peroxide 0.16 Lamotrigine Process water 107.50 Sulfuric Acid 20.10 Amino Guanidine bicarbonate 2.05 Acetonitrile 3.95 2.3 DBN 2.00 Sodium Hydroxide 1.30 N‐Propanol 73.40

18

Hyflo 0.20 Maprobamate 2‐Methyl‐2‐Propyl‐ 1,3‐Propanediol‐ Dichlorocarbamate 1.50 Ammonia solution 4.25 Activated Charcoal 0.01 Hyflo 0.06

19

Methanol 0.82 Pramipexole Dimethyl Formamide 3.26 4‐amino cycloheanol 2.56 Toluene 5.45 Phthalic anhydride 2.56 PPTS 0.005 Chloroform 4.33 Sod Bicarbonate 0.43 Sod Chloride 0.24 IPA 5.67 Sulfuric Acid 1.06 Process water 43.76 Methanol 7.98 Potassium Dichromate 3.74 MDC 12.79 Bromine 0.50 Aluminum Chloride 0.05 Thio Urea 2.56 Hydrazine Hydrate 1.03 Tri Ethyl amine 2.57 Acetonitrile 4.77 L(+) Tartaric Acid 3.88 Potassium Hydroxide 2.96 Hydrochloric Acid 1.98 Activated Charcoal 0.04

20

Ethanol 5.38

2-192

Ethanolic HCl 2.75 Alendronate Phosphorous Acid 1.09 Phosphorous Trichloride 1.82 Diphenyl Oxide 2.43 Methanol 1.77 Toluene 2.02 Sodium Hydroxide 1.14 Activated Charcoal 0.07 4‐Amino Butyric Acid 0.46 Celite 0.91

21

Water 5.55 Clonidine Hydrochloride 2,6‐Dichloroaniline 1.47 Acetic Anhydride 2.57 Formic Acid 0.76 DM Water 47.38 Thionyl Chloride 2.94 Dimethyl Formamide 0.02 Sulfuryl Chloride 0.75 Dichloromethane 16.17 Sodium Chloride 0.37 Ethylene Diamine 1.05 IPA HCL 1.17 Methanol 10.05 Activated Charcoal 0.13 Hyflo 0.5

22

Isopropanol 6.25 Famotidine ITU (KSM‐I) 1.36 Methanol 25.41 IF (KSM‐II) 1.36 Process Water 12.12 Sodium Hydroxide 0.83 Acetic acid 0.24 Charcoal 0.02 Hyflo 1.5

23

Aq. Ammonia 0.35 Fluoxetine Hydrochloride 3‐Chloro‐1‐ Phenyl Propanol (3‐CPPA) 1.1 Methanol 3.38 Aq. Methyl Amine solution 8.8 Sodium Iodide 0.04 Toluene 27.59 Sodium Hydroxide 0.31 DMSO 3.78 Sodium Hydride 0.22 4‐Chlorobenzotrifluoride 1.1 Hyflo 3 Sodium Bicarbonate 0.04

24

Sodium Chloride 0.13

2-193

Ethyl Acetate 3.86 Eno Carbon 0.06 Ethyl Acetate HCL 2.11 Olmesartan Medoxomil Trityl Olmesartan Medoxomil 1.93 Dichloromethane 19.3 Methanol 9.66 HCL 0.97 DM Water 35.71 Sodium Bicarbonate 0.97 Ethyl Acetate 15.44 Acetone 17.92 Activated Charcoal 0.03

25

Hyflo 1.5 Vildagliptin DMF 0.9 KSM‐II 0.12 KSM‐I 0.13 Potassium carbonate 0.12 Isopropyl Acetate 0.84 Dichloromethane 21.25 Process Water 11.13 Potassium Hydrogen sulfate 0.75 Potassium Carbonate 0.48 Sodium Chloride 0.63 Charcoal 0.05

26

Acetone 13.13 Metaprolol Tartrate‐ 1 4‐(2‐Methoxy ethyl) Phenol 0.65 Epichlorohydrine 0.7 Conc. Hydrochloric acid 0.704 Sodium Hydroxide 0.5 Hyflo 0.024 Toluene 6.6 Metaprolol Tartrate‐ 2 Acetone 9.402 MTT 0.913 Activated carbon 0.046 Tartaric acid 0.237

27

Hyflo 0.01 Metaprolol Succinate Acetone 0.027 Metoprolol Tartrate Stage‐II 0.892 Activated carbon 17.838 Succinic Acid 0.892

28

Hyflo 82.500 Quetiapine Fumarate‐I Toluene 20.30 DBT 0.66 Dimethyl aniline 0.53

29

POCl3 1.34

2-194

Sodium bicarbonate 0.05 Sodium Chloride 0.53 Activated carbon 0.03 Hyflo 0.03 (Hydroxyethoxy) ethyl) piperazine 1.12 Methanol 7.54 Fumaric acid 0.18 Quetiapine Fumarate‐II QUETIAPINE FUMARATE STAGE ‐ 1 1.13 METHANOL 15.32 SODIUM BICARBONATE 0.08 DILUTE METHANOL QUET ‐10.28 PURIFIED SILIXEOUS EARTH (HYFLO) 0.02 Deferasirox‐I Salicylic Acid 1.111 Thionyl chloride 1.433 O‐Xylene 4.444 N,N‐Dimethyl Formamide 0.022 SODIUM BICARBONATE 0.000 SODIUM HYDROXIDE 1.307 Methylene Chloride 1.961 Dilute O‐Xylene DEF‐1 0.0 Dilute Methanol DEF‐1 0.0 Salicylamide 0.99 Methanol 4.44 Deferasirox Stage‐ II Deferasirox Stage‐ I 0.822 4‐Hydrazino benzoic acid 0.575 Absolute Ethyl Alcohol 6.454 Potassium hydrogen Sulphate 0.123 Methanol 1.947 SODIUM BICARBONATE 0.064 Dilute ethanol DEF‐1 0.000 Dilute N,N‐Dimethyl Formanic ‐9.628 N,N‐Dimethyl Formamide 11.344 Hydrogen peroxide 1.980 Deferasirox Stage‐ III Deferasirox Stage‐ II 1.091 Methanol 19.273 Ethyl Acetate 12.000 Hyflo 0.073 Dimethyl Formamide 21.091 SODIUM BICARBONATE 0.00 Mix Solven‐DEF3 0.00

30

Activated Carbon 0.073 LACOSAMIDE‐I ETHYL ACETATE 5.68 TOLUENE 7.28 ACETONE 3.57 SODIUM HYDROXIDE 0.75

31

POTASSIUM HYDROGEN SULPHATE 2.91

2-195

D‐SERINE 0.73 Di tert‐butyl di Carbonate 2.42 DILUTE ETHYL ACETATE Lacosamide Stage‐I ‐7.34 DILUTE TOLUENE Lacosamide Stage‐I ‐7.11 LACOSAMIDE‐II ETHYL ACETATE 0.431 ACETONE 2.951 METHANOL 4.174 SODIUM BICARBONATE 0.078 CYCLOHEXANE 6.160 METHYLENE CHLORIDE 11.917 POTASSIUM HYDROGEN SULPHATE 0.288 Methyl chloroformate 0.490 N‐methyl Morpholine 0.519 Benzyl amine 0.499 Lacosamide Stage‐I 0.961 DILUTE MDC Lacosamide Stage‐II ‐6.973 DILUTE EAC+CYLO‐H Lacosamide Stage‐II ‐7.289 LACOSAMIDE‐III TOLUENE 6.76 METHANOL 0.98 SODIUM BICARBONATE 0.30 SODIUM HYDROXIDE 0.42 CYCLOHEXANE 2.38 Dimethyl Sulphate 1.16 Tetra Butyl Ammonium Bromide 0.21 Lacosamide Stage‐II 1.13 Dilute Toluene 0.00 Dilute Cyclohexane 1.75 Recovered toluene LAC‐3 ‐4.30 Recovered Cyclohexane LAC‐3 1.13 LACOSAMIDE‐IV PURIFIED SILIXEOUS EARTH (HYFLO) 0.06 N‐HEPTANE 99% 16.59 HYDROCHLORIC ACID PURE COLOURLESS (DRUM) 3.08 ACETONE 8.45 ISOPROPYL ALCOHOL 3.55 METHANOL 8.36 SODIUM BICARBONATE 0.38 SODIUM HYDROXIDE 0.90 SODIUM CHLORIDE 0.68 METHYLENE CHLORIDE 50.08 ACTIVATED CARBON QUALIGENS SQ 0.08 ACETIC ANHYDRIDE 0.66 Lacosamide Stage‐III 1.51 DILUTE MDC Lacosamide Stage‐IV ‐23.58 DILUTE IPA Lacosamide Stage‐IV ‐1.51

DILUTE IPA+N‐HIPTANE Lacosamide Stage‐IV ‐15.57 HYDROCHLOROTHIAZIDE ‐ 1ST STAGE 4‐Amino‐6‐Chloro‐1,3‐benzenedisulfonamide (CBD) 1.059

32

Para formaldehyde 0.122

2-196

Methanol HYDROCHLOROTHIAZIDE – 2nd STAGE 1.111 Activated Charcoal (Norit Make) 0.026 Hyflo 0.017 Ammonia Solution 2.778 Hydrochloric Acid Pure (Colorless) 3.222 Sodium Hydroxide 0.437 SODIUM BICARBONATE 0.214 Linezolide‐I Sodium Azide 0.304 METHANOL 0.00 Dimethyl Formamide 3.750 SODIUM BICARBONATE 0.00 (R)‐[N‐3‐(3‐Fluoro‐4‐MORF)] 1.250 HCL 0.00 Sodium Nitrate 0.00 Linezolide‐II Ethyl Acetate 56.441 Purified siliceous earth 0.68 Toluene 9.831 Acetone 20.339 Methanol 6.780 10% Palladium Charcoal 0.092 Triethylamine 0.978 Acetic Anhydride 0.505 Activated Carbon 0.031 Hydrogen Gas 0.610 Nitrogen Gas 1.661 Silica Gel 0.847 Linezolide stage‐I 1.11525 10% Palladium Charcoal ‐0.010 10% Palladium Charcoal 0.096 10% Palladium Charcoal ‐0.087 Dilute Acetone line ‐1.098 Dilute Methanol line ‐1.728 Dilute Toluene line ‐2.110 Sodium Bicarbonate 0.00 Recovered Acetone line ‐6.076

33

Recovered Ethyl acetate ‐46.026

2-197

PROPOSED SR. NO. NAME OF RAW MATERIAL QUANTITY

(KG/KG PRODUCT)

Memantine hydrochloride‐I 1‐Bromo‐3, 5‐ Dimethyladamantane 2.13 Acetonitrile 2.13 Sulphuric Acid 4.25 Process water 47.81 Toluene 16.26 Sodium Hydrosulfite 0.02 Sodium bicaronate 0.11 Memantine hydrochloride‐II Polyethylene Glycol‐400 5.73 Satge‐1 1.43 Sodium Hydroxide 1.43 Toluene 42.34 Process water 207.61 Activated Charcoal 0.07 Hyflo 2.15 Hydrochloric Acid 0.80 Memantine hydrochloride‐III Isopropyl Alcohol 30.3 Stage‐2 1.25 Activated Charcoal 0.06

34

Hyflo 0.06 Pregabalin ®‐(‐)‐3(Cabamoyl methyl)‐5‐Methylhexanoic Acid 1.333 Bromine 1.195 Hydrochloride 0.307

35

Sodium Hydroxide 1.853 Ivabradine 1,3‐Dihydro‐7,8‐dimethoxy‐2H‐3,3 Benzazapin 0.947 sodium Iodide 0.102 KSM II 0.321 Hydrogen Gas 0.475 Potassium tert Butoxide 0.533 Potassium Carbonate 0.549 Hydrochloric Acid 0.604 Stage II 0.784 1‐Bromo‐3‐Chloro propane 1.020 Stage I 1.188

36

Stage III 1.333 Azilsartan 4‐hydroxymethyyl‐5‐methyl‐1,3‐dioxol‐2‐one(KRM) 0.491 Acetic Acid 0.173 ECF 0.558 hydrochloric acid 1.051 Hydroxyl Amine‐HCI 4.233 KSM 2.505 Potassium Ethyl Hexonate 0.398

37

Potassium Carbonate 0.942

2-198

p‐TSCI 0.636 Sodium Carbonate 6.462 Sodium Hydroxide 0.415 Stage I 2.079 Stage II 1.622 Stage III 1.103 Stage IV 1.136 Etoricoxib Acetic Acid 2.283 Acetone 2.781 Activated Carbon 0.022 Ammonia Solution 10.871 D M Water 45.343 Etoricoxib‐I 1.107 Hexane 0.260 Hyflow 0.230 Isopropyl Alcohol 25.054 Ketosulfone 1.574 Methanol 9.706 Tri Hydrofuron 22.273

38

Trifluro Acetic Acid 0.465 Derifenacin KSM I 2.307 Sodium Hydroxide 0.551 Stage IA 1.753 Sulphuric Acid 0.456 Tartaric Acid 0.771 Stage I 1.429 KSM II 0.757 Potassium Carbonate 2.286

39

Hydrogen Bromide 0.300 Celecoxib 1‐(4‐Methylphenyl)‐4,4,4 Trifluorobutane 1,3‐dione 0.754 4‐Methylacetophenon 0.443 D M water 12.282 Ethyl Alcohol 0.237 Ethyl Trifluro Acetate 0.562 Isopropyl Alcohol 8.447 Methanol 0.019 Sodium Methoxide 0.356 Sulphuric Acid 0.515 Toluene 2.113 Trifluoro Acetic Acid 0.396

40

4‐Sulphonamino Phenyl Hydrazine 0.769 Rabeprazole Sodium 2‐Mercepto Benzimidazole 0.647 RAB / Chloro 1.097 RAB / Hydroxy 1.097 RAB / I 1.316 RAB / II 1.053

41

Sodium Hydroxide 0.494

2-199

Sodium Hydroxide 0.811 Sodium Hypo chloride 4.054 Thionyl Chloride 0.636 Clopidogrel Bisulfate 2‐Thienylethyl Para‐ toluene sulphonate 1.590 2‐Thiophene ethanol 3.052 Aqu.Formadehyde 1.346 Dipotassium hydrogen Sulphate 1.510 DL‐2‐chlorophenyl glycine 5.087 DM Water 27.508 Free Base 1.282 Hydrochloric Acid 0.652 Methanol 12.310 N‐(3‐chloro‐4‐methoxyphenyl)Acetamide 1.648 p‐toluene Sulphonyl chloride 3.967 Sodium Bicarbonate 5.188 Stage I 6.104 Stage II 3.052 Stage IV 0.890 Sulphuric Acid 0.368 Tartaric Acid 3.662 Thionyl Chloride 6.816

42

Triethyl Amine 4.975 Felodipine 2,3 Dichloro Benzaldehyde 0.667 2,3 Dichlorobenzylidine Methylacetoacetate 1.000 3‐Amino Crotonic acid Ethyl ester 0.630

43

Methyl Aceto Acetate 0.465 Prasugrel Hydrochloride 2‐Acetoxy‐5‐(Cyclopropylcarbonyl‐2‐Fluorobenzyl)‐4,5,6,7‐Tetrahydrothieno[3,2‐c] Pyridine Maleate 1.481 2‐Oxe‐(Cyclopropylcabonyl‐2‐Fluorobenzyl)‐2,4,5,6,7,7a‐HexahydroThieno[3,2‐C] Pyridine 1.299 5‐Triphenylmethyl‐2‐Oxo‐2,4,5,6,7,7a‐Hexahydro Thieno[3,2‐c] Pyridine 1.804 Acetic Anhydride 1.533 Acetone 31.356 Hydrochloric Acid 1.408 KSM Stage II 1.516 Maleic Acid 0.402 Sodium Bicarbonate 2.891 Stage I 0.866 Stage II 1.234

44

Stage III 1.111 Mexiletine Hydrochloride 2‐Phenyl ethanol 0.781 3,4‐Methylene Dioxymetham Phetamine (Stage I) 1.366 Epichlorohydrine 0.648 Hydrogen chloride 0.218 Hydrogen Gas 0.027 Hydroxylamine Hydrochloride 0.652

45

Mexiletine 0.990

2-200

p‐Methoxy‐Benzyl acetone (stage I) 1.035 Potassium carbonate 1.058 Potassium Iodide 0.064 Sodium carbonate 1.407 Warfarin 2‐Hydroxy Acetophenone 0.769 4‐Hydroxy Coumarine 0.769 Benzal Acetone 0.693 Diethyl Carbonate 1.000 Sodium Methoxide 0.762

46

Triethylamine 0.046 Bazedoxifene (Benzyloxy)Aniline Hydrochloride(Amine, 2.147 (Benzyloxy)phenyl]‐2‐bromopropan‐1‐one (Bromo 1.167 (Chloro Methyl)Phenoxy]ethyl}azepane 1.082 [4‐(benxyloxy)phenyl]‐3‐methyl‐indole(Indole) 0.992 4‐Nitrophenol(P‐Nitro phenol) 0.819 5‐(Benzyloxy)‐2‐[4‐(phenyl)phenyl]‐3‐methyl 1.538 Acetic Acid 0.138 Activated Charcoal 0.123 Anhydrous Ferric Chloride 0.012 Anhydrous Potassium Carbonate 1.138 Benzyl chloride 0.729 Benzyl‐4‐nitrophenylether(Nitro compound) 1.228 Hydrazine Hydrate 0.860 Hydrochloric Acid 0.197 Hydrogen 0.015 Potassium Iodide 0.098 Sodium‐tert‐butoxide 0.909

47

Triethylamine 0.924 Bosentan 4,6‐Dichloro‐5‐(2‐Methoxyphenoxy)‐2,2‐Bipysimidine 0.726 4‐Tert‐Butylbenzene Sulfonamide 0.443 BOS / I (Crude) 1.053 BOS / I (Pure) 1.000 BOS / II 1.053 BOS / IV 1.053 Ethylene Glycol 12.339 Hydrochloric Acid 0.179 Potassium Carbonate 2.203

48

Water 8.421 Febuxostate KSM 1.547 Isobutyl Bromide 1.162 Potassium Carbonate 1.834 (Ethyl 2‐(3‐Formyl‐4‐Isobutoxyphenyl)‐4‐Methylthiazole‐5‐Carboxylate) 1.470 Ammonium Hydroxide. HCl 0.323 Sodium Carbonate 0.314 (Ethyl 2‐(3‐Cyano‐4‐Isobutoxyphenyl)‐4‐Methyl‐5‐thiazoleCarboxylate) 1.352 Sodium Hydroxide 0.297

49

Hydrochloric Acid 0.289

2-201

Stage III (Tech) 1.149 Acetone 0.750 Dronedarone 1‐Chloro‐3‐Dibutyl Amino propane 0.714 2‐N‐Butyl‐3‐(4‐(3‐Dibutylaminopropo)Benzoyl)‐5‐Nitrobenzofuran 1.610 2‐N‐Butyl‐3‐(4‐(3‐Dibutylaminopropoxy‐benzoyl)‐5‐Amonibenzofuran Dioxalate 1.626 2‐N‐Butyl‐3‐(4‐(3‐Dibutylaminopropoxy‐benzoyl)‐5‐Amonibenzofuran Pure 1.182 2‐N‐Butyl‐3‐(4‐(3‐Dibutylaminopropoxy‐benzoyl)‐5‐Amonibenzofuranamidobezofuran 1.371 2‐N‐Butyl‐3‐(4‐Hydroxybenzoyl)‐5‐Nitrobenzofuran 1.073 Aq. Ammonia Solution 1.138 Dronedarone HCl crude 1.220 Ethyl Acetate HCl 1.283 Hydrogen Gas 0.016 Methane Sulfonyl chloride 0.253 Oxalic Acid Dihydrate 1.294 Potassium carbonate 0.480

50

Pyridine 0.141 Dabigatran 1‐Methyl‐2‐Pyrolidone 2.004 Acetic Acid 2.043 Ammonia 0.116 DIPEA 1.278 Hydrochloride 0.245 KSM I 1.945 KSM II 1.101 Methane Sulfonic Acid 0.153 N‐Hexyl Chloroformate 0.618 Pivaloyl Chloride 0.920 Stage I 1.634 Stage II 1.307 Stage III 1.111

51

Triethyl Amine 0.986 Rivaroxaban (4‐4‐Aminophenyl)‐morpholin‐3‐one 1.411 4‐Dimethylaminopyridine(DMAP) 0.007 5‐Chlorothiophene‐2‐cacoxylic acid 1.220 Aq. Methyl Amine 1.627 CDI 4.034 DMF SKSM NDMF‐ST‐II 1.829 DMF ST 1.968 Glycidyl Phthalimide 1.637 Hydrochloric Acid 0.677 Oxalyl Chloride 1.495 Sodium Acetate 1.476 Stage I 2.187

52

Stage II 1.143 Asenapine Ammonium Hydroxide 74.716

53

Cesium Carbonate 8.159

2-202

CuCI2.(H2O)2 9.450 Cuprous chloride 2.375 Fumic Acid 1.308 Hydro Chloric Acid 11.304 Hydrogen Gas 0.034 Maleic Acid 0.456 N,N‐Dimethylglycine hydrochloride 1.747 NH4OH 18.571 Nitro Oxepine 1.701 Sodium Nitrite 0.474 Sodium Sulphite 6.899 Trans‐N‐methyl‐4‐(2‐bromophenyl)‐3‐(2‐hydro‐5‐nitrophenyl) 4.725 Silosodine 3‐Chloropropano 1.000 Benzyl Bromide 1.664 Bromide 0.590 Copper Cyanide 0.240 DMF 383.9 Hydrogen Bromide 1.000 Indoline 1.000 POCI3 321.3 Sodium Bromide 0.863 Sodium Hydroxide 2.650 Sodium meta Bisulphate 0.130 Stage I 1.860 Stage II 270.0 Stage III 1.000 Stage IV 1.000 TBAB 0.000

54

Water 1354.0 Zolmitriptan (S)‐4‐(4‐Amino Benzyl)‐1,3‐Oxazolidin 2‐One 1.754 (S)‐4‐(4‐Hydrazinyl Benzyl)‐1,3‐Oxazolidin 2‐One 1.891 4‐Dimethylamino Butanal Diethyl Acetate 1.728 Hydrochloric Acid 1.796 Sodium Nitrite 0.661

55

Sodium Sulphite 0.460 Iloperidone 4‐Methoxy‐3‐hydroxy Acetophenone 0.549 1‐Bromo‐3‐Chloropropane 1.044 6‐Fluoro‐3‐(4‐piperidinyl)‐1,2‐benzisoxazole hydrochloride 0.756 Iloperidone 1.000 Methanol 0.500 Potassium Carbonate 0.457 Potassium Carbonate 0.508 Sodium Bromide 0.303

56

Stage I 0.714 Agomelatine 2‐(7‐methoxy ‐1‐napthyl)ethylamine hydrochloride 1.000 2‐(7‐methoxy‐1‐napthyl) Acetonitrile/ Agomelatine 1.000

57

Acetic Anhydrous 0.510

2-203

Hydrogen Gas 0.020 Isopropyl Alcohol HCL 0.740 Sodium Acetate Anhydrous 0.420 Ticagrelor DIPEA 2.085 Hydrochloric Acid 0.953 KSM‐I 1.985 KSM‐II 1.489 Potassium Carbonate 0.381 Sodium Hydroxide 0.376 Sodium Nitrite 0.506 Stage I 1.886

58

Stage II 1.471 Metaxalon 3,5‐Dimethylphenol 1.840 Aq. Potassium Hydroxide 1.014 Epichlorohydrine 1.393 Ethylcarbamate 0.805 Stage‐I 1.610

59

Triethylamine 0.177 Vilazodone Hydrochloride 4‐Chloro‐N,N,2‐Tri‐Methyl‐7‐Quinolinamine 0.668 5‐Nitrosalicyladehyd 0.726 Ammonia 0.110 Bis(2‐Chloroethyl)Amine HCl 0.950 Diethyl Bromo Malonate 0.835 Dimethyl Bromo Malonate 1.249 Hydrogen Chloride 0.091 Hydrogen Gas 0.025 Potassium Carbonate Powder 1.811 Stage I 1.044 Stage IIA 1.566 TBAB 0.115 Trimethyl Amine 3.028

60

Vilazodone (Stage II) 1.143 Teriflunomide 2‐Cyano‐N‐[4‐(Trifluoro Methyl)phenyl]Acetamide 1.136 4‐(Trifluoro Methyl)Aniline 1.291 Cyano Acetic Acid 0.800 Hydrochloric Acid 1.136 Isopropenyl hydroxide 0.897 PCI5 1.962

61

Sodium Hydroxide 0.735 Nisoldipine 2‐Nitrobenzaldehyde 0.625 2‐Nitrobenzylidine Aceto acetic acid Isobutyl Ester 1.204 Isobutyl Acetoacetate 0.620

62

Methyl‐3‐Amino Crotonate 0.714 Fesoterodine Fumarate Benzyl amine (Free base) 2.836

63

Benzyl amine DPTT 5.454

2-204

Benzylated Free Base(Inst) 2.585 Cerric Ammonium nitrate 12.544 Dihydroxy Compound 1.017 Fesoterodine Base(Inst) 1.230 Fumaric Acid 1.477 Hydrogen gas 0.013 Isobutyryl chloride 0.340 NaBH4 0.774 Sodium Carbonate 5.726 Stage I 3.272 Stage I A 2.945 Stage I B 2.945 Triethylamine 0.301 Water 0.109 Minodronic acid 2‐Amino Pyridine 0.582 Chloro Acetaldehyde 0.983 Ethyl Oxalyl Chloride 1.479 Hydrochloric acid 0.161 Hypochloric Acid 1.098 PCI3 2.763 Potassium Hydroxide 0.247 Sodium Bicarbonate 1.499 Stage I 0.512 Stage II 0.950 Stage II A 0.947 Stage II B 0.824 Stage II C 0.766 Stage III 1.111

64

Water 0.691 Erlotinib Formamidinecetate 3.840 KSM II 1.093 KSM‐1 2.272 Oxalyl chloride 3.244 Stage I 1.886

65

Stage II 1.471 Gefitinib Ethyl Alcohol 0.600 Formamidaceate 1.611 Hydrogen gas 1.831 KSM‐I 1.299 KSM‐II 1.260 KSM‐III 0.647 Pd/c 0.141 POCI3 1.999 Potassium Carbonate 2.363 Stage I 1.831 Stage II 1.886 Stage III 1.471

66

Stage IV 1.000

2-205

2.4 INFRASTRUCTURE FACILITIES

2.4.1 LAND

Total 68,530.26 m2 land area is available at site; out of this 24,000 m2 (i.e. approx 35 % of total

area) is developed as greenbelt and other forms of greenery.

2.4.2 TRANSPORTATION FACILITIES

Transportation of all the raw material and products shall be primarily by road only.

2.4.3 WATER AND WASTEWATER

Total water requirement will be 397.5 m3/day which shall be met through own bore well (160

m3/day) & recycled treated wastewater (237.5 m3/day). Wastewater generation will be 195

m3/day (Industrial) & 50 m3/day (domestic) = 245 m3/day (total) and shall be treated in ETP.

Out of 245 m3/day wastewater generation, 237.5 m3/day wastewater is reused as it is RO

permeate water, 5 m3/day is recovered Solvent and 2.5 m3/day is MEE Concentrate. Details of

water consumption and wastewater generation are given in Table 2.2.

2-206

TABLE ‐ 2.2

WATER CONSUMPTION & WASTEWATER GENERATION (EXISTING) Sr. No.

Usages Water Consumption (m3/day)

Wastewater Generation (m3/day)

1 Domestic 55 50 2 Industrial Process & Washing 90 85 Cooling 5 (Fresh) + 35* (Recycled) 15 Boiler & Other 10 5 Total (Industrial) 105 (Fresh) + 35 (Recycled) 105 Grand Total 195 =

160 (Fresh) + 35 (Recycled) 155

* MEE Condensate # RO Permeate i.e. 63 m3/day is also reused/recycled back in Plant WATER CONSUMPTION & WASTEWATER GENERATION (TOTAL AFTER PROPOSED EXPANSION)

Sr. No.

Usages Water Consumption (m3/day)

Wastewater Generation (m3/day)

1 Domestic 55 50 2 Gardening 27.5 ‐ 3 Industrial Process 50 45 Washing 115 115 Boiler 50 10 Cooling 100 25 Total (Industrial) 315 195 Grand Total 397.5 =

160 (Fresh) + 237.5 (Recycled) 245*

Note: * Out of 245 KL/Day wastewater generation, 237.5 KL/Day wastewater will be reused as it is RO permeate water, 5 KL/Day is recovered Solvent and 2.5 KL/day is MEE Concentrate.

2-207

WATER BALANCE DIAGRAM (EXISTING)

2-208

150 KL

Washing

Boiler

Cooling Tower

115 KL

50 KL

100 KL

Losses 75 KL

Losses 40 KL

115 KL

10 KL

45 KL

37.5 KL Reject

ETP (NEW)

150 KL RO + 2

Stripper 40 KL

Recover Solvent 5 KL

Plantation: 27.5 KL

Raw Water Quantity: 160 KL

Process: 50 KL

05 KL LOSS

MEE 119.5 KL

ETP (OLD) 167 KL

167 KL RO 1

125 KL Permeate

55 KL Domestic

50 KL

117 KL Distilled

25 KL

112.5 KL Permeate

42 KL Reject

2.5 Concentrate

Water Balance Diagram (Total After Propose Expansion) API-1

2-209

2.4.3.1 TREATMENT PROCESS (EXISTING)

Process Description

All the Raw effluent coming in low COD is collected in the 4 separate storage tank. After by gravity going in to the Equalization tank. Before it collecting in to Equalization all effluent is passing through the settling, Oil & Grease tank, where all oily and suspended floating materials is removed. The two‐equalization tank are operated alternatively i.e.normaly while the one is under receiving, the other is put for further treatment of effluent. The treated effluent from this tank is pumped to a Flocculator tank.

In the flocculator polyelectrolyte, PAC or Alum dosing is carried out in effluent. This effluent goes to the primary clarifier ,where the sludge formation done in flocculation & here in clarifier sedimentation process are happen, so the settled sludge is diverted to sludge drying beds / Filter press and Clear Liquid goes to the collection tank and then it is pumped to the bio tower as a part of COD reduction procedure.

Treated water of the bio tower is pumped to the Aeration tank‐1. In Aeration tank‐1 diffused aeration system is installed, where stabilized biomass is already there. The diffused aeration system gives effective biological degradation and overflowed from here go to secondary clarifier‐1 by gravity. The activated bio‐sludge is re‐circulated back to aeration tank‐1 and excess sludge is drained to sludge drying beds or decanter. We have the Two‐ Parallel Aeration system. The Overflow of Aeration atnk‐1 is goes to aeration tank ‐2. Link Aeration Tank‐ 1 submerged diffused aeration system is installed in Aeration Tank‐2 also. Treated effluent from Aeration Tank‐ 2 goes to secondary clarifier‐2. The activated bio‐sludge is re‐circulation back to aeration tank‐2 and excess sludge is drained to sludge drying beds. Overflow of the clear effluent from secondary clarifiers goes to hold up sump. Treated effluent from Hold up sump is pumped to the PSF & ACF for the tertiary treatment polishing unit.

Out let of ACF is pumped to R.O. feed tank for further treatment in Reverse Osmosis System (RO System). The reject water of R.O. system goes to the Multi Effect Evaporator Plant. While permeate water is collected in storage tank and pumped in the plant for reused in cooling tower and scrubber. The high COD effluent as per the effluent segregation scheme collate in neutralization tank. After neutralization high COD effluent treated through Solvent stripper and after removal of solvent effluent is treated in Multi Effect Evaporator plant and concentrated mass of MEE is centrifuged. Filter of centrifuge is recalculated back in MEE and solid is kept in solid waste storage area, which is incinerated and Ash is send to NECL, Nandesari secured land filled site as a part of Hazardous waste authorization. Distilled of MEE is reused in plant for mark of Quencher & Scrubber of Incinerator and cooling tower.

2-210

DETAILS OF ETP UNITS (Existing)

SR.NO DETAILS OF COMPONENTS NUMBERS DIMENTION (MTS)

1 Equalization Tank 02 3.86 X3.86X3.2 (95.25 m3)

2 PH adjustment Tank 01 2.2 X 2.2 X 2.2 (10.65 m3) 3 Neutralization Tank 01 1.6 X 1.6 X 1.7 (4.35 m3)

4 Primary Clarifier 01 3m X 2.5m (17.66 m3)

5 Aeration Tank ‐ II 01 5.4 X 5.4 X 3.0 (87.48 m3)

6 Secondary Clarifier ‐ II 01 3m X 2.5m (17.66 m3) 7 Storage Tank 01 50 m3

8 Oil & grease trap 01 2.1 X6.0 X 1.3 (16.38 m3) 9 Aeration Tank ‐ I 01 13 X 21 X 4.8 (1300 m3)

10 Secondary Clarifier ‐ I 01 3.0 X 3.0 (22 m3)

11 Bio Tower 01 12.0 X 5.8

12 High COD Collection Tank 01 1.8 X 2.35 X 1.2 (5 m3) EFFLUENT TREATMENT PLANT PROCESS (PROPOSED) Process Description:‐

All low COD Streams is collected in 4 separate storage tanks which by gravity send to equalization tank through oil skimmer, where all oily and suspended floating material is removed. The equalization tank is having two parts which are operated alternatively i.e. normally while the one is under receiving; the other is put for further treatment of effluent. Low COD streams, utility waste water and other process shall be collected in this tank for homogenization, equalization and storage purpose to prevent any shock loading. Equalization tank is provided with a Coarse Bubble Diffused air system for equalize and mixing purpose. The treated effluent from this tank is pumped to a Flash mixer/Neutralization Tank for PH adjustment and flocculation and effluent goes to the primary clarifier ,where sludge is settled which is diverted to sludge drying beds or Decanter and Clear Liquid from Primary Clarifire‐1 goes to Anoxic Tank .

In the Anoxic tanks, wastewater is passes through Nitrification and De nitrification processes. After this processing, the effluent is send to the biological system. In Aeration tank‐1 diffused aeration system is installed, where stabilized biomass is already there. The diffused aeration system gives effective biological degradation and overflowed from here go to secondary clarifier‐1 by gravity. The activated bio‐sludge is re‐circulated back to aeration tank‐1 and excess sludge is drained to sludge drying beds or decanter. We have two Extended Aeration system in series. The Overflow of Aeration atnk‐1 is goes to aeration tank ‐2. Each Aeration is followed by dedicated Clarifier to remove dead bacterial mass.

Submerged diffused aeration system is provided in both tanks. The activated bio‐sludge is re‐circulated back to both aeration tanks and excess sludge is drained to sludge drying beds.

2-211

Overflow of the clear effluent from secondary clarifiers‐2 goes to hold up sump. Treated effluent from Hold up sump is pumped to the PSF & ACF for the tertiary treatment polishing unit.

In the pressure Sand Filter, Sand filtration is provided as a form of tertiary treatment for removal of residual suspended solids. Clear Liquid from PSF goes to Activated Carbon Filter. In Activated Carbon filter will be provided as a form of tertiary treatment for removal of colors, odor and residual organics.

Out let of ACF is pumped to R.O. feed tank for further treatment in Reverse Osmosis System (New 150 KLD Two stage RO System). The reject water of R.O. system goes to the Multi Effect Evaporator Plant. While permeate water is collected in storage tank and pumped in the plant for reuse in cooling tower and Boiler. DETAILS OF ETP UNITS: PROPOSED (150 KL/DAY) Sr. No Details of Components Numbers Capacity 1 Screen. 1 RCC 0.1M3 2 Oil & Grease Trap 1 RCC 18.75M3 3 Equalization Tank A‐B 2 RCC 75 M3 3 Primary Settling tank 1 RCC 24 M3 4 Anoxic Tank 1 RCC 65 M3 5 Aeration Tank – I 1 RCC 562M3 6 Secondary Clarifier Tank‐ I 1 RCC 24 M3 7 Aeration Tank – II 1 RCC 282 M3 8 Secondary Clarifier Tank– II 1 RCC 24 M3 9 Filter Feed Sump 1 RCC 9.5 M3 10 Sludge Collection Sump 1 RCC 5.0 M3 11 Treated Effluent Collection Tank 1 RCC 680 M3 Mechanical Instrumentation & Electrical Items

Sr. No

Description Specification Unit Quantity

1 Bar Screen For washing stream & Domestic Waste Water

Stainless Steel 5 mm &10 mm Size 300 mm wide X 300mm high.

No 2

2 Deoiler Pipe for washing 15 mm dia with 40 mm slot on M.S Pipe

No 1

3 Air Blower for Equalization Tank 135 m3/hrs No 1+1 4 Coarse Bubble Diffusers for

Equalization Tank FAD 8‐10 m3/hrs Lot 1

5 Effluent Transfer Pumps 8 m3/hrs No 1+1 6 Flash Mixing Tanks HDPE 500 Lit No 2 7 Flash Mixer Agitator 0.5 HP M.S FRP No 2 8 Chemical Dozing Tank With 500 Lit HDPE/FRP No 4

2-212

Agitator 9 Chemical Dozing Pumps 0‐50 LPH No 2+2 10 Chemical Dozing Pumps 0‐10 LPH No 2+2 11 Primary Settling Tank. Clarifier mechanism Lot 1 12 Primary Sludge Pump 3 m3/hrs No 1+1 13 Air Blowers for Aeration Tank‐1 600 m3/hrs No 1+1 14 Air Blowers for Aeration Tank‐2 235 m3/hrs No 1+1 15 Fine Bubble Air Diffusers For

Aeration Tank 1&2 FAD 5‐8 m3/hrs Lot 1

16 Secondary settling Tank.‐1 & 2. Clarifier mechanism Lot 2 17 Secondary Sludge Pumps 3 m3/hrs No 2+2 18 Filter Feed Pumps 8 m3/hrs No 1+1 19 Pressure Sand Filter 8 m3/hrs No 1 20 Activated Carbon Filter 8 m3/hrs No 1 21 Decanter Feed Pump 3 m3/hrs No 1+1 A.T.F.D. PROCESS (850 LIT/HRS) Process Description:‐ Agitated Thin Film Dryer Vertical In a vertical dryer, the rotor blades is hinged. The feed enters the shell tangentially and gets spread along the inside surface of the shell into a thin film. The hinged rotor blades keep the film under intense agitation preventing any scale formation. The feed progressively passes through different phases like liquid, slurry, paste, wet powder and finally powder of desired dryness. The vapors flow counter current to the film. The powder gets collected in a powder receiver at the bottom.

Due to its inherent design features, it is ideal for thermal treatment of solutions and heat sensitive products, where reduced operating temperatures and vacuum operating pressures are desirable. The typical Agitated Thin Film Evaporator consists of a tubular heat transfer area with an external heating jacket and a fast‐revolving, inner rotor with flexible or rigid wiper elements. The driving speed is adapted to the product being handled, its particular specifications and task.

The feed product is evenly distributed by the rotor and its wipers over the heating surface, forming a thin liquid film of uniform thickness. Highly turbulent swirls are produced at the tip of the rotor blades and wipers with intensive mixing and agitation of the product, as it comes into contact with the heating surface. This assures excellent heat transfer combined with constant renewal of the product film and provides an even heating and short residence time of the product through the heated zone.

2-213

ETP DIAGRAM

For Distilled For Low COD

Oil & Grease Chamber

Equalization Tank No.1 Equalization Tank No.2

Flash Mixture

RO Plant

Sludge Tank

Decanter

Aeration Tank no.1 Aeration Tank no.2

Secondary Clarifier Secondary Clarifier

Tertiary Treatment (Flocculation)

Tube Settler

Hold Up Tank

Filter Press

Sand Filter

Carbon Filter

Primary Clarifier No.1 Primary Clarifier No.2

Bio Tower Feed Tank/ Primary Collection Tank

Bio Tower

Sludge

Screen Chamber

Treated Effluent Tank

Sludge Tank

Decanter

Sludge

Primary Settling Tank.1

Anoxic Tank

Oil & Grease Chamber

Equalization Tank A No.1 Equalization Tank B No.2

Flash Mixture 1&2

Aeration Tank no.1

Secondary Settling tank-1

Aeration Tank no.2

Secondary Settling tank-2

Filter Feed Tank

Sand Filter

Carbon Filter

R.O Plant

2-214

RO FOR LOW COD EFFLUENT (Existing)

RO FOR LOW COD EFFLUENT (Proposed)

2-215

MEE FOR HIGH COD EFFLUENT

1. High COD (>15000 ppm) taken to Solvent Stripper before Putting into MEE 2. Capacity 100 KL/day 3. 5 Stage Forced Circulation system 4. Fresh steam condensate recycled 5. Low TDS Distilled water reused in plant for CT 6. 4‐5% solid Concentrate Mass comes out as waste, which being incinerated in‐house Standard Operating Procedure for Stripper operation as follows:

o The cooling tower Supply to the Main Condenser shall be on and required pressure shall be available.

o The Steam supply pressure shall be around kg/cm2g. o Condensate shall completely drain the external Forced circulation re‐boiler. o All drain and sample valves shall be closed. o Fill the bottom portion column with the effluent to around 45% of the total range of the

Level in the Level gauge. Ensure that the level in the column is below the re‐circulation line of the External re‐boiler of the Column.

o Start the Re‐circulation pump of the External forced circulation re‐boiler. o Slowly start the stream supply to External re‐boiler and start heating the content.

Observed the bottom temperature of the Column, it will gradually rise from ambient temperature to around 105 0C, and then it will be become almost constant.

o Observed the top vapor temperature this will reach to around 80‐950C on reaching temperature the condensation will start in the Main condenser.

o Keep the column under the total reflux. The top vapour temperature will gradually drop to 70‐750C.

o Keep the column under the total reflux till column stabilizes. At the Steady state the Top vapour

o Temperature shall be around 70‐750C while bottom temperature shall be around 102‐1050C. Top of the column shall be mixture of solvents with water while bottom of the column shall be Effluent with around 1000ppm Solvents.

o Start the continuous feed to the column at the step of 200 kg/hr till the desired rate. The Reflux ratio shall be 1:5:1

o Adjust the reflux to maintain the column Top temperature. The water content in the Top distillate can be reduced y only increasing the Reflux to the column.

o Adjust steam supply to the column maintain bottom temperature of the column i.e. the bottom concentration of solvents in the effluent around 1000ppm.

o The Distillate to be withdrawal in such way that reflux drum is filled 25% at any time, this is to ensure continuous reflux to the column and also for the safety of the pump.

2-216

o The feed needs to be preheated through the pre‐heater to reduce the steam consumption. During the operation following needs to be maintained constant / to be monitored:

o Top Temperature o Bottom Temperature o Level in the bottom portion of the column o Level in the Reflux drum o Observe the parameter of continuous running stripper plant and recorded in stripper o Column Log Sheet Standard Operating Procedure for MEE Operation o Check the MEE inlet tank effluent level and pH & total Solid of feed effluent before start

up activity of MEE Plant. o Switch on the main switch of control panel. o Start the cooling tower basin & fill with sufficient water. � Start on the seal water supply

pump. o Start the cooling water pumps and open the entire inlet &out let valves. o Close the all discharge valves of pumps open to the atmosphere to avoid leakage in the

system. o Before opening any steam valve please ensure the system pressure should be 2.5kg/cm2. o Start vacuum pump initially and after 10‐15 minutes open the Y stage ejector respectively

to vacuum the evaporation plant. o Wait till 680 mmHg (g) vacuums will reach the system vacuum gauge. o Ensure normal level effluent in feed tank with the average 3.5% TDS. o Start feed P‐01and adjust the feed rate to 5000 kg/hrs for five effects. o Observed the liquid level in vapor separator. Start recirculation pump after achieving

level. o After level achieves start jet ejector for Evaporator. o Start steam in the Calandria. Start to transfer partial feed from recirculation pump to

liquid out let of vapour separator‐1. o Observed the level of all vapour separators. The level of all vapour separators should be

above 1st sight glass. o Start the re‐circulation pumps respectively. o Open the steam valve for starting of evaporation procedure. o Adjust feed rate (2000‐5000 kg/hr) for initial half an hr. o Start the condensate pump P‐010 and P‐09 respectively & open the discharge valve. o Start the condensate pump‐07 and open the discharge valve. o Highly concentrate liquid goes to settler and overflow goes to BT—2. o When salt formation start, highly concentrate liquid goes in centrifuge through settler and

filtrate goes in BT‐2 through pump‐011 or storage tank. o If there is a floating polymerized sticky mass observed on the top of settler, remove the

same and send in to incinerator for incineration.

2-217

o After adequate loading of slurry in centrifuge stop feeding and allow in to run for 15‐20 min. for removal of liquid material from the centrifuge.

o Stop centrifuge and remove solid salts from centrifuge and fill in it bags and send in to specified storage area or incinerator for incineration.

o Observe the parameter of continuous running plant and record in MEE Plant Log sheet.

DIAGRAM OF MEE

PROCEDURE FOR INCINERATOR OPERATION o All hazardous waste collected for incineration shall be transferred to incinerator as per

the requirement of incineration on the basis of calorific value of the waste. o Check furnace oil level in F.O. storage tank at incinerator and transfer F.O. from main

storage tank to incinerator tank, if level of F.O. is less than 1 K.L. o Start furnace oil pre heating by starting switch from panel room. o Prepare 5 % caustic solution in caustic solution tank by adding 25 Kgs caustic flakes in 500

lits of water .Start stirrer of caustic preparation tank and allow it to run till entire quantity of caustic flakes gets dissolved in water.

o Check level of scrubber tank and quencher tank and if require make up the level of both the tanks with caustic solution.

o Ensure proper removal of the ash from primary combustion chamber before loading waste for the next batch.

o Start firing of secondary combustion chamber to attain required temperature before start firing in primary combustion chamber.

2-218

o Charge hazardous solid waste i.e. mix of ETP sludge/spent carbon/filter & filter material/off specification product & date expired material/spent solvent/distillation residue in the primary combustion chamber as per the designed quantity at the beginning of the batch.

o Close main door of the primary chamber and upon attaining required temperature of the F.O. start firing of the primary combustion chamber.

o Start feed of mother liquor (MEE Concentrate ‐ Aqueous waste) after achieving 650 ºC temperature in primary combustion chamber @ of max. 500 Lits/Hr.

o Adjust air & aqueous waste feed ratio such a way by which proper combustion takes place in the primary combustion chamber. Also ensure that aqueous waste should not come out from the back door of primary combustion chamber from where ash is removed after incineration.

o After every hour load 50 Kgs. Solid hazardous waste as in to the primary combustion chamber on the basis of calorific value by opening main door of the primary combustion chamber. Before opening main door stop firing of the primary burner and close aqueous waste loading valve.

o Close main door of the primary combustion chamber and start firing of primary burner and after attaining temperature start aqueous waste loading in primary combustion chamber.

o Continue the hazardous solid waste and aqueous waste combustion process till required level of ash gets accumulated in the primary chamber. Stop aqueous waste feeding one hour prior to the stoppage of incinerator batch & mix bunt waste thoroughly by opening doors of the primary chamber to ensure complete combustion of the waste.

o Stop secondary burner after primary burner and allow the scrubber, quencher and I.D. fan to run continuously for 2‐3 hr. to bring down temperature of the entire incinerator system.

o Remove ash from the primary chamber after getting temperature <150 ºC. o Transfer ash to designated ash storage area after filling in bags. o Use proper PPEs while working at incinerator. o There should not be any spillage/leakage/overflow of the material/waste at incinerator to

maintain proper housekeeping of that area. o Also start the switch of gas analyzer unit. o Records data of incinerator running plant in format no: EN/P/003‐F01. o Record the gaseous emission result in format no: EN/P/003‐F02.

2-219

DIAGRAM OF INCINERATOR

CHARACTERISTICS OF EFFLUENT

SR. NO.

PARAMETER INLET OUTLET

1 pH 6.78 8.04

2 TSS (mg/L) 324 88 3 TDS (mg/L) 7090 1442

4 Oil & Grease (mg/L) < 0.4 <0.4

5 BOD (mg/L) 1892 <1.0

6 COD (mg/L) 5003.2 <10.0 7 Ammonical Nitrogen (mg/L) 110.3 22.7

8 Chlorides (mg/L) 3077 414.9

9 Sulphate (mg/L) 773.5 245.2

2-220

2.4.4 AIR POLLUTION AND CONTROL SYSTEM

FLUE GAS EMISSION STACK

NO. STACK ATTACHED

TO FUEL FUEL

COSNUMPTION STACK

HEIGHT APMCM

1 Agro based Boiler 5 TPH

Agro‐waste/ Briquettes

1015 kg/hr 35 M Bag Filter

2 Water Tube FBC Boiler 10 TPH

Imported steam Coal

1500 kg/hr 35 M ESP(Dry Horizontal type with 3 field)

3 Boiler 1 & 2 (2 TPH) FO 180 Lit/hr 30 M Scrubber

4 D.G.Set (750 KVA) HSD/LDO 170 Lit/hr 12 M ‐‐

5 Incinerator FO 15 Lit/hr 38 M Quencher & Alkali Scrubber

6 Thermic Fluid Heater

LDO 0.4 KL/Month 12 M ‐‐

PROCESS EMISSION

STACK NO.

STACK ATTACHED TO STACK HT. PROBABLE

POLLUTANTS AIR POLLUTION

CONTROL PERMISSIBLE LIMIT

1 Reaction Vessels Pilot Plant 12 M HCl Cl

2

Alkali Scrubber 20 mg/Nm3

9 mg/Nm3

2 Reaction Vessels No‐1 in Plant‐1 (Replaced)

12 M NH3 Chilled Water

Circulation 175 mg/Nm

3

3 Reaction Vessels No‐2 in Plant‐1 (Replaced)

12 M HCl Cl

2


9 mg/Nm3

4 Reaction Vessels in Plant‐2 12 M HCl Cl

2


9 mg/Nm3


2


9 mg/Nm3


2


9 mg/Nm3

7 Reaction Vessels No‐2 in Plant‐2



3




3


12 M HCl Cl

2


9 mg/Nm3

10 Reaction Vessels No‐1 in Ware‐House

12 M HCl Cl

2


9 mg/Nm3

2-221

2.4.5 NOISE LEVEL AND CONTROL SYSTEM

Extensive oiling and lubrication and preventive maintenance shall be carried out to reduce

noise generation at source to the permissible limit. However, at place where noise levels can

exceed the permissible limit, Earplugs and Earmuffs are provided to those working in such area.

2.4.6 HAZARDOUS WASTE GENERATIONS AND DISPOSAL SYSTEM

Twelve Categories of Hazardous/Solid Wastes shall be generated from this Unit. Hazardous

waste generation will be Used Oil, Spent Solvent, Process Residue, Spent carbon & Hyflow,

Spent Mother Liquor, Discarded Drums, ETP Sludge, Filler & Filter Material, Incinerator Ash, Off

Specification Product / Date Expired Product & Evaporation Salt. All the Solid/Hazardous Waste

generated will be disposed as per the norms. Hazardous waste generation quantity, physical

characteristics and mode of disposal are given in Table‐2.3.

2-222

TABLE‐2.3

DETAILS OF HAZARDOUS WASTE AND ITS MODE OF DISPOSAL EXISTING

Sr. No

Waste Category

No. Unit

Existing Quantity

Treatment /Disposal

1 Used Oil 5.1 KL/YR 6.96 Collection, storage, Transportation & disposal by selling to register refiners

2 Spent solvent 28.5 KL/YR 1020

Collection, storage, Transportation, on‐site/off‐site distillation or Sale to authorized recycler

3 Process Residue 36.4 KL/Year 120 Collection, storage, Transportation & Incineration

4 Spent carbon &

Hyflow 28.2 MT/YR 60

Collection, storage, Transportation & Incineration

5 Spent Mother

Liquor 28.1 KL/YR 16200

Collection, storage, Treatment in ETP, MEE, ATFD or incineration

6 Discarded Drums 33.3 Nos/YR 36000 Collection, storage, decontamination & reuse

7 ETP Sludge 34.3 MT/YR 150 Collection, storage, Transportation & Disposed at M/s. NECL

8 Filler & Filter

Material 35.1 Nos/YR 18600

Collection, storage, Transportation & disposal by incineration

9 Incinerator Ash 36.2 MT/YR 70 Collection, storage, Transportation & Disposed at M/s. NECL

10 Off Specification Product / Date

Expired Product 28.4 KG

So ever granted

Collection, storage, transportation & disposal by incineration within premises.

2-223

LIST OF HAZARDOUS WASTE (TOTAL AFTER PROPOSED EXPANSION)

SN Type of Waste Cat. No. Unit Generation Mode of Disposal

Proposed

1 Used Oil 5.1 KL/YR 7.96 Collection, storage, transportation, disposal by sale to authorized re‐refiner

2 Spent solvent 28.5 KL/YR 1500

Collection, storage for Onsite Distillation OR transportation for off site distillation at Vadodara Unit (Alembic Limited) OR by authorized vendor OR Sale to authorized recycler

3 Process Residue 36.4 KL/Year 360 Collection, storage, transportation & disposal by incineration at CHWIF or send for co‐processing in cement industries

4 Spent carbon 28.2 MT/YR 180 Collection, storage, transportation & disposal by incineration at CHWIF or send for co‐ processing in cement industries

5 Spent Mother

Liquor 28. 4 KL/YR 30600

Collection, storage, onsite treatment in MEE ATFD & incineration OR transportation & disposal by incineration at CHWIF or send for co‐ processing in cement industries

6 Discarded

Drums 33.3 Nos/YR 40000

Collection, storage, decontamination & reuse or sale to authorized recycler

7 ETP sludge 34.3 MT/YR 650 Collection, storage, transportation & disposal at TSDF

8 Filler & Filter

Material 35.1 Nos/YR 20000

Collection, storage, transportation & disposal by incineration on‐site or off‐site

9 Incinerator Ash 36.2 MT/YR 100 Collection, storage, transportation & disposal at TSDF

10 Off Specification Product / Date

Expired Product 28.4 KG

So ever granted

Collection, storage, transportation & disposal by incineration within premises or at CHWIF

11 Evaporation Salt 29.2 MT/YR 450 Collection, storage, transportation & disposal at TSDF

12 Fly Ash ‐ MT/Day 1.5 Collection, storage, transportation & disposal at TSDF or send for co‐processing in cement industries

2-224

CHARACTERISTICS OF ETP SLUDGE

SR. NO.

PARAMETER RESULTS

1 Moisture Contents 18.10 %

2 Total Solids Contents 81.9 %

3 pH 7.83

4 Total Inorganic Solids 81.2 %

5 Total Organic Solids 18.8 %

6 COD 3914.4 mg/Kg 7 Chlorides 1120.4 mg/Kg

8 Sulphates 656.2 mg/Kg 9 Total Alkalinity (as CaCO3) 300.0 mg/Kg

10 Total Iron (as Fe) BDL

11 Copper (as Cu) BDL

12 Lead (as Pb) BDL

2.5 DETAILS OF UTILITIES

Various utilities required for proper functioning of manufacturing plants. These utilities include

boiler, cooling plant, Cooling tower, DM water plant, Chilling Plant & Brine Unit, Air

compressor, High Vacuum System, etc.

2.6 ELECTRICITY & FUEL REQUIREMENT

FLUE REQUIREMENT (EXISTING)

STACK NO. EQUIPMENT FUEL FUEL COSNUMPTION

1 Agro based Boiler 5 TPH Agro‐waste/ Briquettes

1015 kg/hr

2 Boiler 1 & 2 (2 TPH) LDO 180 Lit/hr

3 D.G.Set (750 KVA) HSD 170 Lit/hr

4 Incinerator LDO 15 Lit/hr

2-225

FLUE REQUIREMENT (PROPOSED)

STACK NO.

EQUIPMENT FUEL FUEL

COSNUMPTION Per day

FUEL COSNUMPTION Per Month

1 Agro based Boiler 5

TPH Agro‐waste/ Briquettes

1.5 MT 45 MT

2 Water Tube FBC Boiler

10TPH Imported steam

Coal 35 MT 1050 MT

3 Boiler 1 & 2 (2 TPH) FO 0.4 KL 12 KL

4 D.G.Set (750 KVA) HSD/LDO 0.25 KL 0.75 KL

5 Incinerator FO 0.18 KL 5.4 KL

6 Thermic Fluid Heater

LDO 0.4 KL 0.4 KL

POWER REQUIREMENT (EXISTING)

Particular

Consumption (per/Day)

Consumption (per/Month)

Source

1 38732 KWH 1161960 MGVCL

POWER REQUIREMENT (TOTAL AFTER PROPOSED EXPANSION)

Particular

Consumption (per/Day)

Consumption (per/Month)

Source

1 54225 KWH 1626750 MGVCL

Note: DG Set of 750 KVA (1 No. Existing & 1 No. Additional Proposed) will be provided for emergency power backup

3- 1

CHAPTER – 3

BASELINE ENVIRONMENTAL STATUS The baseline status of environmental quality in the vicinity of project site serves as the basis

for identification, prediction and evaluation of impacts. The baseline environmental quality

is assessed through field studies within the impact zone for various components of the

environment, viz. air, noise, water, land and socio‐economic. The baseline environmental

quality has been assessed in the Post‐Monsoon Season of 2014 (October’ 14 to December’

14) in a study area of 5 km radial distance from the project site.

3.1 MICRO‐METEOROLOGY OF THE AREA The climate of Gujarat is varied, as it is moist in the southern districts and dry in the

northern region. The Arabian Sea and the Gulf of Cambay in the west and the forest‐covered

hills in the east soften the rigours of climatic extremes, consequently reducing the

temperature and render the climate more pleasant and healthy. Bharuch lies along the

southern part of the state and experiences a climate with aridity index of 15 to 20 per cent

indicating adequate moisture availability in the soils for most part of the year. (Courtesy:

Environmental Information Centre, New Delhi)

3- 2

3.1.1 TEMPERATURE DETAILS

Minimum, Maximum and Average Temperatures for Vadodara Station of the year 2013‐

2014 are given in Table 3.1.

TABLE 3.1

TEMPERATURE DATA

Month

(2013‐2014)

Minimum

Temperature

(0C)

Maximum

Temperature

(0C)

Average

Temperature

(0C)

October’13 19 36 28

November’13 15 34 24

December’13 11 32 22

January’14 11 32 20

February’14 13 33 23

March’14 34 41 27

April’14 20 39 30

May’14 24 42 32

June’14 24 38 29

July’14 20 34 27

August’14 23 32 27

September’14 23 38 28

3- 3

3.1.2 RELATIVE HUMIDITY (RH)

Minimum, Maximum and Average Monthly Relative Humidity for Vadodara Station of the

year 2013‐2014 are given in Table 3.2.

TABLE 3.2

RELATIVE HUMIDITY DATA

Month

(2013‐2014) Minimum R.H.% Maximum R.H.% Average R.H.%

October’13 19 98 69

November’13 13 95 51

December’13 14 90 53

January’14 11 99 63

February’14 11 99 49

March’14 7 98 37

April’14 7 98 42

May’14 9 97 53

June’14 30 99 75

July’14 36 97 91

August’14 49 98 89

September’14 34 99 81

Relative Humidity values for Vadodara station was recorded & Relative Humidity is generally

high during the period from June to September. The diurnal variations are least during

monsoon season. The diurnal variation is highest during summer period.

3- 4

3.1.3 RAINFALL

Rainfall data for Vadodara Station of the year 2013‐2014 is presented in Table 3.3.

TABLE 3.3

RAINFALL DATA

Month

(2013‐2014)

Monthly Total

(mm) Numbers of Rainy Days

October’13 0 0

November’13 0 0

December’13 0 0

January’14 0 0

February’14 0 0

March’14 0 0

April’14 0 0

May’14 0 0

June’14 10.3 10

July’14 325.8 18

August’14 448 23

September’14 219 14

Total 1003.1 65

Total rainfall, during the monsoon period, has been recorded as 1003.1 mm.

3- 5

3.1.4 WIND SPEED

Wind speed for Vadodara Station of the year 2013‐2014 is given in Table 3.4.

TABLE 3.4

WIND SPEED DATA

Sr. No. Month

(2013‐2014)

Average Wind speed

(KMPH)

1. October’13 2.96

2. November’13 1.59

3. December’13 3.71

4. January’14 5.12

5. February’14 2.93

6. March’14 2.49

7. April’14 4.80

8. May’14 8.01

9. June’14 5.42

10. July’14 5.55

11. August’14 6.95

12. September’14 3.43

Average 4.41

Site‐specific mean meteorological data is given in Table‐3.5.

A meteorological station was installed at the project site to know temperature, relative

humidity, wind speed, wind direction and rainfall at the project site during the study period:

3- 6

TABLE ‐ 3.5 ___________________________________________________________________________ SITE SPECIFIC METEOROLOGICAL DATA (PERIOD – OCTOBER’ 14 TO DECEMBER’ 14)

MONTH METEOROLOGICAL PARAMETER

OCTOBER’ 14 NOVEMBER’ 14 DECEMBER’ 14

Temperature (0C)

Min.

Max.

Avg.

18

36

28

15

32

29

12

32

23

Relative Humidity (%)

Min.

Max.

Avg.

9

100

64

10

85

40

7

95

46

Wind Speed (km/h)

Min.

Max.

Avg.

0

11

3

0

19

6

0

13

5

There was no rainfall during the study period. The wind direction is predominantly from NW to SE. Diurnal shift in wind direction was not

observed during study period. The wind rose diagram prepared from data collected at site is

shown in Figure 3.1A, while stability class diagram is shown in Figure 3.1B

3- 7

WRPLOT View - Lakes Environmental Software

WIND ROSE PLOT:

M/s. Alembic Pharmaceuticals Limited (Unit-I)

PROJECT NO.:

COMMENTS:

MODELER:

COMPANY NAME:

M/s. Alembic Pharmaceuticals Limited (Unit-I)

NORTH

SOUTH

WEST EAST

4%

8%

12%

16%

20%

WIND SPEED (m/s)

>= 11.1

8.8 - 11.1

5.7 - 8.8

3.6 - 5.7

2.1 - 3.6

0.5 - 2.1

Calms: 27.26%

TOTAL COUNT:

2208 hrs.

CALM WINDS:

27.26%

DATA PERIOD:

2014 Oct 1 - Dec 3100:00 - 23:00

AVG. WIND SPEED:

1.62 m/s

DISPLAY:

Wind SpeedDirection (blowing from)

FIGURE‐3.1A

WIND ROSE DIAGRAM

3- 8

11.4

78.4

7.82.4

0

10

20

30

40

50

60

70

80

90

%

Wind Class Frequency Distribution

Wind Class (m/s)Calms 0.5 - 2.1 2.1 - 3.6 3.6 - 5.7 5.7 - 8.8 8.8 - 11.1 >= 11.1

12.811.5

7.5 7.69.1

40.1

0

5

10

15

20

25

30

35

40

45

%

Stability Class Frequency Distribution

Stability ClassA B C D E F

FIGURE‐3.1B

STABILITY CLASS DISTRIBUTION

3- 9

3.2 AIR ENVIRONMENT

3.2.1 DESIGN OF NETWORK FOR AMBIENT AIR QUALITY MONITORING LOCATIONS

The air quality status in the impact zone is assessed through a network of ambient air

quality monitoring locations. The tropical climatic conditions mainly control the transport

and dispersion of air pollutant emissions during various seasons.

The baseline studies for air environment include identification of specific air pollutants prior

to implementation of the project. The Environmental Impact Assessment (EIA) study

requires monitoring of baseline ambient air quality during one season. Accordingly, ambient

air quality monitoring was carried out in the post‐monsoon season from Oct. 1, 2014 to Dec.

31, 2014. The main sources of air emissions in the study area are industrial operations,

vehicular emission, dust from paved and unpaved tracks, fuel burning for domestic purpose,

and wind blown dust from open land.

Eight Ambient Air Quality Monitoring (AAQM) locations were selected based on guidelines

of ambient air quality network siting criteria of CPCB. All AAQM locations were selected

within the study area of 5 km radial distance from the project site covering all zones i.e.

industrial, residential, rural & other area as per NAAQS and keeping in mind local

topography and meteorology of the area.

3- 10

3.2.2 METHODOLOGY FOR AMBIENT AIR QUALITY MONITORING

The ambient air quality monitoring was carried out in accordance with National Ambient Air

Quality Standards (NAAQS) of CPCB. Ambient Air Quality Monitoring (AAQM) was carried

out at ten locations during the study period. The locations of the different stations with

respect to its distance and direction from project site are shown in Table‐3.6 and Figure‐3.2

respectively.

The conventional and project specific parameters such as Suspended Particulate Matter,

Respirable Suspended Particulate Matter (RSPM‐PM10), Respirable Suspended Particulate

Matter (RSPM‐PM2.5), Sulphur Dioxide (SO2), Oxides of Nitrogen (NOx), Ozone (O3), Lead

(Pb), Carbon Monoxide (CO), Ammonia (NH3), Benzene (C6H6), Benzo (a) Pyrene (BaP),

Arsenic (AS), Nickel (Ni), Chlorine (Cl2), HCl, HC & VOCs were monitored at site.

The values for mentioned concentrations of various pollutants at all the monitoring

locations were processed for different statistical parameters like arithmetic mean, minimum

concentration, and maximum concentration and percentile values. The existing baselines

levels of Suspended Particulate Matter, Respirable Suspended Particulate Matter (RSPM‐

PM10), Respirable Suspended Particulate Matter (RSPM‐PM2.5), Sulphur Dioxide (SO2),

Oxides of Nitrogen (NOx), Ozone (O3), Lead (Pb), Carbon Monoxide (CO), Ammonia (NH3),

Benzene (C6H6), Benzo (a) Pyrene (BaP), Arsenic (AS), Nickel (Ni), Chlorine (Cl2) ), HCl, HC &

VOCs are expressed in terms of various statistical parameters as given in Tables‐3.7 National

ambient air quality standards are enclosed as Annexure‐1.

3- 11

TABLE ‐ 3.6

___________________________________________________________________________

DETAILS OF AMBIENT AIR QUALITY MONITORING LOCATIONS

SR.

NO.

NAME OF VILLAGE BEARING

W.R.T.

PROJECT

SITE

APPROXIMATE RADIAL

DISTANCE FROM PROJECT

SITE (KM)

TYPE

OF

AREA

1 Project‐site (A1) ‐‐‐ ‐‐‐ Industrial

2 Panelav (A2) W 1.48 Residential

3 Vanseti (A3) SW 1.67 Residential

4 Tajpura (A4) SE 1.48 Residential

5 Gopipura (A5) N 0.93 Residential

6 Baska (A6) NW 2.04 Residential

7 Ujeti (A7) SW 2.22 Residential

8 Nurpura (A8) NNW 2.04 Residential

3- 12

FIGURE ‐ 3.2 ___________________________________________________________________________ LOCATION OF AMBIENT AIR QUALITY MONITORING STATIONS

3- 13

TABLE 3.7 ___________________________________________________________________________ AMBIENT AIR QUALITY STATUS (Oct., 2014 to Dec., 2014) Unit: µg/m3

SPM PM10 PM2.5 SO2 NOx O3 SR. NO.

SAMPLING LOCATION AVERAGE

1 Project‐site (A1) 120.54 78.92 44.08 12.72 14.12 11.25

2 Panelav (A2) 105.66 75.53 41.67 11.98 12.46 10.69

3 Vanseti (A3) 113.51 80.80 45.48 13.09 13.85 11.42

4 Tajpura (A4) 124.29 87.36 42.68 12.89 14.08 10.74

5 Gopipura (A5) 131.95 89.26 40.36 14.25 15.37 12.16

6 Baska (A6) 109.08 78.87 39.68 10.49 11.52 10.41

7 Ujeti (A7) 118.80 80.18 45.29 11.68 13.47 12.05

8 Nurpura (A8) 110.50 76.76 42.63 10.94 12.78 11.27

TABLE 3.7 (CONTD.) ___________________________________________________________________________ AMBIENT AIR QUALITY STATUS (Oct., 2014 to Dec., 2014) Unit: µg/m3

Pb NH3 CO (mg/m3)

C6H6 BaP (ng/m3)

As (ng/m3)

Ni (ng/m3)

SR. NO.

SAMPLING LOCATION

AVERAGE 1 Project‐site (A1) BDL 3.41 1.18 BDL BDL BDL BDL

2 Panelav (A2) BDL 2.52 1.15 BDL BDL BDL BDL

3 Vanseti (A3) BDL 4.52 BDL BDL BDL BDL BDL

4 Tajpura (A4) BDL 3.97 BDL BDL BDL BDL BDL

5 Gopipura (A5) BDL 4.64 BDL BDL BDL BDL BDL

6 Baska (A6) BDL 2.52 1.17 BDL BDL BDL BDL

7 Ujeti (A7) BDL 3.93 BDL BDL BDL BDL BDL

8 Nurpura (A8) BDL 2.11 1.16 BDL BDL BDL BDL

Note: BDL: Below Detectable Limit

3- 14

TABLE 3.7 (CONTD.) ___________________________________________________________________________ AMBIENT AIR QUALITY STATUS (October‐14 to December‐14) Unit: µg/m3

HCl Cl2 HF HC

(ppm)

VOCs (Isobutylene Equivalent) (ppm)

SR. NO.

SAMPLING LOCATION

AVERAGE 1 Project‐site (A1) BDL BDL BDL BDL 1.3 2 Panelav (A2) BDL BDL BDL BDL 1.0 3 Vanseti (A3) BDL BDL BDL BDL 0.6 4 Tajpura (A4) BDL BDL BDL BDL 0.8 5 Gopipura (A5) BDL BDL BDL BDL 0.7 6 Baska (A6) BDL BDL BDL BDL 0.8 7 Ujeti (A7) BDL BDL BDL BDL 0.4 8 Nurpura (A8) BDL BDL BDL BDL 0.5

Note: BDL – Below Detectable Limit Note:

PARAMETER TEST METHOD Particulate Matter (PM10) IS 5182 (PART 23):2006 (Cyclonic Flow Technique) Gravimetric Particulate Matter (PM2.5) Gravimetric Sulphur Dioxide (SO2) IS 5182 (PART‐2):2001 Nitrogen Dioxide (NO2) IS 5182 (PART‐6):2006 Ozone (O3) IS 5182 (PART‐9) :1974 **Lead (Pb) AAS APHA 3030 E Ammonia (NH3) Indophenol Blue Method *Carbon Monoxide (CO) Digital CO Analyzer **Benzene (C6H6) Adsorption extraction followed by GC/GCMS **Benzo (α) Pyrene (BaP) Solvent extraction followed by GC/GCMS **Arsenic (As) AAS APHA 3114 B‐ C **Nickel (Ni) AAS APHA 3030 E **Hydro Carbon (HC) Digital Gas Analyzer Hydrogen Sulphide (H2S) IS 5182 (PART‐7):1973 *Hydrochloric Acid(HCl) Titrametric Method

Chlorine (CL2) IS:5182:(PART‐19):1982 *Hydrogen Fluoride (HF) IS:5182:(PART‐13):1991

Carbon Disulphide (CS2) IS:5182:(PART‐20):1982 VOC – Aeroqual Series 300 (Sensor 0 – 25 ppm) Minimum Detectable Limit – 0.1 ppm Minimum Detection Limit: **Lead (as Pb) : 0.5 µg/m3 **Benzo (α) Pyrene (BaP) : 0.5 ng/m3 Ammonia (NH3) : 1 µg/m3 **Arsenic (as As) : 2 ng/m3 Carbon Monoxide(as CO) : 1.14 mg/m3 **Nickel (as Ni) : 10 ng/m3 **Benzene (as C6H6) : 2 µg/m3 **Hydrocarbon(HC) : 1 ppm HCl : 1 µg/m3 Cl2

: 5 µg/m3 HF : 1 µg/m3 *Not in our NABL Scope, **Analysed by Sub Contractor (Not in our NABL Scope)

3- 15

TABLE 3.7 (CONTD.) ___________________________________________________________________________ AMBIENT AIR QUALITY STATUS‐ 98TH PERCENTILE VALUE (24 HRS.) (OCT, 2014 TO DEC, 2014) Unit: µg/m3

SR. NO.

SAMPLING LOCATION

PM10 PM2.5 SO2 NOx O3

1. Project‐site (A1) 83 48 16 19 15

2. Panelav (A2) 80 44 15 16 14

3. Vanseti (A3) 84 49 17 17 15

4. Tajpura (A4) 91 44 16 19 14

5. Gopipura (A5) 94 44 19 19 16

6. Baska (A6) 83 45 14 15 14

7. Ujeti (A7) 84 49 15 17 16

8. Nurpura (A8) 80 44 14 16 15 NAAQS Limit 100 60 80 80 100

3- 16

3.3 NOISE ENVIRONMENT

The objective of the noise pollution survey around the project site was to identify existing

noise sources and to measure background noise levels. Major noise sources in the study

area are industries, commercial, and vehicular movements. The noise monitoring locations

are given in Table‐3.8A and shown in Figure‐3.3 while the results of noise monitoring are

given in Table 3.8B.

3.3.1 METHODOLOGY FOR NOISE MONITORING

The noise monitoring was carried out at eight locations in day time during (6 am to 9 pm)

and at night time (9 pm to 6 am) in the study area covering all the areas i.e. industrial,

commercial, residential and silence zones as mentioned in Noise (Pollution and Control)

Rules, 2000. CPCB Recommendations for community noise exposure are attached as

Annexure – 3. Hourly Equivalent noise levels Leq (day) and Leq (night) were measured at

each monitoring locations. One day monitoring during Nov. 24 to 27, 2014 during day and

night time was carried out at all the locations. Besides, damage risk criteria for hearing loss

given by Occupational Safety & Health Administration (OSHA) are enclosed as Annexure ‐ 2.

The noise level measured in study area at different locations is given in Table 3.8. The noise

sources identified around the site are vehicular traffic, industrial and commercial activities.

CPCB recommendation for community noise exposure in different category of area (i.e.

residential, commercial, industrial and silence zone) is enclosed as Annexure ‐ 3 while

Damage risk criteria for hearing loss given by occupational safety & health administration

(OSHA) is enclosed as Annexure ‐ 2. The noise levels were below the stipulated standards of

CPCB.

Noise levels due to transportation were also measured at three different locations. The

equivalent noise level Leq (60 min average) measured at a distance of 10 m and 20 m from

the edge of the road at each of the locations are presented in Table 3.9. The communities

close to the project site are not exposed to major noise sources. The commercial activities

and transport apart from natural sources contribute to community noise levels.

3- 17

TABLE ‐ 3.8A

DETAILS OF AMBIENT NOISE QUALITY MONITORING LOCATIONS

SR.

NO.

NAME OF

VILLAGE

BEARING W.R.T.

PROJECT SITE

APPROXIMATE RADIAL

DISTANCE FROM PROJECT

SITE (KM)

1 Project‐site (N1) ‐‐‐ ‐‐‐

2 Panelav (N2) W 1.48

3 Vanseti (N3) SW 1.67

4 Tajpura (N4) SE 1.48

5 Gopipura (N5) N 0.93

6 Baska (N6) NW 2.04

7 Ujeti (N7) SW 2.22

8 Nurpura (N8) NNW 2.04

3- 18

FIGURE ‐ 3.3 __________________________________________________________________________ LOCATION OF AMBIENT NOISE LEVEL MONITORING STATIONS

3- 19

TABLE ‐ 3.8B ___________________________________________________________________________ BACKGROUND NOISE LEVELS

SR. NO.

LOCATION NOISE LEVEL IN DBA TIME

1 Project‐site (N1) 50‐54 38‐40

Day Night

2 Panelav (N2) 50‐54 38‐41

Day Night

3 Vanseti (N3) 50‐52 38‐42

Day Night

4 Tajpura (N4) 51‐53 39‐42

Day Night

5 Gopipura (N5) 49‐52 40‐42

Day Night

6 Baska (N6) 50‐54 38‐40

Day Night

7 Ujeti (N7) 50‐53 43‐45

Day Night

8 Nurpura (N8) 39‐41 39‐43

Day Night

TABLE ‐ 3.9 ___________________________________________________________________________ NOISE LEVELS DUE TO TRANSPORTATION

SR. NO.

SAMPLING LOCATION

NOISE LEVEL IN DBA TIME

1. N1(T): Near Panelav Bypass 62‐64 51‐53

Day Night

2. N2 (T): Near Vanseti Bypass 60‐63 51‐52

Day Night

3. N3 (T): Near Tajpura Bypass 61‐63 53‐54

Day Night

4. N4 (T): Near Baska Cross Road 61‐64 52‐54

Day Night

5. N5 (T): Near Ujeti Bypass 60‐62 51‐54

Day Night

3- 20

TABLE ‐ 3.9 (CONTD.) ___________________________________________________________________________ INDUSTRIAL NOISE LEVELS

SR. NO.

SAMPLING LOCATION

NOISE LEVEL IN DBA TIME

1. Nr. Anmol Antioxidants Pvt. Ltd. 63‐68 61‐63

Day Night

2. Nr. UPL Limited (Unit‐4) 59‐63 59‐61

Day Night

3. Nr. Paushak Limited 65‐69 63‐67

Day Night

4. Nr. Baroda Agrochemicals Ltd. 63‐67 63‐65

Day Night

5. Nr. N. Mohanlal Rail Track (P) Ltd. 62‐64 60‐62

Day Night

6. Nr. Aims Industries Ltd. 66‐69 62‐66

Day Night

7. Nr. Energy Pack Boilers Pvt. Ltd. 64‐67 60‐64

Day Night

8. Nr. Unimed Technologies Ltd. 66‐70 61‐66

Day Night

9. Nr. Avani Petrochem Pvt. Ltd. 65‐68 62‐65

Day Night

3- 21

3.4 WATER ENVIRONMENT

3.4.1 RECONNAISSANCE

The average annual rainfall in the region is about 1003.1 mm. The baseline water quality

status in the region is established by analyzing surface water and ground water. Water

requirement at site would be met through ground water supply.

3.4.2 METHODOLOGY FOR WATER QUALITY MONITORING

Eight nos. of ground water and two nos. of surface water samples were collected from the

study area. These samples were analyzed for physic‐chemical parameters to ascertain the

baseline status in the existing surface water and ground water bodies. Samples were

collected once, during Nov. 24 to 29, 2014, during the study period and analyzed as per

standard methods of water and wastewater analysis (APHA). The Indian standard

specification for drinking water IS: 10500‐1993 and CPCB water use criteria are enclosed as

Annexure – 5 & 6 respectively. The details of surface and ground water sampling locations

are given in Table 3.10. And sampling locations of water quality monitoring are shown in

Figure 3.4. The Indian standard specification for drinking water is enclosed as Annexure – 5.

The physico‐ chemical characteristics of the different water samples are presented in the

Tables 3.11.

3- 22

TABLE – 3.10 SAMPLING LOCATIONS FOR MONITORING SURFACE AND GROUND WATER QUALITY

SR.

NO.

SAMPLING

LOCATIONS

BEARING

W. R.T.

PROJECT

SITE

APPROXIMATE

RADIAL DISTANCE FROM

PROJECT SITE

(KM)

1 Project‐site (GW1) ‐‐‐ ‐‐‐

2 Panelav (GW2) W 1.48

3 Vanseti (GW3) SW 1.67

4 Tajpura (GW4) SE 1.48

5 Gopipura (GW5) N 0.93

6 Baska (GW6) NW 2.04

7 Ujeti (GW7) SW 2.22

8 Nurpura (GW8) NNW 2.04

9 Narmada Canal (SW1) SW 3.68

10 Panelav Pond (SW2) NW 0.83

GW= Ground water, SW= Surface water

3- 23

FIGURE ‐ 3.4 __________________________________________________________________________ LOCATIONS OF WATER SAMPLING STATIONS

3- 24

TABLE ‐ 3.11 WATER QUALITY‐ PHYSICAL PARAMETERS

SR.

NO.

SAMPLING

LOCATION

pH TEMPERATURE

(0C)

TURBIDITY

(NTU)

T.D.S.

(mg/L)

T.S.S.

(mg/L)

1 Project‐site (GW1) 7.12 24.9 0.2 398 30

2 Panelav (GW2) 7.06 24.9 0.3 1080 30

3 Vanseti (GW3) 7.60 24.9 0.3 610 20

4 Tajpura (GW4) 7.50 25.1 0.2 406 22

5 Gopipura (GW5) 7.53 25.0 0.2 396 20

6 Baska (GW6) 7.27 24.8 0.3 990 30

7 Ujeti (GW7) 7.41 25.1 0.3 860 24

8 Nurpura (GW8) 7.53 25.0 0.2 346 26

9 Narmada Canal (SW1) 7.73 24.9 0.2 154 22

10 Panelav Pond (SW2) 7.45 25.0 0.2 400 24


TABLE ‐ 3.11 (CONTD.) WATER QUALITY ‐ NUTRIENTS, OXYGEN DEMAND AND ORGANIC PARAMETERS

NITRATE ‐

NITROGEN

TOTAL

PHOSPHO

ROUS

DO COD BOD327 OIL &

GREASE

SR.

NO.

SAMPLING LOCATION

(mg/L)

1 Project‐site (GW1) 3.79 BDL 6.72 2.64 <1.0 <0.4

2 Panelav (GW2) 3.17 BDL 5.12 3.31 <1.0 <0.4

3 Vanseti (GW3) 8.12 BDL 5.82 10.6 <1.0 <0.4

4 Tajpura (GW4) 5.61 BDL 6.34 2.64 <1.0 <0.4

5 Gopipura (GW5) 3.13 BDL 6.56 7.27 <1.0 <0.4

6 Baska (GW6) 11.2 BDL 5.86 6.61 <1.0 <0.4

7 Ujeti (GW7) 8.34 BDL 5.98 3.31 <1.0 <0.4

8 Nurpura (GW8) 6.99 BDL 6.46 5.29 <1.0 <0.4

9 Narmada Canal (SW1) 1.72 BDL 7.08 6.61 <1.0 <0.4

10 Panelav Pond (SW2) 2.78 BDL 6.94 18.5 <1.0 <0.4


3- 25

TABLE ‐ 3.11 (CONTD.) WATER QUALITY ‐ INORGANIC PARAMETERS

GW= Ground water, SW= Surface water T.H. =Total Hardness, C.H. =Calcium Hardness TABLE ‐ 3.11 (CONTD.) WATER QUALITY ‐ HEAVY METALS

Na T‐Cr+3 Cu Cd Fe Zn K Ni As SR. NO.

SAMPLING LOCATION (mg/L)

1 Project‐site (GW1) 47.0 0.0016 BDL 0.0109 0.94 0.0332 1.6 BDL BDL

2 Panelav (GW2) 40.1 <0.001 BDL 0.0141 2.84 0.0278 1.8 BDL BDL

3 Vanseti (GW3) 51.9 <0.001 BDL 0.0113 0.66 <0.02 1.6 BDL BDL

4 Tajpura (GW4) 27.1 <0.001 BDL 0.0052 4.23 0.0383 1.5 BDL BDL

5 Gopipura (GW5) 54.0 <0.001 BDL 0.0096 0.23 <0.02 1.5 BDL BDL

6 Baska (GW6) 80.0 <0.001 BDL <0.003 0.19 <0.02 7.0 BDL BDL

7 Ujeti (GW7) 73.7 <0.001 BDL 0.0042 0.30 <0.02 32.8 BDL BDL

8 Nurpura (GW8) 22.3 <0.001 BDL <0.003 1.52 0.0618 1.4 BDL BDL

9 Narmada Canal (SW1) 11.2 <0.001 BDL BDL 1.52 BDL 1.4 BDL BDL

10 Panelav Pond (SW2) 20.6 <0.001 BDL BDL 1.18 BDL 5.0 BDL BDL

GW= Ground water, SW= Surface water, BDL= Below Detectable Limit Minimum Detection Limit: Copper (as Cu) : 0.05 mg/L **Arsenic (as As) : 0.003 mg/L Total Phosphorous (as P) : 0.01 mg/L Nickel (as Ni) : 0.03 mg/L ** Cadmium (as Cd) : 0.003 mg/L ** Zinc (as Zn) : 0.02 mg/L *Not in our NABL Scope, **Analysed by Sub Contractor (Not in our NABL Scope)

TOTAL

ALKALINITY

(AS CACO3)

T.H.

(AS

CACO3)

C.H.

(AS

CACO3)

Cl‐ SO4—2

Mg SR.

NO.

SAMPLING LOCATION

(mg/L)

1 Project‐site (GW1) 157.5 274 138 37.2 25.6 33

2 Panelav (GW2) 182 844 460 409.5 65.1 93.3

3 Vanseti (GW3) 297.5 506 186 47.2 62.9 77.8

4 Tajpura (GW4) 203 332 196 22.5 14.9 33.5

5 Gopipura (GW5) 206.5 264 140 24.8 51.5 30.1

6 Baska (GW6) 175 672 372 203.5 60.6 72.9

7 Ujeti (GW7) 378 636 220 151.4 41.2 101

8 Nurpura (GW8) 192.5 306 186 14.9 20.7 29.2

9 Narmada Canal (SW1) 77 138 86 12.4 34.8 12.6

10 Panelav Pond (SW2) 84 292 136 124.1 23.5 37.9

3- 26

3.5 LAND ENVIRONMENT

3.5.1 METHODOLOGY FOR SOIL MONITORING

Soil samples were collected from eight different locations during study during Nov. 24 to 29,

2014 in the study area (0‐20 cm depth). The locations selected for collection of soil samples

are shown in Figure 3.5 and presented in Table 3.12. The analysis results of soil samples are

given in Table 3.13.

TABLE ‐ 3.12 ___________________________________________________________________________ SAMPLING LOCATIONS: SOIL QUALITY

SR.

NO.

SAMPLING

LOCATION

BEARING

W.R.T. PROJECT

SITE

APPROXIMATE RADIAL

DISTANCE

FROM PROJECT SITE

(KM)

1 Project‐site (S1) ‐‐‐ ‐‐‐

2 Panelav (S2) W 1.48

3 Vanseti (S3) SW 1.67

4 Tajpura (S4) SE 1.48

5 Gopipura (S5) N 0.93

6 Baska (S6) NW 2.04

7 Ujeti (S7) SW 2.22

8 Nurpura (S8) NNW 2.04

3- 27

FIGURE ‐ 3.5

___________________________________________________________________________

LOCATIONS OF SOIL SAMPLING STATIONS

3- 28

TABLE ‐ 3.13 ___________________________________________________________________________ PHYSICO‐CHEMICALS CHARACTERISTICS OF SOIL

Sr.

No.

Parameter Project

Site (S1)

Panelav

(S2)

Vanseti

(S3)

Tajpura

(S4)

Gopipura

(S5)

Baska

(S6)

Ujeti

(S7)

Nurpura

(S8)

1. pH 7.63 7.87 7.08 7.10 8.42 7.64 7.10 7.67

2. Temperature (0C) 24.8 25.4 25.6 24.8 25.5 25.1 25.8 25.4

3. Moisture (%) 8.10 10.14 6.80 7.90 11.10 12.20 8.22 14.90

4. Organic Matter (%) 6.30 6.60 8.24 5.40 5.44 8.68 6.10 8.24

5. SO4—2 (mg/kg) 886.7 804.4 224.6 110.5 423.7 547.2 518.5 134.4

6. Chloride (mg/kg) 687.4 506.7 781.0 694.8 496.3 694.8 794.0 723.2

7. Total hardness (mg/kg) 1082.4 1649.4 876.2 972.8 2113.3 2577.2 927.8 2113.3

8. Magnesium (mg/kg) 162.7 275.4 152.7 150.2 200.7 440.7 170.3 225.6

9. Bulk density (g/cm3) 1.20 1.05 1.24 1.37 1.16 1.22 1.32 1.25

10. Calcium (mg/kg) 412.8 516.0 247.6 309.6 516 763.7 227.0 474.7

11. WHC (%) 36.89 47.99 37.80 36.91 36.32 39.31 38.37 32.26

12. Porosity (%) 54.71 60.37 53.20 48.30 56.22 53.96 50.18 52.83

13. Nitrate Nitrogen (as NO3‐ ‐ N) (mg/kg) 294.1 114.5 68.2 144.1 7.65 142.3 80.23 139.7

14. Total Alkalinity (as CaCO3) (mg/kg) 400.0 550.0 200.0 200.0 1800.0 1500.0 500.0 1100.0

15. Grain Size (%)

Gravel 00 00 04 02 00 00 00 00

Coarse sand 00 00 00 01 00 00 03 00

Medium sand 00 00 00 00 00 00 01 00

Fine sand 05 10 12 06 30 26 50 24

Silt + Clay 95 90 84 91 70 74 46 76

TABLE ‐ 3.13 (CONTD.) ___________________________________________________________________________ PHYSICO‐CHEMICALS CHARACTERISTICS OF SOIL (HEAVY METALS) Sr.

No.

Parameter

(mg/kg)

Project

Site (S1)

Panelav (S2) Vanseti

(S3)

Tajpura

(S4)

Gopipura

(S5)

Baska

(S6)

Ujeti

(S7)

Nurpura

(S8)

1. Na 1541 1858 888 1444 2452 1479 1075 976

2. Cu+2 BDL BDL BDL BDL BDL BDL BDL BDL

3. Fe+3 6.23 97.1 48.7 118.6 44.4 29.9 96.0 28.2

4. K 1802 2039 2352 2838 3134 2285 1835 2161

Note: Minimum Detectable Limit: Copper – 0.5 mg/kg

3- 29

3.5.2 SOIL CLASSIFICATIONS

3.5.2.1 METHOD OF PREPARATION

The soil classification map has been prepared by extracting the areas under different soil

categories from the 1:500,000 scale maps prepared by National Bureau of Soil Survey and

Landuse Planning (NBSS & LUP). The project site, towns and village locations have been

added for ease of spatial reference. Locations of towns and villages have been extracted from

CoI maps, SoI topographical maps and confirmed with satellite data.

3.5.2.2 DESCRIPTION OF SOIL CHARACTERISTICS AND AREA UNDER DIFFERENT SOIL TYPES

Table 3.14 provides the soil type and area under different soils within the area of interest.

3.5.2.3 SOIL CHARACTERISTICS MAP

A map depicting the characteristics of major soil categories in the project area is presented

in Figure 3.6. The map also marks the area within 10 km with project site as a centre. Town

and village locations are also depicted to facilitate ease of reference.

TABLE 3.14 ___________________________________________________________________________ SOIL CHARACTERISTICS UNDER PROJECT AREA

Category Area

(Sq. kms) Description Taxonomy1 Taxonomy2 Class

Sub

Class

Category B 43.79

Rock outcrops; associated with

shallow well drained, loamy‐

skeletal soils on moderately steep

sloping basaltic hills and ridges

with severe erosion and moderate

stoniness Rock outcrops

Loamy‐

skeletal,

mixed,

hyperthermic

Lithic

Ustorthents

Soils of west

coast(soils of

Gujarat plain)

Soils of hilly

terrain

Category C 47.68

Moderately deep, well drained,

fine soils on very gently sloping

granitic interfluves with moderate

erosion; associated with deep, well

drained, fine soils with slight

erosion

Fine, mixed,

hyperthermic

Fluventic

Ustochrepts

Fine, mixed,

hyperthermic

Udic

Ustochrepts

Soils of west

coast(soils of

Gujarat plain)

Soils of

interfluves

3- 30

Category D 41.14

Very deep, well drained,

calcareous coarse‐loamy soils on

very gently sloping dissected plain

with very severe erosion;

associated wit very deep, well

drained, calcareous, fine‐loamy

soils with moderate erosion

Coarse‐loamy,

mixed

(calcareous),

hyperthermic

Typic

Ustorthents

Fine‐loamy,

mixed

(calcareouos),

hyperthermic

Fluventic

Ustochrepts

Soils of west

coast(soils of

Gujarat plain)

Soils of

alluvial

plains

Category F 107.87

Deep, moderately well drained

,fine soils on very gently sloping

alluvial plain with slight erosion;

associated with very deep, well

drained, fine‐loamy soils with

moderate erosion

Fine, mixed,

hyperthermic

Udic

Ustochrepts

Fine‐loamy,

mixed,

hyperthermic

Fluventic

Ustochrepts

Soils of west

coast(soils of

Gujarat plain)

Soils of

alluvial

plains

Category G 58.56

Very deep, moderately well

drained, calcareous fine soils on

very gently sloping alluvial plain

with slight erosion; associated with

very deep, moderately well

drained, fine soils with slight

erosion

Fine,

montmorillonit

ic (calcareous),

hyperthermic

Typic

Chromusterts

Fine,

montmorillonit

ic

hyperthermic

Typic

Chromusterts

Soils of west

coast(soils of

Gujarat plain)

Soils of

alluvial

plains

Other 15.89

(Courtesy: Environmental Information Centre, New Delhi)

3- 31

FIGURE‐3.6 SOIL CHARACTERISTICS MAP

3- 32

3.6 GEOLOGICAL DATA

3.6.1 METHOD OF PREPARATION

The geological classification map has been prepared by extracting the areas under different

geological classification from the 1:2 million‐scale maps prepared by Geological Survey of

India (GSI) for the State of Gujarat. The map text has been modified in consultations with the

Department of Geology, University of Delhi. The project site, towns and village locations have

been added for ease of spatial reference. Locations of towns and villages have been extracted

from CoI maps, SoI topographical maps and confirmed with satellite data.

3.6.2 DESCRIPTION OF GEOLOGICAL CLASSIFICATION AND AREA UNDER DIFFERENT

FORMATIONS

Table 3.15 provides the major geological features and area under different formations.

3.6.3 GEOLOGICAL MAP

A map depicting the major geological features in the project area is presented in Figure 3.7.

The map also marks the area within 10 km with project site as a centre. Town and village

locations are also depicted to facilitate ease of reference.

TABLE – 3.15 DESCRIPTION OF GEOLOGICAL CLASSIFICATION AND AREA UNDER DIFFERENT FORMATIONS


Category Area

(sq.km.) Age

Description

▀KPgd = Deccan Traps 53.527

Cretaceous û Palaeogene (65‐60 million years)

Close of the Mesozoic era witnessed a major volcanic activity with the outpouring of lava in parts of Saurashtra, Kachchh, southern Gujarat and eastern parts of Panchmahal and Vadodara districts. The Deccan lavas comprise uniform near horizontal tholeiit

Pt1c = Champaner Group 80.362

Palaeoproterozoic (2500 to 1600 million years)

Outcrops of the Champaner rocks occur in northern Gujarat. The lithology consists of a thick sequence of argillaceous, arenaceous, calcareous and Manganese bearing beds without any volcanic component. Important deposits of manganese occur in Sivrajpur‐

Q = Undifferentiated fluvial/ Aeolian/ coastal sediments 180.068

Holocene in Quaternary period (1 million year to recent)

Some gypsum deposits are found in these Quarternary sediments. High potential for yielding significant quantities of ground water.

3- 33

FIGURE‐3.7

MAJOR GEOLOGICAL FEATURES

3- 34

3.7 LAND USE PATTERN

Land use, in general, reflects the human beings activities on land, whereas the word land

cover indicates the vegetation, agricultural and artificial manmade structures covering the

land surfaces. Identification and periodic surveillance of land uses and vegetation covers, in

the vicinity of any developmental activity is one of the most important components for an

environmental impact assessment, which would help determine the impact of the project

development activity on the land use pattern.

3.7.1 METHOD OF DATA PREPARATION

The land use / land cover has been presented in the form of a map prepared by using IRS P6

LISS‐III and procured from the National Remote Sensing Agency (NRSA), Hyderabad. The

satellite data has been processed using ERDAS Imagine software supported with ground

checks and ground truth verification. Area and distance calculations have been carried out

using GIS software after geo‐referencing the interpreted data with the help of Survey of India

(SoI) topographical maps of the scale 1:50,000.

A map depicting major land use/ land cover classes comprising lands under agriculture, fallow

land, open/degraded vegetation; lands falling under water bodies, scrub and lands under

inhabitations is presented at Figure 3.8. The map also marks the area within 10 km of the

project site as the area of interest. Land use and Land Cover with Towns and Village Locations

A map depicting major land use/ land cover classes along with the village locations in the area

of coverage is presented at Figure 3.9. The land use classification within a distance of ten

kilometers from the project location and the areas falling under the respective classifications

are as per the following:

3- 35

Process Methodology

Procurement of Satellite Imagery

Preparation of Base Map using topographical maps

Data Preparation - Radiometric correction - Geometric correction

Preparation of Signature Confusion Matrix

First Level Classification

Field Verification/Ground Truth

Updated information from field

Second Level Classification

Accuracy Estimation Area EstimationMap Output

Pre field process

Field process

Post field process

3- 36

TABLE – 3.16 ___________________________________________________________________________ AREAS UNDER DIFFERENT LANDUSE


Sr. No. Land use Classification Area (in sq.km.) Percentage Area

1 Water Bodies 4.14 1.32

2 Open/Barren Land 27.38 8.72

3 Agriculture 124.18 39.57

4 Fallow Land 108.78 34.66

5 Degraded Vegetation 14.28 4.55

6 Vegetation Medium Density 9.05 2.88

7 Vegetation High Density 7.08 2.25

8 Scrub 2.49 0.79

9 Marshy Land 2.49 0.79

10 Settlement 9.09 2.90

11 Miscellaneous 4.88 1.55

Total 313.84 100.00

3- 37

FIGURE – 3.8

LANDUSE / LANDCOVER

3- 38

FIGURE – 3.9

LANDUSE / LANDCOVER WITH VILLAGE LOCATIONS

3- 39

3.8 ECOLOGICAL INFORMATION

Introduction

The land use/land cover has been presented in the form of a map prepared by using the IRS‐P

6 LISS‐III, procured from the National Remote Sensing Agency (NRSA), Hyderabad. The


checks and ground truth verification by qualified and experienced professionals. Area and

distance calculations have been carried out using GIS software after geo‐referencing the

interpreted data with the help of SoI topographical maps of 1:50,000 scale. As is evident from

the land use data provided, around 75% of the study area is agriculture and fallow land. The

vegetation comprises of 7 to 10% of the area. The major vegetation of the area is either

medium dense or degraded, however dense vegetation accounts for the presence of

Jambughoda wildlife sanctuary in the project site vicinity.

3.8.1 VEGETATION COVER AND FOREST BOUNDARIES WITHIN PANCH MAHAL DISTRICT

The area in the scope of this study is falling in the Panch Mahal district of Gujarat state. The

comparative account of the forest cover for the Panch Mahal district in the years 2001 and

2011 is given in the below so as to help in assessing the forest status of the area. The

information is obtained from the State of Forest Report published by Forest Survey of India.

The forest cover is classified based on Forest Survey of India into Dense (> 40% crown

density), open (between 10 to 40 % crown density) and Scrubs (shrubby bush of less than 10

% crown density). The vegetation classification criterion used for this study area is given as

follows:

Dense Vegetation is the lands with forest cover with canopy density of equal or more than

40 percent.

Medium Vegetation is the land with forest cover with canopy density of 10 to 40 percent.

Open Vegetation is the land with forest cover with canopy density less than 10 percent.

Scrubs are the lands generally in and around forest areas, having bushes and/or poor tree

growth chiefly of small or stunted trees with a canopy density less than 10 percent.

3- 40

3.8.2 FOREST Bharuch area is characterized by tropical dry deciduous forests. The total forest area of

district is 1449.68 sq.km. That accounts for 0.73 % of the total geographical area of the

district. (Courtesy: Environmental Information Centre, New Delhi)

3.8.3 METHOD OF PREPARATION

The vegetation cover for the area of interest has been prepared by extracting the areas

under four different vegetation classification provided by the Forest Survey of India (FSI)

based on IRS‐ID LISS III data for the past two years for the State of Gujarat. There are five

reserved forest patches falling in the region of interest i.e. within 25 km radius from project

site. The project site and area of interest have been added for ease of spatial reference. The

nearest natural feature is Mahi River 1.7 km west approximately.

3.8.4 AREA UNDER DIFFERENT VEGETATION CLASSIFICATION

Following Table provides the area falling under vegetation type defined as dense forest,

medium dense forest, open forest, scrublands, water bodies and non‐forest areas within the

region of interest (25 km from the project site).

DETAILS OF VEGETATION CLASSIFICATION WITHIN THE STUDY AREA


3.8.5 AREA UNDER FORESTS AND SANCTUARY

There are five reserved forest patches falling in the region of interest i.e. within 25 km

radius from project site. The distances of respective forests are being provided in the table

in the key features of the area in Table‐ 1.3. A map comprising layers of vegetation

classification (ultimately vegetation density of study area), and town as well as village

locations to facilitate ease of reference are provided in Figure‐3.10.

Sr. No. Vegetation Classification Area in Sq. km 1. Water Bodies 15.54 2. Non Vegetation Area 1733.46 3. Scrub 15.68 4. Open Vegetation 100.87 5. Dense Vegetation 93.22 Total 1958.77

3- 41

FIGURE‐3.10

FOREST MAP

3- 42

FIGURE‐3.11

VEGETATION DENSITY MAP WITH VILLAGE LOCATION

3- 43

The major vegetation of the area is either medium dense or degraded, however dense

vegetation accounts for the presence of Jambughoda wildlife sanctuary in the project site

vicinity.

3.8.6 FLORA

Some of the flora found in Bharuch area is listed below:

TABLE – 3.17 ___________________________________________________________________________ LIST OF FLORA

Courtesy: Environmental Information Centre, New Delhi

Botanical Name Common Name

Tectona grandis Sag

Dalbergia latifolia Sisham

Diospyros melanoxylon Tendu/Timru

Anogeissus latifolia Dhav

Aegle marmelos Bili

Mitragayna parviflora Kalam

Lannea coromandelica Modad

Terminalia crenulata Sadad

Acacia catechu Khair

Madhuca indica Mahuda

Lagerstroemea parvijlora

Butea monosperma Palas/Khakharo

Zizyphus sp. Bor

Wrightia tinctoria Dudhalo

3- 44

3.8.7 FAUNA

TABLE – 3.18 ___________________________________________________________________________

LIST OF FAUNA


3.9 SOCIO ‐ ECONOMIC ENVIRONMENT

An assessment of socio ‐ economic environment forms an integral part of an EIA study.

Therefore, baseline information for the same was collected during the study period. The

baseline socio ‐ economic data collected for the study region, before the proposed

expansion is operational, has been identified for the four major indicators viz. demography,

civic amenities, economy and social culture. The baseline status of the above indicators is

compiled in forthcoming sections.

Common Name Zoological Name

Leopard Acinonyx jubatus EX

Jungle cat Felis chaus

Mongoose Herpebles anropunctatus

Crocodile Crocodylus palustris EN

Four horned antelope Tetracerus quadricornis VU

Hyaena Hyaena hyaena

Wolf Canis lupus

Jackal Canis aureus

Barking deer Muntjacus muntjac

Bluebull Boselaphus magocamelus

Wild boar Sus scrofa

Civets Viverricula indica

Porcupine Hystrix indica

Sloth bear Melursus ursinus

Python Python molurus

3- 45

3.9.1 SETTLEMENTS AND DEMOGRAPHIC PATTERN

3.9.1.1 METHOD OF DATA PREPARATION

The land use/land cover has been presented in the form of a map prepared by using the IRS‐P

6 LISS‐III, procured from the National Remote Sensing Agency (NRSA), Hyderabad. The


checks and ground truth verification wherever required. Area and distance calculations have

been carried out using GIS software after geo‐referencing the interpreted data with the help

of SoI topographical maps of 1:50,000 scale.

3.9.1.2 DEMOGRAPHIC DATA WITHIN THE REGION OF INTEREST

The population details (i.e. population distribution and population density) of the Taluka

Halol, District Panchmahal and the study area within 10 km radius and 5 km radius are given

in Table 3.19. And their graphical representations are shown in Figure 3.12.

TABLE – 3.19 DEMOGRAPHIC DATA

Population Data

S. No. Village Name District Name

No. of Household

Total Population

Total Male

Total Female

Population <06 years

Male<06 years

Female<06 years

1 (1) Nava Dhinkva Panch Mahals 615 3546 1914 1632 646 356 290

2 (1) Panch Mahudi Panch Mahals 472 2635 1346 1289 478 233 245

3 (1) Vaghvani Panch Mahals 478 2357 1194 1163 399 204 195

4 Abhetwa Panch Mahals 472 2635 1346 1289 478 233 245

5 Amba Talav Panch Mahals 122 624 337 287 93 50 43

6 Ambavadiya Panch Mahals 157 808 420 388 130 68 62

7 Baliyadev Panch Mahals 78 467 243 224 63 30 33

8 Baska Panch Mahals 482 2684 1409 1275 414 222 192

9 Chhajdivali Panch Mahals 167 1001 517 484 155 74 81

10 Chhatardivav Panch Mahals 141 952 500 452 141 74 67

11 Dholikui Panch Mahals 101 578 292 286 109 56 53

12 Gambhirpura Panch Mahals 213 1063 550 513 147 74 73

13 Ghansar Panch Mahals 486 2407 1285 1122 397 214 183

14 Gokalpura Panch Mahals 96 490 251 239 104 57 47

15 Gopipura Panch Mahals 348 2155 1076 1079 459 214 245

16 Hadabiya Panch Mahals 367 1690 869 821 262 135 127

17 Hadmatiya Panch Mahals 128 616 305 311 101 54 47

18 Intwadi Panch Mahals 282 1486 807 679 213 118 95

19 Jaliya Kuva Panch Mahals 76 459 213 246 86 37 49

20 Jepura Panch Mahals 328 1707 857 850 270 135 135

3- 46

21 Kadachala Panch Mahals 233 1214 605 609 218 99 119

22 Kakara Dungri Panch Mahals 161 841 436 405 124 64 60

23 Kanjari Panch Mahals 1711 8013 4259 3754 1248 687 561

24 Khareda Panch Mahals 98 516 278 238 93 49 44

25 Kota Maida Panch Mahals 111 600 312 288 97 48 49

26 Madar Panch Mahals 336 1764 917 847 290 145 145

27 Mandvi Panch Mahals 96 594 304 290 118 58 60

28 Nathkuva Panch Mahals 270 1671 837 834 327 163 164

29 Navagam Panch Mahals 361 2146 1066 1080 411 196 215

30 Nurpura Panch Mahals 148 744 383 361 123 62 61

31 Panelav Panch Mahals 223 1094 545 549 188 100 88

32 Pratappura (Part) Panch Mahals 478 2357 1194 1163 399 204 195

33 Radhanpur Panch Mahals 87 422 226 196 84 48 36

34 Rameshra Panch Mahals 522 2614 1379 1235 434 237 197

35 Ramjikhantna Muvada Panch Mahals 88 396 205 191 73 35 38

36 Rampura Panch Mahals 64 314 172 142 41 22 19

37 Ranipura Panch Mahals 130 748 379 369 121 59 62

38 Ravaliya Panch Mahals 539 3075 1607 1468 585 302 283

39 Sura Sultanpura Panch Mahals 308 1700 864 836 303 149 154

40 Tajpura Panch Mahals 193 980 503 477 164 82 82

41 Takhatpura Panch Mahals 56 277 138 139 46 20 26

42 Timbi Panch Mahals 117 590 308 282 66 30 36

43 Ujeti Panch Mahals 483 2540 1304 1236 431 220 211

44 Vadatalav Panch Mahals 301 1863 932 931 405 193 212

45 Vankadia Panch Mahals 246 1295 665 630 229 111 118

46 Vanseti Panch Mahals 190 1023 535 488 167 92 75

47 Vav Panch Mahals 266 1489 781 708 262 143 119

48 Vintoj Panch Mahals 325 1692 834 858 275 116 159

49 (1) Bhavnagarpura Vadodara 352 1581 800 781 226 104 122

50 (1) Fulpari Vadodara 61 289 145 144 56 27 29

51 (1) Ranchhodpura Vadodara 217 1078 556 522 237 132 105

52 (1) Shankarpura Vadodara 211 976 510 466 139 73 66

53 (2) Bharvadiyapura Vadodara 694 3364 1708 1656 522 251 271

54 (2) Ishverpura Vadodara 426 2006 1063 943 282 157 125

55 (2) Pratappura Vadodara 459 2168 1099 1069 363 171 192

56 Abhrampura Vadodara 130 602 302 300 78 29 49

57 Adiran Vadodara 457 2199 1104 1095 356 164 192

58 Hansapura Vadodara 211 1203 625 578 205 120 85

59 Karmasiya Kheda Vadodara 652 3273 1683 1590 524 280 244

60 Khandiwada Vadodara 197 970 496 474 167 89 78

61 Mudhela Vadodara 218 1012 525 487 144 70 74

62 Panch Devla Vadodara 140 721 375 346 114 65 49

63 Rajpura Vadodara 428 2150 1100 1050 321 180 141

64 Singaniya Vadodara 27 154 77 77 27 16 11

3- 47

TABLE – 3.20 ___________________________________________________________________________

POPULATION DENSITY

Name Population

(Persons)

Population

Density

(Person / sq.

km.)

Sex ratio

(No. of females per

1000 males)

Within 5 km Radius (2001) 19,388 247 928

Within 5 km Radius (2011) 19,889 255 868

Within 10 km Radius (2001) 70,762 225 946

Within 10 km Radius (2011) 56,016 179 870

Taluka Halol (2001) 1,95,275 407 914

Taluka Halol (2011) 2,37,959 496 927

District Panchmahal (2001) 20,24,883 228 939

District Panchmahal (2011) 23,90,776 269 949

(Courtesy: Census Dept., GOI)

3- 48

Details of Population Density

0

100

200

300

400

500

600

Within 5 km Radius Within 10 km Radius Halol Taluka (2001) Halol Taluka (2011) Panchmahal District(2001)

Panchmahal District(2011)

Locaiton

Pop

ulat

ion

Den

sity

Details of Sex Ratio

820

840

860

880

900

920

940

960

Within 5 km Radius Within 10 km Radius Halol Taluka (2001) Halol Taluka (2011) Panchmahal District(2001)

Panchmahal District(2011)

Location

Sex

Rat

io

FIGURE‐3.12

POPULATION DENSITY

3- 49

3.9.1.3 LITERACY RATE

The literacy rate is a major factor, which influences the socio‐cultural condition of a

particular place. Details of literacy rate in District Panch Mahal, Taluka Halol and within 10

km radius and 5 km radius of project site are given in Table 3.21 while their graphical

representation is shown in Figure 3.13.

TABLE 3.21 ___________________________________________________________________________

LITERACY RATE

Name Male Literacy

(%) Female Literacy

(%) Total Literacy

(%)

Within 5 km Radius 69.48 60.13 65.14

Within 10 km Radius 55.95 44.19 48.73

Taluka Halol (2001) 75.37 46.46 61.58

Taluka Halol (2011) 70.91 52.83 62.21

District Panch Mahals (2001) 76.62 45.43 61.50

District Panch Mahals (2011) 69.93 50.07 60.26


3- 50

TABLE 3.21 (CONTD.) ___________________________________________________________________________

LITERACY RATE

Sr. No. Village Name District Name

Population Schedule

tribe

Male Schedule

tribe

Female Schedule

tribe Population

Literate Male

Literate Female Literate

Population Illiterate

Male Illiterate

Female Illiterate

1 Nava Dhinkva Panch Mahals 121 62 59 2516 1420 1096 1030 440 590

2 Panch Mahudi Panch Mahals 421 265 156 1621 912 709 1014 445 569

3 Vaghvani Panch Mahals 165 87 78 1454 800 654 903 358 545

4 Abhetwa Panch Mahals 174 93 81 1790 1070 720 1145 438 707

5 Amba Talav Panch Mahals 0 0 0 568 302 266 143 64 79

6 Ambavadiya Panch Mahals 183 103 80 517 312 205 381 142 239

7 Baliyadev Panch Mahals 68 35 33 321 195 126 210 69 141

8 Baska Panch Mahals 291 159 132 2996 1708 1288 1182 484 698

9 Chhajdivali Panch Mahals 26 15 11 632 359 273 369 172 197

10 Chhatardivav Panch Mahals 1028 532 496 707 402 305 445 190 255

11 Dholikui Panch Mahals 110 50 60 477 285 192 173 56 117

12 Gambhirpura Panch Mahals 27 14 13 702 463 239 485 161 324

13 Ghansar Panch Mahals 519 276 243 1754 1058 696 949 352 597

14 Gokalpura Panch Mahals 319 158 161 353 229 124 281 98 183

15 Gopipura Panch Mahals 2200 1114 1086 1318 777 541 1232 519 713

16 Hadabiya Panch Mahals 380 196 184 1059 636 423 786 317 469

17 Hadmatiya Panch Mahals 0 0 0 747 453 294 476 173 303

18 Intwadi Panch Mahals 352 171 181 1061 637 424 675 255 420

19 Jaliya Kuva Panch Mahals 283 127 156 292 172 120 226 66 160

20 Jepura Panch Mahals 190 94 96 1164 736 428 747 247 500

21 Kadachala Panch Mahals 273 151 122 816 464 352 441 172 269

22 Kakara Dungri Panch Mahals 425 233 192 516 340 176 345 125 220

23 Kanjari Panch Mahals 1448 767 681 5472 3184 2288 2627 1067 1560

24 Khareda Panch Mahals 97 49 48 278 184 94 287 108 179

25 Kota Maida Panch Mahals 129 71 58 536 303 233 173 70 103

26 Madar Panch Mahals 705 358 347 1271 735 536 813 310 503

27 Mandvi Panch Mahals 265 149 116 341 214 127 296 120 176

28 Nathkuva Panch Mahals 1804 936 868 929 549 380 1113 498 615

29 Navagam Panch Mahals 1565 791 774 1330 812 518 1015 354 661

30 Nurpura Panch Mahals 690 358 332 493 283 210 344 149 195

31 Panelav Panch Mahals 67 36 31 870 505 365 364 131 233

32 Pratappura

(Part) Panch Mahals 348 128 220 1865 982 883

790

292

498

33 Radhanpur Panch Mahals 91 50 41 248 149 99 180 66 114

34 Rameshra Panch Mahals 483 243 240 1780 1037 743 898 323 575

35 Ramjikhantna

Muvada Panch Mahals 133 64 69 193 129 64

272

99

173

36 Rampura Panch Mahals 16 8 8 953 607 346 612 202 410

37 Ranipura Panch Mahals 698 350 348 420 280 140 440 157 283

38 Ravaliya Panch Mahals 1770 917 853 2001 1234 767 1493 576 917

39 Sura Panch Mahals 1445 738 707 849 497 352

3- 51

Sultanpura 896 400 496

40 Tajpura Panch Mahals 411 218 193 713 425 288 508 212 296

41 Takhatpura Panch Mahals 146 77 69 157 102 55 218 94 124

42 Timbi Panch Mahals 239 126 113 337 198 139 304 124 180

43 Ujeti Panch Mahals 548 288 260 1806 1069 737 1162 481 681

44 Vadatalav Panch Mahals 1733 855 878 1072 658 414 1099 425 674

45 Vankadia Panch Mahals 736 366 370 842 501 341 604 206 398

46 Vanseti Panch Mahals 65 39 26 725 443 282 481 172 309

47 Vav Panch Mahals 291 157 134 515 322 193 384 151 233

48 Vintoj Panch Mahals 429 235 194 1192 725 467 722 263 459

49

Bhavnagarpura Vadodara 362 186 176 697 423 274

884

520

364

50 Fulpari Vadodara 111 51 60 225 145 80 176 56 120

51 Ranchhodpura Vadodara

52 Shankarpura Vadodara 240 124 116 517 285 232 234 91 143

53

Bharvadiyapura Vadodara 89 48 41 1985 1097 888

1379

665

714

54 Ishverpura Vadodara 0 0 0 1352 787 565 654 352 302

55 Pratappura Vadodara 302 181 121 1365 799 566 803 299 504

56 Abhrampura Vadodara 101 50 51 422 239 183 205 79 126

57 Adiran Vadodara 237 123 114 1690 960 730 733 276 457

58 Hansapura Vadodara 94 46 48 874 531 343 342 110 232

59 Karmasiya

Kheda Vadodara 752 402 350 2541 1458 1083

1033

391

642

60 Khandiwada Vadodara 231 119 112 733 430 303 300 107 193

61 Mudhela Vadodara 110 59 51 524 304 220 210 74 136

62 Panch Devla Vadodara 189 100 89 679 395 284 188 69 119

63 Rajpura Vadodara 0 0 0 1756 978 778 521 190 331

64 Singaniya Vadodara 34 17 17 247 134 113 55 25 30


3- 52

Literacy Rate

0

10

20

30

40

50

60

70

80

90

Within 5 kmRadius

Within 10 kmRadius

Halol Taluka(2001)

Halol Taluka(2011)

PanchmahalDistrict (2001)

PanchmahalDistrict (2011)

Location

Lit

erac

y R

ate

(%)

Male Literacy(%)

FemaleLiteracy(%)

TotalLiteracy (%)

FIGURE‐3.13

LITERACY DATA

3- 53

3.9.2 OCCUPATIONAL STRUCTURE

In economic development of the region its geographical location, natural resources,

business and employment, industries and manpower play vital role. Table 3.22 provides the

occupational patterns in all villages falling within the area of interest.

TABLE 3.22

OCCUPATIONAL STRUCTURE

Sr. No.

Village Name

District Name

Total Work

Population

Main worker

Population

Main Cultivator Population

Main Agriculture Population

Main Household Population

Main Other

Population

Marginal Worker

Population

Non Worker

Population

1 Nava

Dhinkva Panch Mahals 1855 1072 823 81 0 168 783 1691

2 Panch Mahudi Panch Mahals 352 256 98 67 4 87 96 283

3 Vaghvani Panch Mahals 805 409 14 13 5 377 396 1552 4 Abhetwa Panch Mahals 991 964 408 413 0 143 27 1944 5 Amba Talav Panch Mahals 355 180 129 9 0 42 175 356 6 Ambavadiya Panch Mahals 497 245 133 99 0 13 252 401 7 Baliyadev Panch Mahals 193 193 10 182 0 1 0 338 8 Baska Panch Mahals 1789 1273 217 426 21 609 516 2389 9 Chhajdivali Panch Mahals 584 436 356 59 0 21 148 417

10 Chhatardivav Panch Mahals 259 257 65 154 0 38 2 893 11 Dholikui Panch Mahals 243 241 69 105 0 67 2 407 12 Gambhirpura Panch Mahals 768 322 250 36 0 36 446 419 13 Ghansar Panch Mahals 1346 927 352 251 19 305 419 1357 14 Gokalpura Panch Mahals 210 107 93 5 0 9 103 175 15 Gopipura Panch Mahals 1006 897 293 539 4 71 109 1544 16 Hadabiya Panch Mahals 964 560 228 321 0 11 404 881 17 Hadmatiya Panch Mahals 664 644 333 260 2 49 20 559 18 Intwadi Panch Mahals 737 628 166 337 2 123 109 999 19 Jaliya Kuva Panch Mahals 221 195 67 102 0 26 26 297 20 Jepura Panch Mahals 795 545 226 48 2 269 250 1116 21 Kadachala Panch Mahals 648 427 197 194 1 35 221 609

22 Kakara Dungri Panch Mahals 395 172 161 4 0 7 223 466

23 Kanjari Panch Mahals 3413 2372 695 728 9 940 1041 4686 24 Khareda Panch Mahals 223 212 45 142 0 25 11 342 25 Kota Maida Panch Mahals 309 234 139 64 0 31 75 400 26 Madar Panch Mahals 768 713 426 270 0 17 55 1316 27 Mandvi Panch Mahals 266 125 112 11 0 2 141 371 28 Nathkuva Panch Mahals 1118 373 288 25 3 57 745 924 29 Navagam Panch Mahals 1227 844 462 344 2 36 383 1868 30 Nurpura Panch Mahals 289 289 21 262 0 6 0 548 31 Panelav Panch Mahals 589 378 96 51 0 231 211 645

32 Pratappura

(Part) Panch Mahals 834 809 155 206 3 445 25 1821

3- 54

33 Radhanpur Panch Mahals 197 100 9 57 0 34 97 231 34 Rameshra Panch Mahals 1127 822 370 238 8 206 305 1551

35 Ramjikhantna

Muvada Panch Mahals 175 154 34 119 0 1 21 290 36 Rampura Panch Mahals 177 164 37 118 4 5 13 148 37 Ranipura Panch Mahals 1151 917 593 17 0 307 234 1957 38 Ravaliya Panch Mahals 1934 1124 470 617 2 35 810 1560

39 Sura

Sultanpura Panch Mahals 789 516 376 77 4 59 273 956 40 Tajpura Panch Mahals 594 194 22 140 1 31 400 627 41 Takhatpura Panch Mahals 221 115 59 55 0 1 106 154 42 Timbi Panch Mahals 243 119 75 6 0 38 124 398 43 Ujeti Panch Mahals 1447 918 421 298 1 198 529 1521 44 Vadatalav Panch Mahals 808 799 86 528 1 184 9 1363 45 Vankadia Panch Mahals 500 448 237 144 2 65 52 946 46 Vanseti Panch Mahals 595 567 244 219 12 92 28 611 47 Vav Panch Mahals 442 426 268 62 3 93 16 1130 48 Vintoj Panch Mahals 628 625 340 273 0 12 3 1286

49

Bhavnagarpu

ra Vadodara 742 347 92 84 1 170 395 839 50 Fulpari Vadodara 260 260 216 43 0 1 0 141

51

Ranchhodpur

a Vadodara 888 452 90 267 0 95 436 681 52 Shankarpura Vadodara 299 255 44 116 0 95 44 452

53

Bharvadiyapu

ra Vadodara 1934 1719 529 480 9 701 215 1430 54 Ishverpura Vadodara 826 820 69 346 22 383 6 1180 55 Pratappura Vadodara 813 473 421 30 1 21 340 1091 56 Abhrampura Vadodara 349 244 239 1 0 4 105 278 57 Adiran Vadodara 1309 778 370 211 0 197 531 1114 58 Hansapura Vadodara 756 364 204 45 0 115 392 460

59 Karmasiya

Kheda Vadodara 1953 1087 587 405 1 75 885 1621 60 Khandiwada Vadodara 664 205 117 64 0 24 459 369 61 Mudhela Vadodara 287 279 73 132 0 74 8 447 62 Panch Devla Vadodara 463 369 94 263 0 12 94 404 63 Rajpura Vadodara 1291 599 348 170 1 80 692 986 64 Singaniya Vadodara 147 95 66 20 0 9 52 155

(Courtesy: Census Data, 2011)

3- 55

3.9.3 AMENITIES

Infrastructure resource base of the surveyed villages with reference to education, medical,

water resources, post and telegraph, communication, power supply is presented in Table

3.23. There are 45 villages within study area of 10 km radius of plant site. Significant

observations with respect to availability of amenities in study area are as follows.

All of the villages have primary schools, 4 villages have both primary and secondary

education schools. 14 villages have adult education facility. All of the villages in the impact

zone have community health workers, 11 villages have primary health sub center, 3 villages

have registered private practitioners while 7 villages have family planning center, 2 villages

have primary health center. 3 maternity homes, 5 child welfare centers, 2 nursing home, 1

dispensaries and 1 hospital are also available in the impact zone.

In the study area drinking water facilities are good as tank water and well water is available

almost in all the villages, 23 villages have hand pumps. Tank water is available in 22 villages,

2 villages get water from tube well, 2 villages have tap water, 6 villages have river water, 1

village has other.

Post office facility is available in almost in all villages while 4 villages have post and telegraph

facility. Telephone facility is available in 26 villages.

23 villages are well connected through a network of Pucca road. Almost all villages have

Kaccha approach road. Bus is the main mode of transportation and is available in 39 villages,

4 villages are connected with railways and 2 with Navigable waterway.

All the villages get electricity for all purpose i.e. domestic, agriculture and industrial.

3- 56

TABLE 3.23

DETAILS OF AMMENITIES AVAILABLE IN STUDY AREA

Sr. No.

Village Educational Medical Drinking Water Post & Tele

graph

Communi‐cation

Approah to Village

Nearest Town

Power Supply

1. Intwadi P CHW W, TK, HP ‐(‐5 Kms) BS PR, KR Halol‐8 ED,EAG 2. Kanjari P(8), Tr, H D, RP, CHW, PHC,

FPC, MH W, TK, TW,HP, PO, Phone BS PR, KR Halol‐3 EA

3. Pratappura P(2) CHW W, TK, HP Phone BS, KR Halol‐1 EA 4. Radhanpur P CWC, CHW W, TK, HP ‐(‐5 Kms) BS PR, KR Halol‐1 EA 5. Sura‐sultanpura P ‐(‐5 Kms) W ‐(‐5 Kms) BS PR, KR Halol‐13 ‐‐‐‐‐‐ 6. Jepura P, Ac(2) CHW W,TK PO BS PR, KR Halol‐11 ED, EAG 7. Timbi P CHW, CWC W, TK, HP ‐(‐5 Kms) BS PR, KR Halol‐3 EA 8. Rampura P CHW W ‐(‐5 Kms) ‐(‐5 Kms) PR, KR Halol‐7 EA 9. Mandvi P(2) CWC W, TK, HP ‐(‐5 Kms) ‐(‐5 Kms) KR Halol‐4 EA 10. Vadatalav P(2) PHS,CHW W, TK PO BS PR, KR Halol‐10 EA 11. Chhajdiwali P CHW W, TK, HP ‐(‐5 Kms) ‐(‐5 Kms) PR, KR Halol‐11 ED 12 Abhetwa P CHW, PHS, RP W, TK, HP ‐(‐5 Kms) BS PR, KR Halol‐3 EA 13.. Ranipura P(2) CHW W, TK, TW, HP ‐(‐5 Kms) ‐(‐5 Kms) KR Halol‐6 ED 14. Gopipura P(2) PHS, O W, HP, R ‐(‐5 Kms) BS KR Halol‐4 EA 15. Baska P(2), O PHS, CHW TK, R Phone BS PR Halol‐3 EA 16. Narpura P CHW, CWC W, TK, HP, R ‐(‐5 Kms) ‐(‐5 Kms) KR Halol‐3 EA 17. Kotamaida P CHW W, T, TK, R ‐(‐5 Kms) ‐(‐5 Kms) KR Halol‐4 EA 18. Ambatalav P CHW W, TK, R ‐(‐5 Kms) ‐(‐5 Kms) KR Halol‐13 ED, EAG 19 Ujeti P(2), Ac PHS, CHW W, TK PO BS KR Halol‐8 EA 20. Panelav P, Ac CHW W, TK ‐(‐5 Kms) BS PR, KR Halol‐6 EA 21. Vanseti P, Ac CHW W,TK ‐(‐5 Kms) BS PR, KR Halol‐8 EA 22. Tajpura P CHW W,TK PO BS PR, KR Halol‐11 ED 23. Jaliya kuva P CHW W, HP ‐(10+ Kms) BS, KR Halol‐10 ED 24. Nathkuva P(2) CHW W,HP ‐(‐5 Kms) ‐(‐5 Kms) KR Shivrajpur‐10 ED 25. Vankadia P(2) CHW W, HP ‐(‐5 Kms) BS KR Shivrajpur‐10 ED, EO 26. Navagam P(2) PHS W, TK, HP ‐(‐5 Kms) BS KR Halol‐12 EA 27. Vav P, Ac(3) CHW W, TK, C PO BS KR Halol‐8 EA 28. Ghansar P CHW W, TK PO BS PR, KR Halol‐6 EA 29. Vintoj P, H ‐(‐5 Kms) W, TK, HP PO BS PR, KR Halol‐16 EA 30. Kadachala P(7), Ac(2) PHS, FPC, CHW W, TK, HP ‐(‐5 Kms) BS PR Halol‐16 EA 31. Madar P, Ac CHW W, TK, N PO BS PR, KR Halol‐12 ED, EAG 32. Hadabiya P(4) PHS, FPC, NH W, TK ‐(‐5 Kms) BS KR Halol‐18 EA 33. Ambavadiya P, Ac(2) CHW W, TK, HP ‐(‐5 Kms) BS PR, KR Halol‐17 ED, EAG 34. Gamdhirpura P, Ac PHS, CHW, FPC, W,TK ‐(‐5 Kms) BS KR Shivrajpur‐6 ED,EO 35. Ravaliya P, Ac(2), H CWC, PHS, FPC,

CHW W, TK, HP PO BS PR, KR Halol‐20 ED, EAG

36. Kakara Dungri P, Ac(3) MH, CHW W, TK PO ‐(‐5 Kms) KR Shivrajpur‐6 ED, EO 37. Hadmatia P,Ac(2) ‐(‐5 Kms) W, TK ‐(‐5 Kms) ‐(‐5 Kms) KR Shivrajpur‐8 ED,EO 38. Dholikuj P,Ac(2) ‐(‐5 Kms) W, TK ‐(‐5 Kms) ‐(‐5 Kms) KR Shivrajpur‐8 ED 39. Khareda P, Ac CHW W, HP ‐(‐5 Kms) ‐(‐5 Kms) KR Halol‐19 ED 40. Baliyadev P ‐(‐5 Kms) W,TK, HP, O ‐(‐5 Kms) BS PR, KR Halol‐20 ED, EAG 41. Rameshra P, H MH, PHC, FPC,

NH, RP W, T, TK, C PTO, Phone BS PR, KR Halol‐18 EA

42. Takhatpura P ‐(‐5 Kms) W, TK, HP ‐(‐5 Kms) ‐(‐5 Kms) KR Halol‐11 ED, EAG 43. Ramjikhantna P CHW W, TK, HP, R, C ‐(‐5 Kms) ‐(‐5 Kms) KR Halol‐12 EA

3- 57

muvada 44. Chhatardivav P(2) PHS, FPC, CHW W ‐(‐5 Kms) BS PR, KR Halol‐10 ED, EAG 45. Gokalpura P CHW W, TK ‐(‐5 Kms) ‐(‐5 Kms) KR Halol‐9 ED, EAG


ABBREVIATIONS

1. Education

P‐Primary Elementary School

H‐Matriculation or Secondary

O‐Other Educational Institution

PUC‐Higher Secondary/Intermediate/pre‐University/junior Collage

Ac‐ Adult Literacy Class

Tr‐Training School

2. Medical Facilities

RP‐Registered Private Practitioner

PHS‐Primary Health Sub‐Centre

FPC‐Family Planning Centre

PHC‐Primary Health Centre

D‐ Dispensary

CHW ‐ Community Health Worker/Health Worker

H ‐ Hospital

NH ‐ Nursing Home

MH ‐ Maternity Home

PHC ‐ Public Health Centre

CWC ‐ Child Welfare Centre

TB ‐ T.B Clinic

O – Others

3. Drinking Water

T‐Tap Water

HP‐Hand Pump

TK‐Tank Water

W‐Well Water

R‐River Water

C‐Canal

N ‐ Nallah

S – Spring

TW‐ Tube well Water

L‐ Lake

O‐ Others

3- 58

4. Post & Telegraph

PO‐Post Office

PTO‐Post & Telegraph

Phone‐Telephone Communication

5. Communication

BS‐Bus Station

NW‐Navigable Waterway

6. Approaches to Village

PR‐Pucca Road

KR‐Kuchcha Road

7. Power Supply

EA‐Electricity for all purposes

EAG ‐ Electricity for Agriculture

ED ‐ Electricity for domestic

EO ‐ Electricity for other purpose like Industrial, Commercial etc.

____________________________________________________________________________________________________________

4 - 1

CHAPTER - 4

___________________________________________________________________________

ANTICIPATED ENVIRONMENTAL IMPACTS & MITIGATION MEASURES

4.1 IDENTIFICATION OF IMPACTS

Various sources of pollution with respect to wastewater, the flue gas / process emission,

hazardous waste and noise generation along with their qualitative and quantitative analysis

as well as measures taken to control them are discussed herein with details. The network

method was adopted to identify potential impact, which involves understanding of cause-

condition-effect relationship between an activity and environmental parameters. This

method involves the "road map" type of approach to the identification of second and third

order effect. The basic idea is to account for the project activity and identify the type of

impact that could initially occur followed by the identification of secondary and tertiary

impacts.

Identified potential impacts for the various components of the environment, i.e. air, noise,

water, land and socio-economic, are presented in Figure 4.1. It should be noted that in these

illustrations the lines are to be read as "might have an effect on".

____________________________________________________________________________________________________________

4 - 2

FIGURE – 4.1

IMPACT NETWORK ON AIR ENVIRONMENT

Project

Activity Construction Operation

Phase Phase

Release of Air Release of

Pollutants Heat

Primary Change in Impact on Particulates Climatic

Impacts Air Quality Visibility Deposition on Changes

Water, Land

Aesthetic Impact on Impact on

Impact Agricultural Flora & Fauna

Produce

Secondary Impact on Human

Impacts Health

Tertiary Impact on Impact on

Impacts Economic Output Socio - Cultural

Environment

____________________________________________________________________________________________________________

4 - 3

FIGURE – 4.1 CONTD.

IMPACT NETWORK ON NOISE ENVIRONMENT

Project

Activity Construction Operational

Phase Phase

Noise Emission

Primary

Impacts Change in

Ambient

Noise Level

Secondary Health Risks Impact on Work Migration of Birds,

Impacts Output and Reptiles & Population

Efficiency


Impacts Economic Socio-cultural

Output Environment

____________________________________________________________________________________________________________

4 - 4


IMPACT NETWORK ON WATER ENVIRONMENT

Project

Construction Phase Operational Phase

Activity Change in Surface Releases of

Morphology Wastewater

Impact on Runoff/

Seepage

Primary Impact on Impact on Environmental

Impacts Hydraulics of Water Quality Health and

Water Courses Aesthetic Risk

Secondary Impact on Impact on Cost of Water Impact on

Impacts Hydraulic of Aquatic Life Treatment Amenity /

Water Cources Recreation

Impact on Economic Output Impact on Socio-Cultural

Impacts Environment

____________________________________________________________________________________________________________

4 - 5


IMPACT NETWORK ON GROUND WATER ENVIRONMENT

Project

Cnstruction Operational

Phase Phase

Activity Distrubance Release of

of Soil Waste-water

on Land

Primary Change in Groundwater Change in Structure Addition / Removal

Impacts Regime : Soil Moisture / of Soil : Ground of Substances or

water Level / Flow Level Heat to / form

Pattern / Salt Water the Soil

Instruction

Secondary Impact on Soil Biota Impact on Flora Impact on

Impacts and Fauna Landscape

Impact on Agriclutural Impact on Livestock

Production


Impacts Economic Socio - Cultural

Out Put Environment

____________________________________________________________________________________________________________

4 - 6


IMPACT NETWORK ON LAND ENVIRONMENT

Project

Activity Construction Operational

Phase Phase

Primary Disturbance Disposal of

Impacts of land Wastewater

& Sludge on Land

Change in soil Change in Ground Toxic Substances

Texture & Permeability Water Regime / Salt on Land, Particulate

Water Intrusion Deposition on Land

Secondary Impact on Soil Salinity Impact on

Impacts Landscape Flora & Fauna


Impacts Agricultural Produce Live Stock

Impact on Impact on Socio-

Economic Output Cultural Environment

____________________________________________________________________________________________________________

4 - 7


IMPACT NETWORK ON SOCIO-ECONOMIC & CULTURAL ENVIRONMENT

Project

Activity Operational Phase Construction Phase

Primary Economic Input Economic Output Demand for Wark Force

Impacts Capital/C&M Cost Product Cost

Net Income

Output

Secondary Change in Development Better Air, Water Empolyment Demand for Demand for Aesthetic

Impacts Economic Base of Ancillary Product Land, Noise Opportunity Communication Infrastructural Risk

of The Region Industries Avaliability Pollution Facilities Facilities

Saving of Foreign

Exchange Effect On Effect On Effect On Effect on

Human Health Agriculture & Visual Buildings

Fisheries Environment Materials

Mounments

Tertiary Effect On Water Supply, Effect On Educational Effect On Human, Nature &

Impacts Sewerage & Soild Waste Medical, Transport Recreational Facilities

Management Facilities Facilities

____________________________________________________________________________________________________________

4 - 8

4.2 PREDICTIONS AND EVALUATION OF IMPACTS

An impact can be defined as any change in physical, chemical, biological, cultural and/or

socioeconomic environment that can be attributed to activities related to alternatives under

study for meeting the project needs. Impact methodology provides an organized approach

for prediction and assessing these impacts. Scientific techniques and methodologies based

on mathematical modeling are available for studying impacts of various project activities on

environmental parameters.

The nature of the impacts due to said project activities are discussed here in detail. Each

parameters identified in the proceeding chapter, is singularly considered for the anticipated

impact due to various activities listed. The impact is quantified using numerical scores 0, 1,

2, 3, 4 and 5 in increasing order of activity. In order to assess the impact accurately, each

parameter is discussed in detail covering the following:

1) Project activities likely to generate impact

2) Quantification and prediction of impact

4.2.1 WATER ENVIRONMENT

Water Consumption & Waste Water Generation is given in Table 2.2. Details of ETP are

discussed in Topic 2.4.3.1 of Chapter 2. Hence, overall there won’t be any significant adverse

impact due to proposed expansion activity on the water environment. Ground water and

soil will not get contaminated, as M/s. Alembic Pharmaceuticals Limited (Unit-I) is not going

to discharge any effluent on land. With the above, it can be said that there will be no

significant adverse impact on surface and ground water or soil quality.

____________________________________________________________________________________________________________

4 - 9

4.2.2 AIR ENVIRONMENT

The dispersion of pollutants in the atmosphere is a function of several meteorological

parameters viz. temperature, wind speed and direction, mixing depths, inversion level, etc.

A number of models have been developed for the prediction of pollutant concentration at

any point from an emitting source. The Industrial Source Complex – Short Term (ISCST3)

dispersion model is a steady-state Gaussian plume model. It is most widely accepted for its

interpretability. It gives reasonably correct values because this obeys the equation of

continuity and it also takes care of diffusion, which is a random process. For the present

study, this model is used for the prediction of maximum ground level concentration (GLC).

The proposed air emissions at M/s. Alembic Pharmaceuticals Limited (Unit-I) are SPM, SO2,

NOx, HCl. The site specific and monitored details considered for input data for the software

“ISC-AERMOD View” by Lakes Environmental, Canada for prediction of impact on air

environment are given in Table 4.1. The site-specific hourly meteorological data measured

at site is given in Table 3.5. In order to conduct a refined air dispersion modeling using

ISCST3 and ISC-PRIME short-term air quality dispersion models, the site specific hourly

meteorological data measured at site is pre-processed using the U.S. EPA PCRAMMET and

U.S. EPA AERMET programs. Before starting air dispersion modeling with ISC-AERMOD View,

a building downwash analysis using BPIP View was done. BPIP View is a graphical user

interface designed to speed up the work involved in setting up input data for the U.S. EPA

Building Profile Input Program (BPIP) and Building Profile Input Program – Plume Rise Model

Enhancements (BPIP-PRIME).

The air pollution caused by the gaseous emissions from a single or small group of stacks is a

local phenomenon. Its impacts will occur at a distance ranging from within the immediate

vicinity of the stack to several kilometers away from the stack. Maximum ground level

concentration will occur within this range. All plumes at more downwind distances from the

source by stack emission become so diluted by diffusion in the ambient atmosphere, that

concentrations of pollutants become negligible. The maximum ground level concentration

for different parameters is given in Table 4.2. Equal concentration contour plots for SPM,

SO2, NOx, HCl, Cl2, HF, CO, NH3 are given in Figure 4.2. Adequate measures shall be taken to

____________________________________________________________________________________________________________

4 - 10

minimize air pollution by providing air pollution control equipment. Flue gases are

discharged from stacks at adequate height (as per GPCB norms).

TABLE – 4.1

DETAILS OF EMISSION FROM STACK & VENTS (EXISTING)

(* Permissible Limits)

STACK & VENTS ATTACHED TO:

1. Agro based Boiler 5 TPH

2. Boiler 1 & 2 (2 TPH)

3. D.G.Set (750 KVA)

4. Incinerator

5. Reaction Vessels Pilot Plant

6. Reaction Vessels No-1 in Plant-1 (Replaced)

SOURCE OF EMISSION SR.

NO.

OPERATING

PARAMETER

UNIT

1 2 3 4 5 6

1. Stack height Meter 35 30 12 38 12 12

2. Diameter Meter 0.5 0.5 0.3 0.6 0.2 0.2

3. Flue Gas

Temperature

0K 386 369 450 341 303 303

4. Air Pollution

Control

Equipment

- Bag

Filter

Bag

Filter

- Quencher

& Alkali

Scrubber

Alkali

Scrubber

Chilled

Water

Circulation

5. Flue Gas

Velocity

m/s 5.56 4.59 6.28 4.84 6.6 6.6

6. Emission

concentration

SPM

SO2

NOx

HCl

HF

CO

Cl2

NH3

mg/Nm3

mg/Nm3

mg/Nm3

mg/Nm3

mg/Nm3

mg/Nm3

mg/Nm3

mg/Nm3

36.8

16.2

14.5

---

---

---

---

---

35.2

13.7

11.4

---

---

---

---

---

16.4

8.7

6.7

---

---

---

---

---

38

20.2

38.1

4.76

4*

100*

---

---

---

---

---

4.24

---

---

2.97

---

---

---

---

---

---

---

---

7.26

____________________________________________________________________________________________________________

4 - 11

TABLE – 4.1 CONTD.

DETAILS OF EMISSION FROM STACK & VENTS (EXISTING)



7. Reaction Vessels No-2 in Plant-1 (Replaced)

8. Reaction Vessels in Plant-2



11. Reaction Vessels No-2 in Plant-2


NO.

OPERATING

PARAMETER

UNIT

7 8 9 10 11

1. Stack height Meter 12 12 12 12 12

2. Diameter Meter 0.2 0.2 0.2 0.2 0.2

3. Flue Gas

Temperature

0K 303 303 303 303 303

4. Air Pollution

Control

Equipment

- Alkali

Scrubber

Alkali

Scrubber

Alkali

Scrubber

Alkali

Scrubber

Chilled

Water

Circulation

5. Flue Gas

Velocity

m/s 6.6 6.6 6.6 6.6 6.6

6. Emission

concentration

HCl

Cl2

NH3

mg/Nm3

mg/Nm3

mg/Nm3

4.26

3.04

---

5.28

2.92

---

6.98

3.46

---

4.01

2.92

---

---

---

175*

____________________________________________________________________________________________________________

4 - 12

TABLE – 4.1 CONTD.

DETAILS OF EMISSION FROM STACK & VENTS (PROPOSED)



12. Water Tube FBC Boiler 10 TPH

13. Thermic Fluid Heater



16. Reaction Vessels No-1 in Ware-House


NO.

OPERATING

PARAMETER

UNIT

12 13 14 15 16

1. Stack height Meter 35 12 12 12 12

2. Diameter Meter 0.5 0.3 0.2 0.2 0.2

3. Flue Gas

Temperature

0K 418 323 303 303 303

4. Air Pollution

Control

Equipment

- ESP(Dry

Horizontal

type with

3 field)

- Chilled

Water

Circulation

Alkali

Scrubber

Alkali

Scrubber

5. Flue Gas

Velocity

m/s 4.5 5.3 6.6 6.6 6.6

6. Emission

concentration

SPM

SO2

NOx

HCl

Cl2

NH3

mg/Nm3

mg/Nm3

mg/Nm3

mg/Nm3

mg/Nm3

mg/Nm3

150*

262*

94*

---

---

---

150*

262*

94*

---

---

---

---

---

---

---

---

175*

---

---

---

20*

9*

---

---

---

---

20*

9*

---

____________________________________________________________________________________________________________

4 - 13

FIGURE - 4.2

ISOPLETHS FOR PM (EXISTING)

____________________________________________________________________________________________________________

4 - 14

FIGURE - 4.2 (CONTD.)

ISOPLETHS FOR SO2 (EXISTING)

____________________________________________________________________________________________________________

4 - 15


ISOPLETHS FOR NOx (EXISTING)

____________________________________________________________________________________________________________

4 - 16


ISOPLETHS FOR HCl (EXISTING)

____________________________________________________________________________________________________________

4 - 17


ISOPLETHS FOR Cl2 (EXISTING)

____________________________________________________________________________________________________________

4 - 18


ISOPLETHS FOR HF (EXISTING)

____________________________________________________________________________________________________________

4 - 19


ISOPLETHS FOR CO (EXISTING)

____________________________________________________________________________________________________________

4 - 20


ISOPLETHS FOR NH3 (EXISTING)

____________________________________________________________________________________________________________

4 - 21

TABLE -4.2

SUMMARY OF ISCST3 MODEL OUTPUT FOR PM, SO2, NOx & HCl (EXISTING)

As manufacturing activities have not yet started, the predictions were made using CPCB

permissible limit as these concentrations will in no case be exceeded. Ground level

concentrations calculated for proposed expansion activities are superimposed on existing

ambient air quality monitoring results and combined values (Table 4.4) are found within

permissible National Ambient Air Quality Standards.

CONCENTRATION (µµµµg/m3) SR.

NO

LOCATIONS CO-ORDINATES

(X, Y) PM NOx SO2 HCl

1. Project-site (A1) (0,0) 0.00 0.00 0.00 0.00

2. Panelav (A2) (1481, -370) 0.21 0.39 0.45 0.11

3. Vanseti (A3) (1296, -1111) 0.18 0.33 0.38 0.09

4. Tajpura (A4) (741, -1296) 0.14 0.26 0.30 0.08

5. Gopipura (A5) (185, 926) 0.01 0.03 0.03 0.01

6. Baska (A6) (-1852, 926) 0.02 0.02 0.03 0.01

7. Ujeti (A7) (2037, -1111) 0.13 0.24 0.28 0.06

8. Nurpura (A8) (-556, 1852) 0.01 0.02 0.02 0.01

MAXIMUM CONCENTRATION (µµµµg/m3) SR.

NO.

X, Y

CO-ORDINATES PM NOx SO2 HCl

1. (1000, 0) 0.242 - - -

2. (1000, 0) - 0.45218 - -

3. (1000, 0) - - 0.51484 -

4. (1000, 0) - - - 0.15587

____________________________________________________________________________________________________________

4 - 22

TABLE -4.2 CONTD.

SUMMARY OF ISCST3 MODEL OUTPUT FOR Cl2, HF, CO & NH3 (EXISTING)


NO


(X, Y) Cl2 HF CO NH3

1. Project-site (A1) (0,0) 0.00 0.00 0.00 0.00

2. Panelav (A2) (1481, -370) 0.03 0.00 0.07 0.27

3. Vanseti (A3) (1296, -1111) 0.03 0.00 0.06 0.22

4. Tajpura (A4) (741, -1296) 0.03 0.00 0.05 0.20

5. Gopipura (A5) (185, 926) 0.00 0.00 0.01 0.02

6. Baska (A6) (-1852, 926) 0.00 0.00 0.00 0.03

7. Ujeti (A7) (2037, -1111) 0.02 0.00 0.04 0.14

8. Nurpura (A8) (-556, 1852) 0.00 0.00 0.00 0.01


NO.

X, Y

CO-ORDINATES Cl2 HF CO NH3

1. (1000, 0) 0.05164 - - -

2. (1000, 0) - 0.00326 - -

3. (1000, 0) - - 0.08152 -

4. (1000, 0) - - - 0.41311

____________________________________________________________________________________________________________

4 - 23

FIGURE - 4.2

ISOPLETHS FOR PM (PROPOSED)

____________________________________________________________________________________________________________

4 - 24


ISOPLETHS FOR SO2 (PROPOSED)

____________________________________________________________________________________________________________

4 - 25


ISOPLETHS FOR NOx (PROPOSED)

____________________________________________________________________________________________________________

4 - 26


ISOPLETHS FOR HCl (PROPOSED)

____________________________________________________________________________________________________________

4 - 27


ISOPLETHS FOR Cl2 (PROPOSED)

____________________________________________________________________________________________________________

4 - 28


ISOPLETHS FOR NH3 (PROPOSED)

____________________________________________________________________________________________________________

4 - 29

TABLE -4.2

SUMMARY OF ISCST3 MODEL OUTPUT FOR PM, SO2, NOx, HCl, Cl2 & NH3 (PROPOSED)

As manufacturing activities have not yet started, the predictions were made using CPCB

permissible limit as these concentrations will in no case be exceeded. Ground level

concentrations calculated for proposed expansion activities are superimposed on existing

ambient air quality monitoring results and combined values (Table 4.4) are found within

permissible National Ambient Air Quality Standards.


NO


(X, Y) PM NOx SO2 HCl Cl2 NH3

1. Project-site (A1) (0,0) 0.00 0.00 0.00 0.00 0.00 0.00

2. Panelav (A2) (1481, -370) 0.22 0.14 0.39 0.10 0.01 0.13

3. Vanseti (A3) (1296, -1111) 0.18 0.12 0.32 0.09 0.01 0.11

4. Tajpura (A4) (741, -1296) 0.16 0.10 0.27 0.08 0.01 0.10

5. Gopipura (A5) (185, 926) 0.01 0.01 0.02 0.01 0.00 0.01

6. Baska (A6) (-1852, 926) 0.02 0.01 0.03 0.01 0.00 0.01

7. Ujeti (A7) (2037, -1111) 0.13 0.08 0.22 0.05 0.01 0.07

8. Nurpura (A8) (-556, 1852) 0.01 0.01 0.02 0.00 0.00 0.01


NO.

X, Y

CO-ORDINATES PM NOx SO2 HCl Cl2 NH3

1. (1000, 0) 0.29274 - - - - -

2. (1000, 0) - 0.18482 - - - -

3. (1000, 0) - - 0.51211 - - -

4. (1000, 0) - - - 0.16066 - -

5. (1000, 0) - - - - 0.02066 -

6. (1000, 0) - - - - - 0.20656

____________________________________________________________________________________________________________

4 - 30

TABLE 4.3

___________________________________________________________________________

PREDICTED AMBIENT AIR QUALITY FOR PM, SO2, NOx, HCl, Cl2 & NH3 Unit: µµµµg/m3

SPM SO2 NOx HCl Cl2 NH3 SR.

NO.

SAMPLING

LOCATION AVERAGE

1. Project-site (A1) 120.54 12.72 14.12 BDL BDL 3.41

2. Panelav (A2) 105.88 12.37 12.60 BDL BDL 2.65

3. Vanseti (A3) 113.69 13.41 13.97 BDL BDL 4.63

4. Tajpura (A4) 124.45 13.16 14.18 BDL BDL 4.07

5. Gopipura (A5) 131.96 14.27 15.38 BDL BDL 4.65

6. Baska (A6) 109.10 10.52 11.53 BDL BDL 2.53

7. Ujeti (A7) 118.93 11.90 13.55 BDL BDL 4.00

8. Nurpura (A8) 110.51 10.96 12.79 BDL BDL 2.12

BDL: Below Detectable Limit

4.2.3 NOISE ENVIRONMENT

Noise level around the plant site was measured. These values (Table-3.10) represent status

of Noise levels. Adequate noise control measures such as mufflers, silencers at the air

inlet/outlet, anti vibration pad for equipment with high vibration, earmuff and earplugs to

the operators, etc. are provided. Housing / casing is provided for all noise generating

machines. The noise level within plant will be less than 75 dB(A).

4.2.4 HAZARDOUS WASTE DETAILS

Hazardous wastes generation is given in Table 2.3.

4.2.5 INFRASTRUCTURE AND SERVICES

The plant is located in a well-developed industrial area, which has all essential facilities such

as water, power, fuel, post, telecommunication, bank, etc. M/s. Alembic Pharmaceuticals

Limited (Unit-I) shall get water from own bore well. The power requirement of proposed

expansion scenario will be 54225 KWH. Company shall purchase power from MGVCL. DG Set

____________________________________________________________________________________________________________

4 - 31

of 750 KVA (1 No. Existing & 1 No. Additional Proposed) will be provided for emergency

power backup. The transportation of raw materials and finished products shall be by road.

As stated earlier, the site is near to National Highway no. 8. As a result of proposed

expansion project there will be a marginal increase in transportation activity as compared to

present total traffic upto plant premises. As a result of development of industrial estate, the

neighboring areas have developed for commercial use. The infrastructure services e.g.

roads, state transport, post and telegraph, communication, education and medical facilities,

housing, etc. have improved in the surrounding areas in recent years.

4.2.6 ENVIRONMENTAL HAZARD

Raw material such as different chemicals etc. shall be transported by road and shall be

stored in the plant premises. On site emergency plan shall be prepared for storage and

handling of hazardous chemicals and shall also be submitted to relevant authorities. This

report will be prepared with the consideration of hazards associated with the chemicals and

care should be taken for all aspects of environmental hazards. The project proponent shall

consider all the safety aspects in planning, designing and operation of the plant as per

standard practices. Hence, no adverse impact on this account is anticipated.

4.2.7 HOUSING

Enough number of dwellings is available in nearby towns and villages for accommodating

extra workforce. On neighboring towns or villages, the impact on this account is minimal.

4.2.8 ECOLOGY

The impact due to operation of the project and its activities on the ecological parameters

like natural vegetation, cropping pattern, fisheries and aquatic life, forests and species

diversity could be summarized as below.

4.2.8.1 NATURAL VEGETATION

The industry will develop a green belt on the surrounding periphery. Since the effluents and

emissions generated from the project activities shall be treated and disposed as per the

____________________________________________________________________________________________________________

4 - 32

EMP provisions, adverse impact over any of the ecological components of the environment

is reduced to minimum.

4.2.8.2 CROPS

Since, the project shall be on a non-agricultural land, it shall not alter the crop production of

the area. Further, the necessary environmental protection measures have been planned

under EMP e.g. air pollution control systems shall be designed to take care of even

emergency releases of the gaseous pollutants like SPM, SO2, NOx, HCl and regular

environmental surveillance shall be done, so as not to have any short-term or cumulative

effect on the crops and the natural vegetation of the area.

4.2.8.3 FISHERIES AND AQUATIC LIFE

Since the effluents and emissions generated from the project activities shall be treated and

disposed as per the EMP provisions, proposed expansion project shall not envisaged any

adverse effect on fisheries and aquatic life.

4.2.8.4 AESTHETIC ENVIRONMENT

The proposed expansion activities and further plantation will enhance the aesthetic

environment.

4.2.8.5 DEMOGRAPHY, ECONOMICS, SOCIOLOGY AND HUMAN SETTLEMENT

M/s. Alembic Pharmaceuticals Limited (Unit-I) will give employment to about 602

employees (Existing: 567 + Additional Proposed: 35) (Including Contract workers). In

addition to direct employment, indirect employment shall generate ancillary business to

some extent for the local population. There is a positive effect due to improved

communication and health services, which have lead to economic prosperity, better

educational opportunities and access to better health and family welfare facilities. There has

been a beneficial effect on human settlement due to employment opportunities from

various industries in region in addition to employment generated by M/s. Alembic

Pharmaceuticals Limited (Unit-I) after proposed expansion project more direct and indirect

employment shall be generated.

____________________________________________________________________________________________________________

4 - 33

Local quality of life has improved. This factor combined with all other mitigation measures,

like proper treatment and disposal of hazardous waste; liquid effluent and gaseous

emission, has minimized the adverse impact on ecology and has a beneficial impact on

human settlement and employment opportunities. There has been a beneficial impact on

the local socio-economic environment. There shall be no displacement of any population in

plant area. Any major activity that may lead to resettlement of the people is considered as

permanent impact. Hence, there is no permanent impact on this account. The increasing

industrial activity will boost the commercial and economical status of the locality up to some

extent.

Socio-Economic Environment

Environmental Impact Assessment is a study or an estimate of the probable positive or

negative impact a proposed project or expansion activity of an existing project could have

on the environment, consisting of natural, social and economic aspects. An assessment of

socio-economic environment forms an integral part of an EIA study. Therefore, base-line

information for the same was collected during the study period. The base-line S.E. data

collected for the study region has been identified in four major indicators namely-

Demography, civic amenities, Economy and social culture.

Employment:

During construction phase of the company, skilled and un-skilled manpower will be required

and their requirement will be met with from the local community. M/s. Alembic

Pharmaceuticals Limited (Unit-I) will give employment to 602 employees (Existing: 567 +

Additional Proposed: 35) (Including Contract workers). With the employment opportunities,

local people’s income will increase and thereby, their economic status will boost up.

Further, secondary jobs shall also increase in the local area to provide day-to-day

needs/services to the working men. Demand for essential daily utilities in the market will

also temporarily increase to some extent.

____________________________________________________________________________________________________________

4 - 34

Public Health:

During construction period the workers will be provided wills safe water supply, low-cost

sanitation facilities, first Aid Treatment, necessary personal protective equipment etc., to

prevent an increase in diseases related to personal hygiene. With some other industrial

units coming up in the surrounding area, Govt. dispensary, medical check-up, medicines,

services of nurses & doctors etc. are likely to be increased with a view to taking care of

general health of the local community.

Education:

Presently, every village has a primary school upto VII std. and for higher standard education,

the students, both boys and girls, have to go to Halol. With increase in population due to

industrial growth, the surrounding villages may start higher standards upto X and XII. Not

only male students but female students can also take advantage of the some and thereby,

percentage of literate population in the local area may increase.

Transport:

With increased employment opportunities and higher economic status of the local

community and with an increase in market conditions, transport facilities by way of buses,

two-wheeler & four-wheeler vehicles will develop in future. Thus, overall development of

the local community and their health is likely to become a matter of fact with the co-

operation and support of industrial organizations of the local area. To sum up, it could be

said that there will be a positive effect due to improved communication and health services,

which would lead to economic prosperity, better educational opportunities and access to

better health and family welfare facilities. There will be a beneficial effect on human

settlement due to employment opportunities from various industrial establishments in local

area in addition to employment generated by M/s. Alembic Pharmaceuticals Limited (Unit-

I). There is likely to be a beneficial impact on the local Socio-Economic environment. There

shall be no displacement of any population in the plant area. The increasing industrial

activity will boost up the commercial and economical status of the locality to some extent.

1. This project is on non-agricultural land and therefore, it is not likely to alter the crop

production.

____________________________________________________________________________________________________________

4 - 35

2. The manufacturing unit has adopted comprehensive environmental plan covering

several environment protection measures, to reduce the environmental pollution

resulting from the project.

To control the emission from process and utility stacks, the company would regularly

examine, inspect and test its emission to make sure that the emission is below the

permissible limit. With this, the status of sanitation and community health of the area would

not change.

4.2.8.6 FOREST, NATIONAL PARKS / SANCTUARIES

The details of flora / fauna species and the wildlife habitat in the area covering 10 km radius

have been collected to determine the existence of rare and / or endangered species. There

is Gutal Reserve Forest located at 8.22 km south and other Reserve Forest and Jambughoda

Wildlife Sanctuary is located in Halol and Jambughoda Taluka of Panchmahals district and

Sankheda Taluka of Vadodara district at 29 km from of the plant. There was no acquisition

of forest land or parks for the plant. There shall be no impact on the same.

4.2.8.7 PLACES OF ARCHAEOLOGICAL/HISTORICAL/RELIGIOUS/TOURIST INTEREST

Pavagadh hill is located at about 5 km distance from plant site. Pavagadh hill is a famous

place for pilgrims and tourist. At the top of hill, there is a temple of Kalika Mata. The old

temple on the hill is monuments of archaeological interest. Tourism Corporation of state has

considered this place as eligible centre for growth of tourism. "Champaner", world heritage

place is located about 8 km aerial distance from the project site but "Champaner" is located

in NE direction of "Pavagadh" mountain while the project is located in SW of "Pavagadh"

mountain.

____________________________________________________________________________________________________________

4 - 36

4.3 MATRIX REPRESENTATION

The parameters discussed are presented in the form of a matrix in Table 4.4. There is no

requirement of construction phase and the industry is in operation for existing products.

The impact matrix relating the parameters to the activities during operation phase and

construction phase is presented in Table 4.5. The quantification of impact is done using

numerical scores 0 to 5 as per the following criteria.

Score Severity criteria

0 No impact

1 No damage

2 Slight/ Short-term effect

3 Occasional reversible effect

4 Irreversible/ Long-term effect

5 Permanent damage

The scores for various parameters and activities are presented in Table 4.6.

4.3.1 CUMULATIVE IMPACT CHART

The total negative impact of various activities on any one parameter is represented as a

cumulative score and the cumulative scores of various parameters are given in the form of a

cumulative impact chart presented in Table 4.7. Any particular parameter having an

individual score greater than 5 or cumulative score of 20 implies serious effects due to the

project and calls for suitable mitigation measures. It is evident from the matrices that the

resultant impact is beneficial to the local population and due to export (and import

substitution) the resultant impact is beneficial to our country.

____________________________________________________________________________________________________________

4 - 37

TABLE - 4.4

___________________________________________________________________________

IMPACT IDENTIFICATION MATRIX (CONSTRUCTION PHASE)

ACTIVITIES

DURING

CONSTRUCTI

ON PHASE

Air

Qualit

y

Noise

&

Odour

Water

Quality

Land

Quality

Infrast

ructur

e

Service

s

Env.

Hazard

s

Terrestrial

Ecology

Land use

Socio-

Econo

mic

Status

Aquatic

Ecology

Water

Requirement

× x x × × ×

Material

Storage/

Transport

× × × × × × × × x ×

Material

Handling

× × × × × × ×

Utilities × × × ×

Effluent

Discharge

× x × × × x

Gaseous

Emissions

× × x × x x x

Fugitive

Emissions

× × x × x x x

Solid Waste

Disposal

× × × × x × ×

Spills & Leaks × × × × × ×

Shutdown/

Startup

×

Equipment

Failures

× x

Transport of

Workers

× × × ×

Movement of

Vehicles

× × x × ×

Medical &

Other Needs

× ×

____________________________________________________________________________________________________________

4 - 38

TABLE – 4.4 (CONTD.)

___________________________________________________________________________

IMPACT IDENTIFICATION MATRIX (OPERATION PHASE)

ACTIVITIES

DURING

OPERATION

PHASE

Air

Quality

Noise

&

Odour

Water

Qualit

y

Land

Quality

Infrastr

ucture

Services Env.

Hazards

Terrestrial

Ecology

Land use

Socio-

Economic

Status

Aquatic

Ecology

Water

Requirement

x X X

Raw material

Storage/

Transport

X X X X X

Raw Material

Handling

X X X X

Utilities X X X X

Effluent

Discharge

X X X X X X

Gaseous

Emissions

X X X

Fugitive

Emissions

X X X X

Solid Waste

Disposal

X X X X X X

Product

Storage/

Handling

X X X

Spills & Leaks X X X X X X X X

Shutdown/

Startup

X X X X

Equipment

Failures

X X X

Plant

Operations

X X X X X X X X

Transport of

Workers

X X X

Movement of

Vehicles

X X X

Medical &

Other Needs

X X X

____________________________________________________________________________________________________________

4 - 39

TABLE - 4.5

__________________________________________________________________________

CONSTRUCTION & OPERATION STAGE POTENTIAL IMPACTS & MITIGATIVE MEASURES

ENVIRONMENTA

L COMPONENTS

POTENTIAL IMPACTS SOURCES OF IMPACT MITIGATIVE MEASURE REMARKS

Water Quality Deterioration of water

quality

Construction activity &

abstraction of water for

construction

requirement and

sanitation in housing

for workers.

Discharge of process

effluents, sewage and

utility wastewater

Proper management of

surface water run off

shall be made

Effluent treatment

plant (ETP)

Zero Discharge Unit

Discharge standards

specified by authorities

are being met

Minor adverse impact

Air Quality Increase in SO2, NOX,

SPM & HCl & Cl2

concentrations in

ambient air

Process emissions,

Fugitive emissions &

Utility stack emissions

Control equipment for

fugitive emissions

Adequate stack heights

& APCE

No remarkable increase

in GLCs.

NAAQ Standards are

met

Minor adverse impacts

on ambient air quality

Socio-Economic Overall growth &

development of area,

increased employment,

improvement in

infrastructure and

growth of downstream

industries

Project activities General area planning

in advance by GIDC and

classified as notified

industrial estate by

GIDC

Beneficial change

Terrestrial

Ecology

Minor loss of habitat-

flora & fauna, loss of

agricultural land

Project activities Green belt Proper

management of solid

waste

No impact

Noise Increased noise level Project operation Noise abatement at

generation point &

green belt before

receptor

Marginal impact

Infrastructure &

Services

Improved

communication,

transport, housing,

educational & medical

facilities

Project Development has been

gradual

Beneficial impact

Environmental

Hazards

Risk to environment &

neighboring population

Handling and storage of

chemicals, solvents &

fuels

On site & off site

Disaster management

plan &

Safe practices

Insignificant adverse

impact

____________________________________________________________________________________________________________

4 - 40

TABLE - 4.6

___________________________________________________________________________

ENVIRONMENTAL IMPACT MATRIX

Activities Environmental Parameter

Air

Quality

Noise &

Odour

Water

Quality

Land

Environ

ment

Infrastr

ucture

Servi

ces

Environ

mental

Hazard

Housing Terrestrial

Ecology/

Land use

Socioec

onomic

Status

Aquatic

Ecology

Water

Requirement

0 0 1 0 1 1 0 0 0 1 1

Effluent

Discharge

0 0 1 1 1 1 1 0 1 0 0

Gaseous

Emissions

2 0 0 0 0 0 1 0 1 0 0

Fugitive

Emissions

1 1 0 0 0 0 1 0 1 0 0

Solid Waste

Disposal

1 0 1 1 1 1 1 0 0 0 0

Raw Material

Storage/

Transport

1 1 0 2 2 1 1 0 1 1 0

Raw Material

Handling

1 1 0 1 0 0 1 0 1 0 0

Product

Storage

1 0 0 1 0 0 1 0 0 0 0

Spills & Leaks 1 1 1 1 1 1 1 0 1 0 0

Shut down/

Start up

1 1 1 0 1 1 0 0 1 1 0

Equipment

Failure

1 1 1 0 0 1 1 0 1 0 0

Plant

Operations

1 1 1 0 1 1 1 1 1 1 0

Transport of

workers

1 1 0 0 1 1 0 0 1 1 0

Movement of

Vehicles

1 1 0 0 1 1 0 0 1 1 0

Housing

Needs

0 1 0 1 1 1 0 1 0 1 0

Utilities 1 1 0 0 0 1 0 0 0 0 0

Cumulative

score

14 11 7 8 11 12 10 2 11 7 1

____________________________________________________________________________________________________________

4 - 41

TABLE - 4.7

___________________________________________________________________________

CUMULATIVE IMPACT CHART

ENVIRONMENTAL

PARAMETER

TOTAL CUMULATIVE

SCORE

Air Quality 14

Noise and Odour 11

Water Quality 7

Land Requirement 8

Infrastructure 11

Service 12

Environmental Hazards 10

Housing 2

Terrestrial Ecology/ Land use 11

Socio Economic Status 7

Aquatic Ecology 1

4.4 CONCLUSION

It can be concluded from the matrices that the resultant impact is beneficial in the interest

of common man, the society, the state and as the country as a whole. The benefits can be

summarized as below:

� The proposed expansion project will provide quality product at lower cost to the

users.

� There should be positive impact on the socio-economic condition of the area in

terms of direct and indirect employment due to the proposed expansion project.

� Numbers of local trained persons are likely to find jobs.

� Country will save valuable foreign exchange as import of these products will be

reduced by corresponding amount.

� These products also have export potential. Hence, possibility of earning foreign

exchange.

____________________________________________________________________________________________________________ 5 - 1

CHAPTER ‐ 5 ________________________________________________________________________ ENVIRONMENTAL MONITORING PLAN 5.1 PROJECT ENVIRONMENT MONITORING PLAN

M/s. Alembic Pharmaceuticals Limited (Unit‐I) have adopted comprehensive

environmental monitoring plan which is essential to take into account the changes in

the environment. The objective of monitoring is:

• To verify the result of the impact assessment study in particular with regards to

new developments.

• To follow the trend of parameters which have been identified as critical

• To check or assess the efficiency of controlling measures

• To ensure that new parameters, other than those identified in the impact

assessment study, do not become critical through the commissioning of new

project.

To monitor effectiveness of Control Measures:

• Monitor daily, Assess effectiveness of the Control Measures being implemented,

Explore the need to modify or add new Control Measures particularly if a

violation is observed & Report weekly.

• Regular monitoring of environmental parameters will be made to find out any

deterioration in environmental quality.

• Monitoring of the proposed expansion project area will be regularly conducted.

The attributes, which merit regular monitoring, are specified underneath

Environment monitoring plan for proposed expansion plant has described in Table:‐5.1

along with Environment Components, parameter, standards to be followed, location

and frequency.

____________________________________________________________________________________________________________ 5 - 2

TABLE:‐5.1

PROJECT ENVIRONMENT MONITORING PLAN

Environmental

Component

Parameters Standards Frequency

Air Environment

AAQM at plant site As prescribed by GPCB

including PM2.5, PM10, SO2,

NOx, HCl, Cl2, HC & VOCs

Prescribed

by CPCB

Once in a month by industry in

upwind and downwind direction.

Once in 3 months by NABL Lab.

Stack emission

monitoring of emissions

sources

Parameters prescribed by

GPCB

In stack

Prescribed

by GPCB

Once In a Month by industry.

Once in 3 months by NABL Lab.

Fugitive emissions/ work

place monitoring within

the plant side

VOC Prescribed

by GPCB

Regular

Water Environment

Analysis of treated

effluent

Parameters prescribed by

GPCB

Prescribed

by GPCB

Once a day by Company.

Once a month by NABL Lab.

Ground water quality Colour, pH, TDS, TSS,

Sulphates, Chlorides, BOD3,

COD, oil and grease, etc.

Water

quality

Standards

Once a Season by Company.

Noise Environment

Ambient Noise at plant

site

Noise level in dB(A) As per

National

Noise

Standards

Once In a Month by Company.

Soil Environment

At plant site Analysis of pH,

conductivity, Sulphates,

calcium, magnesium, Cl‐

‐‐ Pre and post monsoon season by

Company.

____________________________________________________________________________________________________________ 5 - 3

5.1.1 LABORATORY FACILITIES

M/s. Alembic Pharmaceuticals Limited (Unit‐I) have its own laboratory equipped with

different equipment i.e. analytical balance, pH meter, COD heating apparatus, oven,

incubator and necessary glass‐wares. In addition to that M/s. Alembic Pharmaceuticals

Limited (Unit‐I) has quality control laboratory, which is equipped with sophisticated

equipments. Equipment of quality control laboratory is also available for analysis of

environment parameters. M/s. Alembic Pharmaceuticals Limited (Unit‐I) have a plan of

the regular monitoring to ensure that pollution is limited below prescribed limits and to

take corrective action. In case the monitored results of environment pollution shall be

found to exceed the prescribed limits, remedial actions shall be taken through the

concerned plant authorities. The actual operation and maintenance of pollution control

equipments of each department shall under respective department heads.

5.1.2 DOCUMETATION & RECORDS

The environmental department in respect of operation of pollution control facility

maintains following records.

Instruction manual for operation and maintenance of pollution control equipments.

Log sheet for self‐monitoring of pollution control equipments.

Manual for monitoring of Air, water for Ambient conditions

Instruction manual for monitoring of water, solid and gaseous parameter

discharged from the factory and also for various parameters of pollution control

facilities.

Stationary records as per the Environmental Acts.

Monthly and annual progress reports.

CHAPTER - 6

ADDITIONAL STUDIES (RISK ASSESSMENT & DISASTER MANAGEMENT PLAN)

Attached Separately

7- 1

CHAPTER ‐ 7

ENVIRONMENTAL MANAGEMENT PLAN

7.1 BACKGROUND

The industry has adopted a comprehensive Environmental Management Plan (EMP) which

covers several environmental protection measures, not only for abatement of

environmental pollution resulting from the project, but also for the improvement in the

ambient environment. The various components of the EMP are outlined in subsequent

sections. An EMP is a site‐specific plan developed to ensure that all necessary measures are

identified and implemented in order to protect the environment and comply with

environmental legislation.

7.2 OBJECTIVES OF ENVIRONMENTAL MANAGEMENT PLAN

The Environment Management area is handled by a Qualified Manager with adequate

training and experience in operation of ETP and management of other pollution control

measures. He is assisted by a Qualified Executive and one operator (in each shift) to run ETP

and other pollution control system.

All the necessary controls w.r.t. management of Liquid / Hazardous / Gaseous pollutants are

exercised.

For all liquid effluents, full fledged effluent treatment plant consisting of primary, secondary

and tertiary treatment is installed to ensure adequate treatment prior to discharge.

Process stacks are equipped at safe height with scrubbers where required to ensure

emissions within prescribed limits.

To handle hazardous waste as per Hazardous Waste (Management, Handling and

Transboundary Movement) Third Amendment Rules, 2010 of Environment Protection Act,

1986.

Hazardous waste is been disposed off at the common Incinerator / secured land fill facility

available in the nearby vicinity.

• Fixed gas detection system will be installed in the workplace area.

• Work place monitoring is carried out regularly through continuous monitoring

systems and periodic checking.

7- 2

• Ambient air quality is monitored regularly.

• Good green belt is maintained inside and outside the premises by planting trees,

developing lawns.

• To work in R&D for continuous improvement in process to reduce Pollution Load &

moving towards adopting cleaner production technology.

7.3 ENVIRONMENTAL MANAGEMENT CELL

Apart from having an environmental management plan, it is also necessary to have a

permanent organizational set up charged with the task of ensuring effective

implementation. In this effect, M/s. Alembic Pharmaceuticals Limited (Unit‐I) have assigned

responsibilities to officers from various disciplines to co‐ordinate the activities concerned

with management and implementation of environment control measures.

An organogram of Environment management cell is shown in Figure 7.1. This department

undertakes the monitoring of environment pollution level by measuring stack emissions,

Ambient air quality, water and effluent quality, Noise level, etc. either departmentally or by

appointing external agency whenever necessary. M/s. Alembic Pharmaceuticals Limited

(Unit‐I) have its own laboratory equipped with different equipment for environmental

monitoring.

M/s. Alembic Pharmaceuticals Limited (Unit‐I) carries out the regular monitoring in future as

well as ensure that pollution is limited below prescribed limits and take corrective action by

providing new pollution control equipment if required. In case the monitored results of

environment pollution are found to exceed the prescribed limits, remedial actions are taken

through the concerned plant authorities. The actual operation and maintenance of pollution

control equipment of each department is under respective department heads.

The environmental department shall also look after preparation and submission of Water

Cess Return, Environmental statement and Consolidated Consent & Authorization

application/ renewal under water (Prevention and Control of Pollution) Act, 1974, Air

(Prevention and Control of Pollution) Act, 1981, Ambient Air Quality as per NAAQ Standards,

7- 3

2009 and Hazardous Waste (Management, Handling and Transboundary) Third Amended

Rules, 2010 under Environment Protection Act, 1986.

FIGURE ‐ 7.1 ORGANOGRAM OF ENVIRONMENT MANAGEMENT CELL

DIRECTOR / CEO

GENERAL MANAGER

MANAGER / ASST. MANAGER

EXECTUTIVES / OFFICERS

OPERATORS

7- 4

7.3.1 ENVIRONMENT POLICY

7.3.2 CORPORATE ENVIRONMENT RESPONSIBILITY

• To develop & to promote the technology having minimum pollution of Air, Water &

Land.

• Educating & promoting staff & workers for creating safe working atmosphere.

• More & more tree plantation in the surrounding open area within site.

7- 5

7.3.3 MANAGEMENT RESPONSIBILITY

• Director/CEO is overall responsible for effective implementation of Occupational

Health, Safety & Environment Management System (HSEMS)

• Core Committee conducts management review every Six months to assess the

effectiveness of HSE Management System. If necessary the committee allocates

resources for taking Corrective and Preventive action on Non‐Conformance.

• The Core Committee advises and monitors the establishment and implementation of

HSEMS

• HODs, Dept. in‐charges, Supervisors, are responsible for implementing HSE

Management Programs. Safety Officer to lead the programme. All the employees are

responsible for implementing and maintaining HSE Management System.

• HODs are responsible to define and monitor the key characteristics for measure of

performance in HSE. HODs are responsible for control of all the documents and data

as per the requirement of ISO‐14001 and OHSAS 18001

• Verification activities, including internal HSE Audits, are carried out at the direction of

Core committee and team of Internal Auditors.

The organization structure of expansion unit of M/s. Alembic Pharmaceuticals Limited (Unit‐

I) at Survey No. 119, 120 & 121, At & Post: Panelav, Tehsil: Halol, Dist. Panchmahal, Gujarat,

will be as per Organization Chart. The Roles, responsibilities, accountabilities and authorities

of key personnel have been defined in the following paragraphs:

7- 6

ROLE – 1: GENERAL MANAGER (OPERATION HEAD)

RESPONSIBILITIES:

• He is responsible for entire activities of Unit.

• He is responsible to define HSE policy and ensure that this policy is understood,

implemented and maintained at all levels in the organization.

• He is also responsible to provide adequate resources for achieving improved

Occupational Health Safety and environmental performance

• He is responsible for setting organizational HSE objectives and targets.

• He is also responsible to review HSE management system at appropriate intervals, to

ensure its continuing and effectiveness. Monitoring of effectiveness of the system shall

be done through Management Reviews

• He is also responsible to appoint Management Representative and extend support and

resources in implementing HSE management system.

• He is responsible for procurement of raw material (Indigenous & Imported) and

engineering goods as per the specifications

• He is overall responsible to ensure that legal requirements are met as per the legal

register.

• Review the implementation of HSE Management System and its effectiveness, at

appropriate intervals, to ensure continual improvement of the organization’s overall

performance

In absence of General Manager, other unit’s Operations Head oversees his functions. CEO

also may look into the delegation of authority, during his absence.

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ACCOUNTABILITY

He is accountable for all operations being carried out in the organization. His scope of

accountability in terms of HSE is as follows

1. Establishment, operation and maintenance of ISO 14001 and OHSAS 18001 systems

in all spheres of manufacturing site.

2. Review of performance and progress of the management systems by periodic

review through Management review.

3. To ensure availability of resources essential to establish, implement, maintain and

improve the HSE management system.

MRM INCLUDES

1. The AMR shall obtain the findings of statutory inspection and testing reports from

concerned departments and present in the management review meeting for

discussion and action

2. The minutes of the Management Review Meeting are recorded and circulated to all

members of the HSE Apex Committee.

Assistant MR shall prepare minutes of meeting within two days after the meeting. He shall

ensure that the review outputs are recorded in the “Action decided” column of format of

Minutes of Management review meeting.

7.4 ENVIRONMENT MANAGEMENT PLAN

The Environment Management plan is meant for mitigation/ management of the adverse

impacts and the strengthening positive impacts during proposed expansion project.

Environment Management Plan is tabulated in Table:‐7.1

7.4.1 CONSTRUCTION PHASE

During Construction Phase sanitation facilities are required. Temporary facilities shall be

made available to construction personnel. Necessary PPEs shall also be provided.

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• Sanitation

The site should be provided with adequate and suitable sanitary facilities to maintain proper

standard of hygiene for construction workers. These facilities should include water supply,

sanitary toilets, rest room, etc.

• Noise Environment

Noise effect on the nearly habitation during construction activities will be negligible as the

nearest habitat is more than 0.9 km from the plant. However, construction labor would be

provided with noise protection devises like ear muffs and occupational safety ware, as per

requirement. And noise generating equipment shall be stopped during night hours.

• Construction Equipment & Waste

The waste oil generated by construction equipment, if any, would be disposed through

authorized recyclers and unauthorized dumping of waste oil shall be avoided. Other wastes

shall be disposed‐off by adopting environmentally compatible methodology.

• Storage of Hazardous Materials

The hazardous material such as lubricating oils, compressed gases (for welding), paints,

varnishes, etc. are required to be stored at the site during construction phase. Since, these

materials are hazardous in nature; they shall be stored as per the prescribed / accepted

safety norms.

• Solid / Hazardous Waste Disposal

The hazardous materials used during the construction may include petrol, diesel, welding

gas and paints. These materials would be stored and handled according to the guidelines

specified under Hazardous Waste (Management, Handling & Trans‐boundary Movement)

Third Amendment Rules, 2010 by MoEF. Some of the precautions of storage and handling of

the hazardous materials and waste includes the following:

Dyke enclosures would be provided where‐ever necessary for storage of hazardous

materials.

Diesel and other fuels would be stored in separate dyke enclosures.

7- 9

Separate storage for waste paints and thinners, contaminated rags and brushes to

facilitate recycling and reuse. Rags could be laundered for reuse.

Vehicle maintenance area to be selected properly, to prevent contamination of soil

and ground water by accidental spillage of oil, and other wastes

TABLE:‐7.1

ENVIRONMENT MANAGEMENT PLAN

ENVIRONMENT

ISSUE/COMPONENT

REMEDIAL MEASURES

Hazardous waste generation &

disposal

Proper collection, Safe Handling, Storage within premises and

disposal of waste at approved TSDF, incineration facility, re‐

cyclers, re‐processors.

Effluent generation and

treatment

New Effluent treatment plant will be provided for treatment of

wastewater generated from new project.

Emission from stack Adequate pollution control system will be provided for control of

gaseous emission.

• Adequate stack height for better dispersion of pollutants

• Scrubbers at Process Vents

Noise Acoustic enclosure on DG sets, engineering control at high noise

level areas like compressors etc, wherever feasible, proper oiling,

lubrication and maintenance of equipment, development of

greenbelt around plant boundary and inside plant

Greenbelt 35% of the plant area is developed as greenbelt.

Rainwater harvesting Rainwater harvesting will be provided in non‐plant area.

Information and awareness about

hazardous chemicals plant

Awareness and information will be provided within 5 km of the

study area about the hazardous situations.

Preparedness to handle onsite &

offsite emergency

Onsite & Offsite Emergency Management Plan will be prepared

Monitoring of Environmental

parameters

Regular monitoring of various environmental parameters will be

carried out to check the effectiveness of the control system.

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7.4.2 WATER ENVIRONMENT

Water requirement shall be met through own bore well (ground water). However, record of

water consumption for different usages should be maintained.

Water Pollution and Its Mitigation Plan

Total fresh water requirement will be 160 m3/day which shall be met through own bore well

& 237.5 m3/day of Recycled Water i.e. 397.5 m3/day of total water consumption. The

wastewater generation will be 195 m3/day (Industrial) & Domestic wastewater of 50 m3/day

shall be treated in ETP. Out of 245 m3/day Waste water generation, 237.5 m3/day Waste

water is reused as it is RO permeate water, 5 m3/day is recovered Solvent and 2.5 m3/day is

MEE Concentrate

Construction Phase

• The drinking water and sanitation facilities at the project site are available to the

construction work force. This is necessary to reduce pollution of any receiving water

body and also to prevent hazards due to water borne vectors.

Operation Phase

• Wastewater from Industrial Operations will be treated in effluent treatment plant then

it goes to MEE and MEE Condensate will be reused in plant premises. Domestic Waste

water will be disposed by septic tank & soak pit.

• Annual environmental audit will be carried out every year from recognized Schedule‐I

environmental auditor.

• Records of analysis results of treated and untreated wastewater along with MLVSS in

aeration tanks should also be maintained.

• Adequate spares for effluent collection, handling, treatment and disposal system should

be maintained.

• Proper housekeeping should be adopted to prevent spillages and contaminated surface

runoff going to storm water drains.

• The additional treated wastewater would also be utilized in cooling tower. The following

measures would be taken to minimize the water usage in the operational phase:

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Endeavor to reduce the actual process water consumption by way of improvement

in operation of processing units.

Water saving by shower head flow controls, spray taps and faucet aerators and

photo‐sensitive taps.

Exploring other options of reusing the treated effluent besides fire water make up or

for horticulture development.

7.4.3 AIR ENVIRONMENT

M/s. Alembic Pharmaceuticals Limited (Unit‐I) proposes expansion of APIs in Existing Unit at

Survey No. 119, 120 & 121, At & Post: Panelav, Tehsil: Halol, Dist. Panchmahal, Gujarat.

There are 11 types of source of air pollution in Existing Scenario & 5 types of additional

source of air pollution in Proposed Scenario at M/s. Alembic Pharmaceuticals Limited (Unit‐

I) i.e. stack attached to Boiler, Incinerator, Thermic Fluid Heater & Process Vents. Bag Filter,

Alkali Scrubber, Quencher & Alkali Scrubber & Chilled Water Circulation are installed to

prevent air pollution. ESP (Dry Horizontal type with 3 fields), Alkali Scrubber & Chilled Water

Circulation will be installed to prevent air pollution. The baseline ambient air quality

monitoring is carried out during study period (October’ 14 to December’ 14) around Project

site (within the study area), clearly reveals that the concentrations of PM10, PM2.5, SO2, NOX,

HCl, Cl2, O3, Pb, CO, NH3, C6H6, Benzo (a) Pyrene (BaP), Arsenic (As), Nickel (Ni) & VOCs are

well within the prescribed limits as per the National Ambient Air Quality Standards for

residential & Industrial.

• The major sources of air emission from the proposed expansion project are:

1. Non point sources emissions

2. Point source emissions

3. Fugitive emissions

7.4.3.1 ACTION PLAN TO CONTROL AMBIENT AIR QUALITY AS PER NAAQ STANDARDS:

Control Measures:

The design stage endeavors to mitigate the problems related to environment and health at

the process technology/ source level itself. Besides standards, emphasis would be given to

comply with all design standards/ regulatory norms as specified by CPCB/MoEF/GPCB etc.

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Following measures would be taken right from the design stage to ensure compliance with

applicable regulatory standards:

Construction Phase (Non point sources emissions)

Generation of suspended particulate matter is a common phenomenon due to

transportation of constructions materials. This would be mitigated by allowing the vehicles

entering the premises under cover. Emission of fugitive dust due to movement of heavy

vehicles etc. shall be controlled by spraying water in the affected zone. Hosing down the

wheels of the vehicles with water and providing washing troughs for them would further

mitigate the amount of dust generated. In addition, emission of other pollutants from

construction machinery using diesel driven prime movers, will be controlled by proper

maintenance.

Operation Phase (Point sources emissions)

In‐plant Control Measures: Some of the mitigation measures, which can reduce the impact

on air environment, are as follows:

• Ensuring the operations of various process units as per specified operating guidelines/

operating manuals.

• Strict adherence to maintenance schedule including lubrication for various machinery/

equipment.

• Emission at M/s. Alembic Pharmaceuticals Limited (Unit‐I) will be in the form of the gas

emission from stack attached to Boiler, Incinerator, Thermic Fluid Heater & Process

Vents. Moreover, regular monitoring of stacks are carried out to check the emissions.

Records are maintained for changing of scrubbing media on printed logbook. In case

emissions exceed, the corrective measures are immediately taken and records of the

same are maintained.

• Regular ambient air quality monitoring is carried out within premises and in the nearby

area for PM10, PM2.5, SO2, NOx & VOCs.

• A greenbelt around the factory is developed for reducing the air pollution and

attenuation of noise.

• Adoption of good house‐keeping.

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7.4.3.2 INFORMATION FOR CONTROL OF FUGITIVE EMISSIONS

The emissions are normally defined as emissions to the atmosphere resulting from leaking

piping sources and equipments such as valves, flanges, pump seals, connections, and

compressor seals open end lines and pressure relief valves. The emissions are not visually

observed but can be measured in relatively low concentration at each area of source.

Fugitive emissions are expected to be generated during construction and operation stages

of the proposed expansion project. During construction stage, main source of fugitive

emission is dust which is expected mainly due to movement of vehicles carrying

construction material and vehicles used for construction. During operation stage, leakage

through valves, pumps, emission from open drum containing chemicals, open feeding;

storage tanks, etc. are the major sources of fugitive emissions of organic chemicals and

VOCs. Excess use of solvent may also results fugitive emission from the process vessels.

The above will be controlled by having proper scrubbing system with a provision of primary,

secondary and tertiary scrubber, boiler stacks will be provided with multicyclones/bag filters

to take care of particulate matter, Condenser to trap VOC, solid raw material charging will

be done through closed system. Proper maintenance schedule will be adhered to avoid

emissions through flange joints, pump seals etc. Proper gland packing is always maintained

for pumps and valves and to the extent possible pumps will be with mechanical seal.

M/s. Alembic Pharmaceuticals Limited (Unit‐I) shall have fully closed system. Adequate dust

collector will be installed for control of fugitive emission during loading of raw material and

product. Condenser will be provided to trap VOC. All the Flange joints of the pipe lines

which carry solvents will be covered with flange guards. All the rotating equipments like

pumps will be installed with Mechanical Seals to arrest any sort of emissions. VOC detectors

will be installed at various places to identify any fugitive emissions. A regular preventive

maintenance schedule will be in place to replace or rectify all gaskets and joints etc as a part

of ISO systems to ensure no fugitive emissions shall take place.

Following measures will be adopted to prevent and control fugitive emissions:

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1. Airborne dust at all transfers operations/ points will be controlled either by spraying

water or providing enclosures.

2. Care will be taken to store construction material properly to prevent fugitive

emissions, if any.

3. Adequate ventilation will be provided.

4. Regular maintenance of valves, pumps, flanges, joints and other equipment will be

done to prevent leakages and thus minimizing the fugitive emissions of VOCs.

5. Entire process will be carried out in the closed reactors with proper maintenance of

pressure and temperature.

6. Periodic monitoring of work area will be carried out to check the fugitive emission.

7. Breather valves will be provided on solvent tanks.

8. Solvent tank vents will be connected to vent chillers.

9. To eliminate chances of leakages from glands of pumps, mechanical seal will be

provided at all solvent pumps.

10. Stand by pumps will be provided on all scrubbers. Besides, scrubbers will be

equipped with on‐line pH meter with hooter system for better operational control.

11. Close feeding system will be provided for centrifuges. Centrifuge and filtrate tank

vents will be connected to vent chillers.

12. Minimum number of flanges, joints and valves in pipelines.

13. Regular inspection of floating roof seals and proper preventive maintenance of roofs

and seals for tanks

14. Fugitive emission over reactors, formulation areas, centrifuges, chemical loading,

transfer area, are collected through hoods and ducts by induced draft and

controlled by scrubber/ dust collector.

15. Dedicated scrubbers are provided are used for fugitive emissions to control

16. For dust emissions, cyclones / bag filter provided.

17. Emphasis has been given to solvent management / solvent loss prevention as

shown in the solvent management plan.

18. Enclosures to chemical storage area, collection of emission from loading of raw

materials in particular solvents through hoods and ducts by induced draft, and

control by scrubber / dust collector to be ensured.

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19. Nitrogen blanketing, provided, besides special care needs to be taken for control

in respect of odorous chemicals.

7.4.4 NOISE ENVIRONMENT

The sound pressure level generated by a noise source decreases with increasing distance

from the source due to wave divergence. The propagation and attenuation of noise pressure

wave is dependent on many parameters amongst which, the medium of travel and the

ambient conditions are the most significant parameters. In order to minimize adverse

impact on the noise environment, due attention shall be given for implementing noise

control measures. Comprehensive measures shall be taken at design stage for noise from

proposed expansion unit. The measures are as under:

• The noise level at the plant boundary shall be restricted to 75 dB(A) during day time and

70 dB(A) during night time.

• Noise level shall be specified for various rotating equipment as per Occupational Safety

and Health Association (OSHA) standards.

• Equipment lay‐out shall be done considering segregation of high noise generating

sources.

• Erection of suitable enclosure, if required, to minimize the impact of high noise

generating sources.

• There may be small addition to the ambient noise level, due to the increased

transportation activities. This creates a slight adverse impact on the sound environment.

• Regular oiling, lubrication and maintenance of the equipment shall be carried out to

minimize noise generation.

During Construction Phase

Following measures shall be taken for abatement of noise during construction phase:

• Noise emissions from construction equipment will be kept to a minimum by regular

maintenance.

• Heavy and noisy construction jobs shall be avoided during night hours.

Following measures shall be adopted for abatement of noise during operation phase:

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• Acoustic laggings, enclosures and silencers shall be provided wherever necessary for

high noise generating equipment.

• Sound proof glass paneling shall be provided for all operating stations / control rooms as

well as for shift rooms at critical places.

• Strict implementation/ compliance of all statutory norms w.r.t. noise generation,

occupational exposure shall be done.

• Use of personal protective devices such as ear‐muffs and ear‐plugs shall be strictly

enforced.

• Acoustic barriers / shelter shall be developed in noisy workplaces.

• Noise generating sources in the plant areas shall be monitored regularly. Monitoring of

ambient noise levels should also be carried out regularly both inside the premises as well

as outside the greenbelt.

During Operation Phase

However, due to the attenuation of noise level within the factory and due to the fact that

the project site is situated in a well developed industrial estate and not in the immediate

vicinity of human settlement, significant impact is not expected in the nearest present

human settlement. The volume of transport vehicles to be handled is very low. The

company shall develop a green belt around the periphery of the premises, which shall act as

a barrier to the propagation of noise from the factory premises. This shall further reduce the

noise levels appreciably.

• It is recommended to measure and maintain records of noise level at various places

within and outside factory premises.

• Manufacturers/ suppliers of major noise generating equipment/ machines like

compressors, turbines, generators should be asked to take required measures for

minimizing the noise levels generated by machines by using noise absorbing material

for various enclosures or using appropriate design/ technology for fabricating/

assembling the machines.

• Audiometric tests should be conducted periodically for the employees working close

to the high noise sources.

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7.4.5 LAND ENVIRONMENT

7.4.5.1 HAZARDOUS WASTE MANAGEMENT

Twelve categories of hazardous wastes will be generated from the proposed expansion

Project. Treatment, Storage & Disposal mode for the same will be followed as per Hazardous

Waste (Storage, Handling & Trans‐boundary Movement) Third Amendment Rules, 2010.

Record of hazardous waste generation and disposal shall be maintained on printed logbook.

All necessary precautions shall be taken during handling, loading and unloading of

hazardous wastes.

Storage of Hazardous Waste:

• Hazardous waste shall not be stored for a period more than 90 days. And shall maintain

records and make them available for inspection.

• Store at a designated Onsite‐secured area with impervious floor that affords protection

from sun & rain fall, spreading of leachate, mixing of wastes etc.

Transportation of Hazardous Waste:

• Properly packed & labeled waste transport through dedicated vehicle to a captive

facility/ authorized TSDF facility.

Disposal of Hazardous Waste:

• Used Oil, Spent Solvent, Process Residue, Spent carbon & Hyflow, Spent Mother Liquor,

Discarded Drums, ETP Sludge, Filler & Filter Material, Incinerator Ash, Off Specification

Product / Date Expired Product, Fly Ash & Evaporation Salt. All the Solid/Hazardous

Waste generated will be disposed as per the norms.

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7.4.5.2 IDENTIFICATION OF RECYCLE/REUSE, CLEANER PRODUCTION AND CO‐PROCESSING

OPTION OF HAZARDOUS WASTE

• It is recommended to analyze each hazardous waste periodically and maintain records.

• Check the calorific value of the ETP Sludge and then explore possibilities of Co‐

Processing in Cement Industry as Primary fuel. Waste materials used for co‐processing

are referred to as alternative fuels and raw materials (AFR).

1. On‐site recovery of solvent in distillation column. Recovered solvent will be recycled

back for re‐use and residue will be sent for incineration.

2. All the non‐biodegradable effluents generated from plant will be converted into

biodegradable effluents followed by conventional treatment in wastewater

treatment plant. Treated effluent will discharge to deep sea as per GPCB norm.

3. Second wash of plant/ equipment will be re‐used as first wash in the same equipment/

reactor to reduce fresh water consumption.

Solid Waste Contaminated with Hazardous Material: Use Proper Decontamination Process treatment separately and recycle/reuse/sell only Decontaminated Wastes (Ash, 25% NH3 Solution and NH4Cl Solution)

Hazardous Wastes (HWs) generated from the Premises

Properly Segregate, Label and store in Roofed Designated secured storage area with impervious Flooring & Leachate Management System as per the Guidelines

Leachate to ETP for further treatment

Use proper safety and personal protective equipment while handling HWs

Disposable HWs of Secured TSDF: ETP Sludge, Chemical containing residue, Sludge from treatment of waste water arising out of cleaning/disposal of barrels/containers

Incinerable HWs:Process Waste, Distillation Residues, Date expired or discarded product, off‐specification products

Reusable, Recyclable, Recoverable HWs: Used Oil, Discarded drum/ Containers of PP/HDPE bags/Liners

TSDF Site

Common Incinerator Site Reuse/recycle within the plant premises offer necessary

treatment (if required) OR Sell to the authorized reprocessor/ recyclers/ end users

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7.5 GREEN BELT DEVELOPMENT

Tree plantation is known for improving the aesthetic and climatological environment of an

area and properly designed green belt can help in ameliorating air pollution to a very

significant degree. It should be borne in mind that the green belt will be most effective as a

sink for particulate matter and gaseous emissions from ground level sources, such as,

fugitive emissions. Effectiveness of green belt for the elevated sources is rather limited but

its action as a green lung greatly helps in improving the air quality of the area. However,

considerable scope exists for strengthening the existing green belt and developing the same

in future.

BREAK UP OF DIFFERENT LAND USE OF FACTORY

Total 68,530.26 m2 land area is available at site; out of this 24,000 m2 (i.e. approx 35 % of

total area) is developed as greenbelt and other forms of greenery.

Good greenery is maintained in and around the site by planting various types of tress and

maintaining lawns. 24,000 m2 area (approx.) is utilized for tree plantation / development of

lawns. A green belt with width of min. 1 meter is developed within the site boundary and

across the premises inside roads. Trees like Asopalav, Neem, Gulmohar, Champa, Gauva,

Palm Trees, Nariyal, Ghaneri, Shevga, Jangli badam, Sag, Jamun, Mango, Rain tree, etc. are

planted in and around the site.

Green Belt to Trap and Absorb Pollutants

A green belt traps and absorbs pollutants without altering the biogeochemical cycle of

water and nutrients. Absorption and trapping capacity of trees depend on height of plant,

canopy structure, physiognomy and morphological character of leaf. Once fully developed,

such tree plantations can serve as buffer and shock absorber against transient and

accidental release of pollutants caused by power, equipment and human failures. Green belt

is usually designed in such a way that the first few rows in a green belt have a shorter height

and dense canopy. Plants native to an area are generally used to suit the prevailing

ecosystem and biogeochemical cycle. Native plants are more tolerant to disease, grow at a

faster rate and result in better attenuation of pollutants.

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Plantation Design

In view of the different functional requirements of the plant in an industrial area, the

pattern of plantation within plant is discussed as below:

A. Curtain Plantation

To help in restrict the movement of pollutants from inside to outside and from outside to

inside, a thick green belt shall be developed at the peripheral limits of the plant along the

boundary walls whenever feasible. The curtain will be an effective buffer against gases, dust

and noise.

B. Avenue Plantation

Linear plantations along road‐sides help reduce air and noise pollution from automobiles as

well as general emissions from the industrial units. To combine bio‐aesthetic and pollution

abatement needs, parallel rows of trees (inner and outer rows) shall be planted on the roads

and boundary.

C. Field Plantation

Plantation on the open stretches of land helps improve the general ecological conditions of

the habitat by adding greenery to the landscape and by providing a vast canopy of foliage

for sink of pollutants generated in the area. The open land spaces, not used for industrial

purposes, shall be filled with plant species.

D. Ornamental Plantation

The immediate area of each building shall be arranged into a lawn, fringed by flower beds.

In some strategic corners flowering climbers been used to highlight the visual effect.

Plantation Details

Actual Status of Plantation/Green Belt

Trees species to be planted at plant are in line with trees species recommended in CPCB’s

guidelines for developing Greenbelts. For plantation at the plant in future, it is suggested

that these guidelines should also be followed for selecting pollutants tolerant and absorbent

species.

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(a.) Species of tree planted

Green Belt Avenue Trees Shrubs Above 3m height Below 3m height Jamun Alstonia Bamboo Pentas var. Gulmohar Pinkcaassia Bahunia Galphemia Peltophorum Spethodia Large stomia Miniature bamboo Kasid Paras, papal Cordia Jestropha Gultora Pendula Karen Hibiscus var. Karen Gulmohar Gulltora Braya Kapop Jackranda Tecoma var. Palmbago capensis Neem Bignonia Tagari Acalypha var. Arjun Largestomia Russolia Sisoo Cadamba Duranta var. Australian babul Lantana var. Nilgiri Cassia biflora Babul Ixora var. Pangara Vinca Cassia fistula Croton Cana

(b.) Co‐relation of Trees with pollution control

Trees Air pollution Dust Noise Salt Trees Nilgiri Karen Pendula Neem Neem Pangara Pendulla Bahunia Peltophorum Gulmohar Babool Neem Paras pipal Jamun Cadamba Bogunvelia Cassia fistula Pendula Vinca Croton Tecoma var. Spethodia Alstonia Gulmohar Jackranda Places: Green‐Belt Plant Area Plant Area Plant Area

And green belt

Plant Area

GREEN BELT DEVELOPMENT PROGRAMME

YEAR NO. OF TREES/PLANTS TO BE PLANTED IN PLANT AREA

2015‐2016 500 2016‐2017 400 2017‐2018 400 2018‐2019 300 2019‐2020 300

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7.6 OCCUPTIONAL HEALTH AND SAFETY

Health hazards associated with the occupation are called occupational hazards. In chemical

industry due to handling of toxic and hazardous chemicals there are possibilities of

developing occupational diseases. M/s. Alembic Pharmaceuticals Limited (Unit‐I) shall carry

out the following checks to curb the problem:

i) Pre ‐ employment medical check up at the time of employment.

ii) Annual medical check up shall be done for all employees.

iii) First aid training shall be given to the employees.

iv) Monitoring of occupational hazards like noise, ventilation, chemical exposure shall

be carried out at frequent intervals, the records of which shall be documented.

OHC Room will be provided at Security building. Professional doctor will be called every

week at factory. And routine checkup of all employees will be carried out annually for all

standard tests needed as per Factory Inspector Office. Employees will be trained frequently

through special master faculties on various points related to occupational health to create

more awareness on the subject. All precautions shall be taken to avoid foreseeable

accidents like spillage, fire and explosion hazards and to minimize the effect of any such

accident and to combat any emergency at site level. Some of the preventive safety

measures shall be taken to minimize the risk of accident with respect to Technical Safety,

Organizational Safety and Personal Safety are listed below:

• Company shall take all reasonably practicable measures to minimize the risk of such

accident in compliance with the legal obligation under the relevant safety.

• All building plans and installations shall be as per relevant acts and duly approved by

competent government authorities.

• Process and Equipment shall be designed by qualified and experienced professionals

and fabricated to applicable national / international codes with stage wise

inspection.

• Pressure Relief Valves and rupture disks shall be installed on the reactor and jackets

wherever required.

• Hazardous processes shall be operated by trained workers and shall be looked after

by qualified & experienced supervisors.

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• Safety features such as fire extinguishers, fire hydrant system and suitable Personal

Protective Equipment (PPE) shall be provided. Regular operations and testing of fire

hydrant system and fire extinguishers shall be carried out.

• Suitable provisions for control of critical process / storage parameters within

specified safe limits (use of pressure relief valves, rupture discs, safety valves, trip

circuits, wherever necessary) shall be done.

• Use of flameproof electrical equipment, flame arresters and breather valves shall be

done.

• Provision of Earthing and lighting arrestor to prevent electrical fires and explosions in

flammable / explosive chemicals storage / processing areas shall be done.

• Tanks storing hazardous liquid chemicals shall be provided with dyke wall to confine

any spillage and facilitate easy collection. Necessary separation distance shall be

maintained.

Personal Protective Equipment (PPE) like goggles, safety shoes, helmet, apron, earplugs,

facemask & clothing shall be provided to employees as per the job requirements. The

company shall prepare a comprehensive on‐site emergency plan with well‐defined

responsibilities to face any eventuality caused under adverse circumstances and unforeseen

reason.

7.7 INFORMATION FOR RAIN WATER HARVESTING

Rain water harvesting refers to the collection and storage of rain water and also other

activities aimed at harvesting surface and ground water, prevention of losses through

evaporation and seepage and all other hydrological studies and engineering interventions,

aimed at conservation and efficient utilization of the limited water endowment of

physiographic unit such as a watershed. The total amount of water that is received in the

form of rainfall over an area is called the rainwater endowment of that area. Out of this, the

amount that can be effectively harvested is called the water harvesting potential.

Rain Water can be harvested for two purposes:

• Stored for ready use in containers above ground or below ground

• Charged into soil for withdrawal later i.e. ground water recharging

The main elements of rain water harvesting systems are:

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• Catchments

• Conduits

• Storage facility

• Recharge facility

The proposed expansion project will have rain water harvesting system with ground water

recharge technique by using rain water from non‐process buildings and roof top water of all

other buildings. All storm water drains are routed such as to reach extreme corner of site &

then shall harvest the same to ground water through well. Various kinds of recharge

structures are possible which can ensure that rainwater percolates in the ground instead of

draining away from the surface. While some structures promote the percolation of water

through soil strata at shallower depth, others conduct water to greater depths from where

it joins the ground water. Besides, possibility will be explored to utilize uncontaminated rain

water in cooling towers during monsoon.

Maintenance of the recharging system:

Periodic maintenance required for reliable and higher quality water supply. During raining

season the entire system to be checked before and after rains and cleaned after every dry

period. Before first shower storage tanks should be cleaned and flushed of all sediments and

debris.

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7.8 MEASURES FOR CONSERVATION OF ENERGY

M/s. Alembic Pharmaceuticals Limited (Unit‐I) shall adopt various measures for energy

conservation:

• Energy efficient machineries will be used during operation phase.

• Installation of economizer & high efficiency burner on steam boilers

• Company shall try to utilize renewable sources of energy for conservation of non‐

renewable sources of energy.

• Enough care will be taken to prevent/minimize energy losses at each stage.

• Energy audit will be used as a tool for monitoring purpose.

• External lights will be controlled through timers for auto on/off function based on

timings.

• The cable size will be selected so as to minimize the power losses.

• The power factor improvement capacitors will be provided individually for AC loads.

• Using water cooled chillers, variable frequency drives for secondary pumps and

public area and building management system for HVAC equipments with non‐CFC

and non‐HCFC based refrigerants.

• Use of VFDs for various utilities in variable load application to optimize pump and air

handling unit performance, wherever required.

• Automated day light control.

• Efficient lamps and ballasts.

• Automated control for external lighting (Astronomical/Sensor)

• Occupancy Sensors.

• Phase‐wise implementation of Advance Process Control (APC) in the process plants

• Replacement of conventional lighting fixture by more energy efficient fittings.

• Installation of improved insulation over the High Pressure (HP) steam line to reduce

the heat loss.

• Use of FRP blade on Cooling Tower

Company shall explore possibility of use of solar energy for various infrastructure

operations. Also use of Energy Efficient Lighting, Transformers, HVAC system, Use of Energy

Efficient Motors, electrical appliances to minimize the energy consumption in addition to

Process Planning.

7- 26

7.9 NATURAL RESOURCES CONSERVATION

The substances that are found in nature and are used by the man for his welfare directly or

indirectly are called as natural resources. Sun, wind, soil, fossil fuels, wood, forest, flora and

fauna are some of the examples of natural resources. The judicious or wise use of natural

resources in such a way that the present generations make use of natural resources without

compromising the needs of the natural resources for the future generation is called

as conservation of natural resources.

Conservation of Natural Resources

As natural resources are beneficial to human beings, maintain ecological balance and at the

same time are in a threat of getting depleted due to its indiscriminate over exploitation,

there is an urgent need for conservation of natural resources. This can be accomplished by

the following ways:

• Alternative forms of energy such as solar energy etc. shall use more in comparison to fossil fuels.

Alternative forms of energy are eco‐friendly, do not cause pollution and are renewable.

• Avoid using plastics, synthetic materials etc as these materials cause damage to the soil.

• Water is precious natural resources and hence avoids wasting water. Taps shall be closed when

not in use.

• Natural gas shall be used as a source of fuel in Boiler.

• Adopt 3 R's for conservation viz, Re‐use, Reduce and Re‐cycle.

• Trees shall be planted along roadsides, railway tracks and waste lands and deforestation should

be avoided.

• Don't waste electricity. Fans and lights shall be switched off when not in use.

7.10 SKILLED AND TRAINED MANPOWER

Employment would be as per prevailing norms of state government for skilled and trained

people for the proposed expansion project. The company has sufficient skilled manpower for

the existing project and our technical, administration and other staff are sufficient to take

care of the proposed expansion plant. M/s. Alembic Pharmaceuticals Limited (Unit‐I) will

give employment to about 602 employees (Existing: 567 + Additional Proposed: 35)

(Including Contract workers).

7- 27

7.11 SOCIO‐ECONOMIC DEVELOPMENTAL ACTIVITIES

Apart from business, M/s. Alembic Pharmaceuticals Limited (Unit‐I) is devoted to social

commitments and will continue to do the same as per the needs of nearby village people.

For Corporate Social Responsibility, Various Programs/ Projects related to Social & Economic

development of surrounded area has been planned, which are as follows, Planned for

providing Water purifier for Village people, conducting medical camps for Cataract

operation, pregnant women check up & Senior Citizen Check‐up, deputing teacher for

literacy development to Senior Citizens. Other such activities as stated as below:

Activities carried out as a Socio‐Economic Welfare Scheme by Rural Development Society

We (Our Chairman and Managing Director, Shri Chirayubhai Amin) have formulated a rural

development society on 17/12/1979, named as GRAM VIKAS with a noble objective to work

for the total sustainable development and continual improvement of the local area villages

and its people. The objectives and achievements / contributions of the rural development

society are mentioned hereunder in brief.

Objectives:

• To upgrade the standard of living of the villagers, ensure good health, and develop

them.

• To improve the financial position of the people.

• To train the villagers as to how to make use of modern technology for their

development.

• To educate them regarding the mental and psychological ill effects caused due to

consumption of liquor, tobacco and cigarettes.

• To make women and men capable of developing themselves.

• To remain involved mainly on health and prohibition related matters.

Achievements / Contributions:

• In all 39 villages have been covered and contacted from surrounding Halol, Kalol and

Jambughoda talukas.

• Total 8 training programs have been conducted on health.

7- 28

• Solar cookers at a discounted price have been installed in 17 villages in Panchmahal

district, under the sponsorship of Gujarat Energy Development Corporation.

• Total 6000 nos. of smokeless “Sigris” i.e. Cooking stoves have been given in villages.

• Vocational training programs have been conducted to develop facilitates self

employment initiatives. The training has been given to both men and women on

subjects like, Hosiery, Carpentry, Oil crusher repairing, Motor rewinding, welding,

Electrician, Masonry, Detergent powder making, Acrylic fabrication, Garment making,

Food processing, Computer, House wiring, plumbing, cotton hosiery, embroidery,

Agarbatti making, Masala making, etc.

• The Panelav Industrial Cooperative Association has the objective of assisting the

marketing of the products, manufactured by the trained villagers in vocational training

programs.

• Khadi Gramodyog has also given training to make people capable of securing jobs.

• For the development of women, and making them independent they have been given

guidance as to how to make savings, how to get loan, and how to utilize the same for

the own children and social work.

• Almost 600 women have been given the vocational training to start cottage industry on

their own. Also legal advisory center has been started for women to avail legal guidance.

• For the development of youth, educational workshops have been organized by youth

club. Workshop on Leadership training, involvement in cultural activities, arranging

sports events etc. are done for the overall physical and mental development. Similar

activities are undertaken for young girls.

• Education is provided for Child development, activities like arranging competition for

‘Healthy Baby’, Sports camps, training on Yoga, introduction to natural resources,

medical checkup etc. are done for children.

• Under the water shed development program activities like building dam, development

of agricultural land, horticulture, animal husbandry, forestation, water treatment and

human resource development.

• For agricultural development, farmers are given knowledge by calling experts from

Agricultural Science Center, regarding use of modern technology equipment, effective

use of manure etc.

7- 29

• Farmers are educated for plantation of trees and harnessing the crops, which are natural

resources for preparation of Ayurvedic medicine.

• Magazine is published named as “Panelav Vikas” in which various subjects are covered

for rural development.

Other various activities viz. Exhibitions, seminars, celebration of national women’s day,

sports, and cultural programs.

A) Natural Resource Management – The main focus of this program will be to maximize the

yield returns of the farmers through efficient management of existing resources & extension

of new agricultural practices.

1) Integrated Agricultural Growth Project – For improvement and use of the modern

techniques and thereby would certainly contribute to prosperity in the agriculture

sector and reduce the rural poverty by programs like Farmers Training, Nursery

Growing Trainings, Modern agriculture equipment distribution programs etc.

2) Animal Husbandry Projects – Various programs like health checkups & treatment,

vaccination program, Anti sterility camps, breed improvement etc. will be carried

out.

B) Income Generation Program ‐

1) Establishment of Self help groups

2) Rural Entrepreneurship Development Program

3) Handcrafts Development Program

4) Vocational Training

5) Business process outsourcing

C) Health, Education & Infrastructure

1) Aids Awareness Program

2) General Health Camps

3) Innovative Teaching Methods

4) Adult Education

5) Sanitation

6) Infrastructure Development Projects

7- 30

7.12 SOLVENT RECOVERY PLAN

NAME OF SOLVENT TOTAL

SOLVENT INPUT KG

QTY OF SOLVENT RECYCLED KG

QTY OF LOSSESKG

% RECOVERY % LOSS

Toluene 429.252 399.50 29.74 93.07 6.93 Methanol 305.241 287.38 17.85 94.15 5.84

Ethyl Acetate 1670.84 157.15 13.68 91.99 8.89 MDC 45.40 40.87 4.53 90.02 9.98

O‐Xylene 154.27 144.48 9.79 93.65 6.35 Methyl‐T‐Butyl Ether 5.95 5.32 0.62 89.54 10.46

IPA 94.01 89.92 5.09 94.64 5.36 Methylene Chloride 93.54 84.0 9.54 89.8 10.2

Hexane 18.83 7.44 1.38 92.65 7.35 Di‐Iso‐Propyl Ether 14.36 13.27 1.08 92.45 7.55

SOLVENT MANAGEMENT PLAN

• All the solvents shall be directly distilled from product mixes and; if required shall be purified in packed column with the help of reflux and therefore there is no generation of any distillation residue from the solvent distillation.

• The solvent distillation system shall be designed so as to achieve minimum 99.0 % recovery of solvent.

• Pure solvent, crude solvent and distilled (recovered) solvent shall be stored only in storage tanks and we shall not be using drums at any stage in the Solvent Management System.

• Wherever required, the solvents shall be directly pumped into day tanks from the storage tanks and shall be charged into the reactors without involving any manual handling.

• All the pumps shall be mechanical seal type to avoid any leakage of solvent.

• All necessary fire fighting systems shall be provided with alarm system. Flame proof wiring and flame proof electrical accessories shall be provided to avoid any mishap.

• All the storage tank and day tank shall be connected to a vent system through cooling water and chilled brine condensers to prevent loss of solvents in the atmosphere.

• All the distillation column vents are also connected to cooling water/ chilled brine condensers for maximum possible recovery of the solvents.

7- 31

• All the vents will be connected to a common carbon Adsorber for removing traces of solvent from vent gases.

• Residue generated from the distillation will be incinerated in‐house or sent to BEIL incinerator site.

• Coolant to be used

Primary Condensers Cooling Water

Secondary Condensers Chilled Brine up to ‐150C

Vent Condensers Chilled Brine up to ‐150C

Solvent Main

Storage Tank

Addition Tank

ReactionMass With

Solvent

ReceiverDistilled Solvent

Solvent Distillation

System

Recycle

Organic Layer/spent solvent to recovery

System

FLOW DIAGRAM OF SPENT SOLVENT MANAGEMENT SYSTEM

CHW i

CHB. In

C.W. Out

CHB. Out

For Alembic Pharmaceuticals Limited (Unit‐I)

CHB. Chilled Brine

CHW Chilled Water

Distillation Column

7- 32

7.13 METHODOLOGY OF DE‐CONTAMINATION AND DISPOSAL OF DISCARDED CONTAINERS AND ITS RECORD KEEPING

Decontamination & Disposal of Discarded Containers: The proper disposal of empty

chemical containers is more important for hazardous chemicals as it can contain residual

amounts of chemicals. There can be no more than 1 inch of material left in the container not

more than 3% by weight of the containers capacity. In an effort to ensure that this residue is

handled properly and to be able to recycle or properly dispose of these containers, the

following procedure is to be followed. The below guidelines are useful for non hazardous

chemicals also.

Rinse Procedure: An empty chemical container that contains hazardous chemicals (liquid or

solid), must be rinsed 3 times with water (or appropriate rinsing agent) before being

discarded. The first rinse should be collected as chemical waste, it can be put into any waste

container of compatible chemicals, the second & third rinses can then go down to drain. If

the chemical is on the list of acutely hazardous waste, then all three rinses must be

collected. For solvents or other volatile liquids like benzene, toluene, xylene etc. (not in the

list of acutely hazardous waste) should not be rinsed with water. They are to be placed into

an operating fume hood overnight without the cap to allow the vapors to disperse. After the

containers are rinsed, they can be discarded appropriately as described below. All caps

should be let off of the discarded containers. Containers should be labeled with “Empty”

labels and the chemical name should be crossed or blacked out prior to being discarded.

Caps may be discarded to regular trash.

Reuse /Recycle/ Disposal of cleaned containers:

• All chemicals must follow the above rinse except the volatile Solvents & before being

discarded in any form.

• Metal containers or any plastic containers, plastic tubing or plastic beakers that do not

meet the recycling criteria can be discarded into regular trash.

• Glass containers, glass tubing that do not meet the recycling criteria should be placed into

trash can for disposal.

7- 33

• Plastic & glass containers that meet the recycling criteria must be placed in appropriate

recycling containers.

• Empty compressed gas cylinders should be returned to vendor.

7.14 CAPITAL COST FOR ENVIRONMENTAL MANGEMENT

Total existing project cost is Rs. 34.41 Crores and cost for proposed project activity shall be

Rs. 36.81 Crores. Capital Cost of Air & Water Pollution Control System and Environmental

Monitoring Equipments will be Rs. 4.32 Crores.

7.15 COMPLIANCE TO THE RECOMMENDATIONS MENTIONED IN THE CREP GUIDELINES

Sr. No.

DESCRIPTION STATUS ACTION PLAN / REMARKS

1 Segregation of Waste stream

Implemented Segregation done by separate pipeline & collection tanks. Low COD stream is treated in existing ETP having primary & secondary treatment system. Then it is sent to R.O. for further treatment. Permeate water is used in Utility, Cooling Tower & reject of R.O. is fed to MEE. High COD stream are collected department wise and sent to solvent stripper after neutralization then to Multi Effect Evaporator System for concentrating the effluent. Distillate is reused in plant & Concentrate is fed to Incineration. Existing ETP Treatment facility are described in Chapter‐2.

2 Detoxification and treatment of high COD waste stream

Implemented High COD Stream first sent to Solvent stripper for solvent removal after that concentrate in Multi Effect Evaporator System and concentrate mass incinerated at in‐house incinerator.

3 Management of solid waste Implemented We have provided sufficient facility for handling and storage of hazardous waste. We have taken membership of common secured landfill site & Incineration of NECL, Nandesari and also taken membership for liquid waste incineration at SEPPL, Kutch. Following waste is generated & Disposal from our unit. Used/Spent Oil :‐‐ Sale to GPCB registered recycler Discarded containers:‐ Sale to GPCB registered scrape dealer Spent Solvent:‐ Recovered & reused Distillation Residue:‐ Recovered at recovery plant & concentrated in MEE. Residue & MEE concentrate mass is incinerated in our new incinerator or it will be sent to SEPPL, Kutch for incineration, if required. ETP Sludge:‐ Sent to NECL for disposal by secured landfilling. Process waste (Spent Carbon & Hyflo), filter Material:‐ Incinerated at our Incinerator Incinerator Ash :‐– Sent to NECL for secured landfilling

4 Minimum scale of production to afford cost of pollution control

Not Applicable

7- 34

5 Improvement in solvent recovery

Implemented Solvent Recovery should be improvement and attempts to be made for about 95%

6 Control of Air Pollution Implemented We have provided ammonia and HCL scrubber for control gaseous emission from process vent. Two additional scrubbers are being installed to process vent.

7 Self regulation by the industry through regular monitoring and environment of industry

Implemented We analyze the various parameter of effluent on daily basis. Third party sampling & analysis of effluent, stack and ambient air is carried out on monthly basis by external Party (Paramount Pollution). Environment Audit report for the year 2013 is submitted to GPCB, it was carried out by DDIT, Nadiad.

8 Organization restructuring and accreditation of environmental manager of industry

Implemented Environmental Management Cell is given as Figure‐7.1

9 Optimizing the inventory of hazardous chemical

Implemented Our industry is preparing production planning monthly basis. Hence, we are able to maintain minimum inventory of 30 days for Hazardous Materials.

10 Proper Operation of Incinerator

Implemented Incinerator installed and Operated as per CPCB Guidelines on regular basis.

8- 1

CHAPTER ‐ 8

EXECUTIVE SUMMARY


of

M/s. ALEMBIC PHARMACEUTICALS LIMITED

API UNIT‐I,

SURVEY NO.: 119, 120 & 121,

AT & POST: PANELAV, TAL: HALOL,

DIST: PANCHMAHAL‐389 350 (GUJ)

8- 2

8.1 Subject

M/s. Alembic Pharmaceuticals Limited (Unit‐I) proposes expansion of APIs in Existing

Unit at Survey No. 119, 120 & 121, At & Post: Panelav, Tehsil: Halol, Dist. Panchmahal,

Gujarat. Existing project cost is Rs. 34.41 Crores and cost for proposed project activity

shall be Rs. 36.81 Crores. Capital Cost of Air & Water Pollution Control System and

Environmental Monitoring Equipments will be Rs. 4.32 Crores. Total 68,530.26 m2 land

area is available at site; out of this 24,000 m2 (i.e. approx 35 % of total area) is

developed as greenbelt and other forms of greenery.

8.2 Product and Capacity

LIST OF PRODUCTS ALONG WITH THEIR PRODUCTION CAPACITY

Sr. No.

Product Existing (MT/Month)

Total after Proposed Expansion (MT/Month)

1 Clarithromycin 2 Azithromycin 3 Roxythromycin 4 Venlafaxine 5 Fenofibrate 6 Irbesartan 7 Valsartan 8 Telmisartan 9 Clonidine Hydrochloride 10 Modafinil 11 Leflunomide 12 Alendronate Sodium 13 O Desmethyl Venlafaxine 14 Meprobamate 15 Vildagliptin 16 Rivastigmine Tartrate 17 Topiramate 18 Lacosamide 19 Pramipexole Dihydrochloride Monohydrate 20 Olmesartan Medoxomil 21 Linezolid 22 Lercanidipine Hydrochloride 23 Fluxetine Hydrochloride 24 Deferasirox

25 75

8- 3

25 Ropinorole Hydrochloride 26 Hydrochlorothiazide 27 Lamotrigine 28 Metoprolol Tartrate 29 Metoprolol Succinate 30 Quetiapine Fumarate 31 Pentosan Polysulphate Sodium 32 Levetiracetam 33 Famotidine 34 Memantine HCl 35 Pregabalin 36 Ivabradine 37 Azilsartan 38 Etoricoxib 39 Derifenacin 40 Celecoxib 41 Rabeprazole Sodium 42 Clopidogrel Bisulfate 43 Felodipine 44 Prasugrel Hydrochloride 45 Mexiletine Hydrochloride 46 Warfarin 47 Bazedoxifene 48 Bosentan 49 Febuxostate 50 Dronedarone 51 Dabigatran 52 Rivaroxaban 53 Asenapine 54 Silosodine 55 Zolmitriptan 56 Iloperidone 57 Agomelatine 58 Ticagrelor 59 Metaxalon 60 Vilazodone Hydrochloride 61 Teriflunomide 62 Nisoldipine 63 Fesoterodine Fumarate 64 Minodronic acid 65 Erlotinib 66 Gefitinib

0

8- 4

8.3 Water Requirement, Waste Water Generation and Treatment:

Total fresh water requirement will be 160 m3/day which shall be met through own bore

well & 237.5 m3/day of Recycled Water i.e. 397.5 m3/day of total water consumption.

The wastewater generation will be 195 m3/day (Industrial) & Domestic wastewater of 50

m3/day shall be treated in ETP. Out of 245 m3/day Waste water generation, 237.5

m3/day Waste water is reused as it is RO permeate water, 5 m3/day is recovered Solvent

and 2.5 m3/day is MEE Concentrate.

8.4 Air Pollution Source and Control Management:

There will be emissions from Flue gas Stacks like Agro based Boiler 5 TPH, Boiler 1 & 2

(2 TPH), D.G.Set (750 KVA), Incinerator in Existing Scenario & Water Tube FBC Boiler 10

TPH, Thermic Fluid Heater in Proposed Scenario and emissions from Process Vents like

Reaction Vessels Pilot Plant, Reaction Vessels No‐1 in Plant‐1 (Replaced), Reaction

Vessels No‐2 in Plant‐1 (Replaced), Reaction Vessels in Plant‐2, Reaction Vessels in Plant‐

3, Reaction Vessels in Plant‐5, Reaction Vessels No‐2 in Plant‐2 in Existing Scenario &

Reaction Vessels No‐1 in Plant‐7, Reaction Vessels No‐2 in Plant‐7 in Proposed Scenario.

8.5 Hazardous Waste:

Hazardous waste generation will be Used Oil, Spent Solvent, Process Residue, Spent

carbon & Hyflow, Spent Mother Liquor, Discarded Drums, ETP Sludge, Filler & Filter

Material, Incinerator Ash, Off Specification Product / Date Expired Product, Fly Ash &

Evaporation Salt. All the Solid/Hazardous Waste generated will be disposed as per the

norms.

8.6 Green Belt:

Total 68,530.26 m2 land area is available at site; out of this 24,000 m2 (i.e. approx 35 %

of total area) is developed as greenbelt and other forms of greenery.

8- 5

8.7 Power & Fuel Requirements:

The power requirement is 38732 KWH/Day in Existing Scenario & it will be 54225

KWH/Day after proposed expansion. Company shall purchase power from MGVCL. Also

DG Set of 750 KVA (1 No. Existing & 1 No. Additional Proposed) will be provided for

emergency power backup.

Agro‐waste/ Briquettes: 1015 kg/hr, LDO: 195 Lit/Hr, HSD (As per requirement): 170

Lit/Hr are used as fuel in Existing Scenario. Agro‐waste/ Briquettes: 45 MT/Month,

Imported steam Coal: 1050 MT/Month, FO: 17.4 KL/Month, HSD: 0.75 KL/Month & LDO:

0.4 KL/Month will be used as fuel in Proposed Scenario.

8.8 Storage details of Hazardous Chemicals

Sr. No.

Tank No.

Name Of Solvent UOM Solvent Yard

Storage Capacity (KL)

1 ST005 Toluene (Fresh) Ltrs 22 2 ST006 Absolute Ethyl Alcohol with 0.5% Acetone Ltrs 22 3 ST007 Methanol (Fresh) Ltrs 30 4 ST008 Acetone Ltrs 22 5 ST009 Iso Propyl Alcohol ( Fresh) Ltrs 22 6 ST010 Ethyl Acetate (Fresh) Ltrs 22 7 ST014 Absolute Ethyl Alcohol with 3% Cyclohexane( Fresh) Ltrs 26 8 ST015 Absolute Ethyl Alcohol with 3% Cyclohexane(Recovered) Ltrs 26 9 ST016 Iso Propyl Alcohol (Recovered) Ltrs 33

10 ST017 Methanol (Fresh) Ltrs 20 11 ST018 Toluene Ltrs 20 12 ST019 Acetone (Fresh) Ltrs 20 13 ST020 Acetone (Crude) Ltrs 20 14 ST004 HCl Ltrs 15 15 ST001 Sulfuric Acid Ltrs 10 16 ST002 Liquor Ammonia Ltrs 15

8.9 Capital and recurring cost earmarked for environmental protection measures:

Existing Project Cost is Rs. 34.41 Crores and Cost for Proposed project activity is Rs.

36.81 Crores. Cost of EMS is 4.32 Crores (Proposed Scenario).

8- 6

8.10 Baseline Environmental Status

Air Environment

The dispersion of pollutants in the atmosphere is a function of several meteorological

parameters viz. temperature, wind speed and direction, mixing depths, inversion level,

etc. The ambient air samples were collected and analyzed for Particulate Matter (PM10),

Particulate Matter (PM2.5), Sulphur Dioxide (SO2), Oxides of Nitrogen (NOx), Ozone (O3),

Lead (Pb), Carbon Monoxide (CO), Ammonia (NH3), Benzene (C6H6), Benzo (a) Pyrene

(BaP), Arsenic (AS), Nickel (Ni), HCl, Cl, HC, HF & VOCs were monitored at site and

nearby villages for identification, prediction, evaluation and assessment of potential

impact on ambient air environment.

The PM10 values at all the locations in residential/rural areas ranged between 75.53 –

89.26 µg/m3 in post‐monsoon season. Similarly, the values of PM2.5 varied in the range

of 39.68 – 45.48 µg/m3. The PM10 and PM2.5 concentrations at all the AAQM locations

were primarily caused by local phenomena including vehicular activities and natural

dust getting air borne due to manmade activities and blowing wind. The values of NOx at

all the locations in residential/rural areas were observed to be in the range of 11.52 –

15.37 µg/m3. The values of SO2 at all the locations in residential/rural areas ranged

between 10.49 – 14.25 µg/m3. The values of O3 at all the locations in residential/rural

areas ranged between 10.41 – 12.16 µg/m3. At all the air quality monitoring locations in

residential/rural areas, the values of NOx, SO2 & O3 were observed to be within limits.

The values of CO at all the locations in residential/rural areas ranged between BDL –

1.18 mg/m3. The values of NH3 at all the locations in residential/rural areas ranged

between 2.11 – 4.64 µg/m3. The values of VOCs at all the locations in residential/rural

areas ranged between 0.4 – 1.3 ppm. At all the AAQM locations (Industrial as well as

residential) Pb, C6H6, BaP, As, Ni, HC, HF, HCl and Cl values were below detectable limit.

8- 7

Baseline Ground Water Quality

pH of ground water samples varies from 7.06 – 7.6. Turbidity, Total Dissolved Solids and

Total Suspended Solids varies in the range of 0.2 – 0.3 NTU, 346 ‐ 1080 mg/L and 20 ‐ 30

mg/L respectively. Nitrate Nitrogen and Total Phosphorus are found in the range of 3.13

– 11.2 mg/L and BDL respectively. DO is found in range of 5.12 – 6.72 mg/L. COD, BOD3

are found in the range of 2.64 – 10.6 mg/L and <1 mg/L respectively. Total hardness (as

CaCO3) varies from 264 – 844 mg/L. Calcium hardness (as CaCO3) varies from 138 – 460

mg/L. Total Alkalinity varied from 157.5 – 297.5 mg/L. Chlorides and Sulfates are found

in the range of 14.9 – 409.5 mg/L and 14.9 – 65.1 mg/L respectively. Copper is not found

in any sample. Sodium, Potassium are found in the ranges 22.3 ‐ 80 mg/L, 1.4 – 32.8

mg/L respectively. Nickel & Arsenic are not found in any sample.

Baseline Surface Water Quality

pH of surface water sample varies from 7.45 – 7.73. Turbidity, Total Dissolved Solids and

Total Suspended Solids are in the range of 0.2 NTU, 154 ‐ 400 mg/L and 22 ‐ 24 mg/L

respectively. Nitrate Nitrogen and Total Phosphorus are found in the range of 1.72 –

2.87 mg/L and BDL respectively. DO and COD are found in range of 6.94 – 7.08 mg/L and

6.61 – 18.5 mg/L respectively. BOD3 and Total hardness (as CaCO3) varies from <1 mg/L

and 138 – 292 mg/L respectively. Calcium hardness (as CaCO3) varies from 86 – 136

mg/L. Total Alkalinity varies from 77 ‐ 84 mg/L. Chlorides and Sulfates are found in the

range of 12.4 – 124.1 mg/L and 23.5 – 34.8 mg/L respectively. Copper, Zinc, Cadmium,

Nickel & Arsenic are not found in the sample. Sodium, Potassium are found in the

ranges 11.2 – 20.6 mg/L and 1.4 – 5 mg/L respectively.

Baseline Soil Status

pH varies from 7.08 – 8.42. Water Holding Capacity (WHC) varies from 32.26 % ‐ 47.99

%. Bulk Density varies from 1.05 – 1.37 g/cm3. Sulphates and Chlorides are found in the

range 110.5 – 886.7 mg/kg and 496.3 – 794 mg/Kg respectively. Total Hardness varies

from 876.2 – 2577.2 mg/kg. Calcium and Sodium are found in the range of 227 – 763.7

8- 8

mg/kg and 888 ‐ 2452 mg/kg respectively. Iron varies from 6.23 – 118.6 mg/kg.

Potassium is found in the range 1802 – 3134 mg/kg. Copper is not found in any sample.

Environmental Hazard

The project proponent shall consider all the safety aspects in planning, designing and

operation of the project as per standard practices. Hence, no adverse impact on this

account is anticipated. Adequate pollution control measures will be taken to check any

kind of contamination or pollution from the company. Considering the pollution control

measures taken by the company environment management system adopted there is no

significant adverse impact on environment.

Cumulative Impact Chart

ENVIRONMENTAL

PARAMETER

TOTAL CUMULATIVE

SCORE

Air Quality 14

Noise and Odour 11

Water Quality 7

Land Requirement 8

Infrastructure 11

Service 12

Environmental Hazards 10

Housing 2

Terrestrial Ecology/ Land use 11

Socio Economic Status 7

Aquatic Ecology 1

8- 9

8.11 Conclusion

It can be concluded that the proposed expansion project is beneficial in the interest of

common man, the society, the state and as the country as a whole. The benefits can be

summarized as below:

The proposed expansion project will provide quality product at lower cost to the

users.

There should be positive impact on the socio‐economic condition of the area in

terms of direct and indirect employment due to the proposed expansion project.

Numbers of local trained persons are likely to get jobs.

Country will save valuable foreign exchange as import of these products will be

reduced by corresponding amount.

These products also have export potential. Hence, possibility of earning foreign

exchange.

M/S. AQUA – AIR ENVIRONMENTAL ENGINEERS PVT. LTD. 403, CENTER POINT, NR. KADIWALA SCHOOL, RING ROAD, SURAT – 395002 (GUJARAT)

TEL: +91 (261) 2460854/2461241/3987173/3048586 TELEFAX: +91 (261) 2707273/3987273 EMAIL: [email protected] WEBSITE: WWW.AQUA‐AIR.CO.IN

1

CHAPTER ‐ 9 DISCLOSURE OF CONSULTANTS ENGAGED

Aqua‐Air Environmental Engineers Pvt. Ltd.

(Pollution Control Consultants & Engineers)





2

COMPANY PROFILE

Aqua‐Air Environmental Engineers Pvt. Ltd. is a Surat based company; one of the leading and

multidiscipline Environmental Management Consulting firms of the region.

Aqua‐Air Environmental Engineers Pvt. Ltd. was founded by Mr. Jayesh S. Patel & Mrs. Archana J. Patel

on May 7, 2008 and Aqua‐Air Environmental Engineers Pvt. Ltd. was registered under the companies

Act on May 7, 2008.

Office having 3756 Sq. Ft. of area covering EC/EIA Department, R & D Centre (Environmental

Laboratory), Consent (NOC/CC&A) Department, ETP/Civil Department and Account Department,

Library, Conference room and Administration Department, etc. with experienced and qualified staff to

render services in the field of Environmental Management of various types of industries.

Aqua‐Air Environmental Engineers Pvt. Ltd. has a well‐established track record in monitoring legislation

and developing and implementing strategies for organizations that enable them to manage the impact

of environmental issues on their business.

The company has built a reputation for delivering innovative and practical solutions to environment

related business issues. These solutions help our clients to achieve successful business outcomes and

make sustainable environment serving improvements within their business operations.

Aqua‐Air Environmental Engineers Pvt. Ltd. started the process for ISO/IEC 17025:2005 Accrediation by

NABL, New Delhi for the Competence Testing & Calibration Laboratories on June 24, 2008 and

submitted the application (Version No. 10) to NABL, New Delhi for ISO/IEC 17025:2005 registration on

October 7, 2008. After final assessment and Non‐Conformances resolved and corrective actions taken

against the Non‐Conformances, Laboratory Department ‐ Aqua‐Air Environmental Engineers Pvt. Ltd.

was accredited with the certification of ISO/IEC 17025:2005 on October 19, 2010.

Aqua‐Air Environmental Engineers Pvt. Ltd. started the process for ISO 9001:2008 registration for

Quality Management System on December 1, 2009 and submitted the application for ISO 9001:2008



3

registration on March 4, 2010. After final assessment, Aqua‐Air Environmental Engineers Pvt. Ltd. was

certified from ANAB by M/s. Intertek System Certification on May 4, 2010.

Aqua‐Air Environmental Engineers Pvt. Ltd. started the process for “EIA Consultant Organization”

accreditation under National Accreditation Board for Education And Training (NABET)/Quality Council

of India (QCI), New Delhi on January 7, 2010 and submitted the application (Rev. 06) for “EIA

Consultant Organization” accreditation under NABET, New Delhi on April 8, 2010. Office assessment

was done by external NABET/QCI auditors on 3/2/2011 to 4/2/2011. NABET/QCI closed the application

of Aqua‐Air Environmental Engineers Pvt. Ltd. on March 15, 2011. Aqua‐Air Environmental Engineers

Pvt. Ltd. filed SCA in Hon’ble High Court of Gujarat against MoEF, QCI & NABET, New Delhi on April 13,

2012. Hon’ble High Court of Gujarat issued stay order against operation of all OMs (related to

NABET/QCI Scheme) of MoEF, New Delhi for the company on Jan. 24, 2013.

Aqua‐Air Environmental Engineers Pvt. Ltd. received the Certificate of Registration of Trade Mark,

Section 23 (2), Rule 62 (1) from Trade Marks Registry, Govt. of India on January 18, 2011.

The company’s work is spread over all the region of Gujarat in India. Company have already conducted

EIA studies and EIA / EMP reports prepared for more than 180 units that includes Water related

Projects / Pesticide Industry Projects / Textile Industry Projects / Sugar Industry Projects / Chemical

Industries / Chemical Fertilizer Industry Projects / Cement Plants / Thermal Power Plants / Mining

Projects / Infrastructure Projects / Construction Projects / Distilleries / Petrochemical Industry

Projects/ SEZ Project/ CRZ Project etc.

Company's NABL Accredited Testing Laboratory has conducted Environmental Monitoring & Analysis

with Environmental Institute and Gujarat Pollution Control Board in Industrial Estates of Ankleshwar,

Panoli & Jhagadia. Company is also doing Turnkey/Consulting Projects for M/s. BASF (Detail

Engineering for Effluent Treatment Plant) & M/s. Reva Proteins Ltd. (Design of Effluent Treatment

Plant, supply of mechanical items, Commissioning and operation of Effluent Treatment Plant).



4

2. ABOUT US

Aqua‐Air Environmental Engineers Pvt. Ltd. has registered office in one of the top five fastest growing

cities of India – Surat. We are one of the most trusted and reliable environmental and engineering

consultancy service providers. With complete hold in the related domain and proficiency, we execute

our work all over Gujarat region.

In addition to engineering consultancy, we also execute turnkey projects for effluent treatment plants

at the client's site.

Aqua‐Air Environmental Engineers Pvt. Ltd is: • One of the leading companies in the region providing high quality services in environmental

engineering to the best of client's satisfaction.

• Posses a well ‐ developed design office with Computer Center and Laboratory ‐cum‐ R&D Center to

carry out designing and analysis in the field of environmental engineering.

• Recognized as Schedule‐II Environmental Auditor under the Environment Audit Scheme proposed

by the Hon'ble High Court of Gujarat.

• Listed with Gujarat Pollution Control Board as Consultants and proposing to get enlisted with GPCB

as Pollution Control Equipment Suppliers.

• Going to become a member of Consulting Engineers Association of India.

• Having well‐developed library to render services in the field of environmental auditing, consulting,

monitoring and analysis.

3. ACHIEVEMENTS

1. Registered under the companies Act on May 7, 2008.

2. Gujarat Pollution Control Board Recognized Schedule – II Environmental Auditor on Dec. 24,

2008.

3. Certificate of ISO 9001:2008 received on May 4, 2010.

4. Import Export Licence received from Government of India on May 31, 2010.

5. Solvency Certificate of Rs. 1,40,00,000/‐ received from Bank of India, Gopipura branch, Surat on

Sept. 3, 2010.



5

6. Certificate of National Accreditation Board for Testing and Calibration Laboratories (NABL)

received on Oct. 15, 2010.

7. Certificate of Registration of Trade Mark, Section 23 (2), Rule 62 (1) from Trade Marks Registry,

Govt. of India on Jan. 18, 2011.

8. Certificate of Authorization as dealer in India received from Spectrum Technologies, Inc., USA

on May 1, 2011.

9. Gujarat Pollution Control Board Recognized Schedule – II Environmental Auditor on May 6,

2011.

4. SERVICE PROVIDE

M/s. AQUA‐AIR ENVIRONMENTAL ENGINEERS PVT. LTD. offers following specialized services in

Environmental Engineering, Water Supply Engineering and Civil Engineering.

4.1 TURN KEY/BOOT/BOO PROJECTS

4.1.1 ENVIRONMENTAL ENGINEERING

Detailed design Water Treatment Plants (WTPs) Construction Common Effluent Treatment Plants (CETPs) Fabrication Recycling Plants (RPs) Piping Zero Discharge Plants (ZDPs) Electrification Incineration System Plants (ISPs) Supply Hazardous waste Storage areas (HWSAs) Erection Secured/ Sanitary Landfill Facilities Testing and Commissioning of Effluent Treatment Plants (ETPs)

Bio–Medical Waste (BMW) Treatment Facilities on a turnkey or BOOT/BOO basis.

Sewage Treatment Plants (STPs)

4.1.2 CIVIL ENGINEERING Construction of

Water Treatment Plan Elevated Service Reservoirs (ESRs) Sewage Treatment plant Underground Reservoirs (UGRs) Industrial Wastewater Treatment plant Sewage Pumping Stations, etc.



6

4.2 CONSULTING 4.2.1 ENVIRONMENTAL ENGINEERING 1. Complete study of the Pollution Problem in industries from wastes generation to disposal and

providing necessary technical knowledge like– How including design Zero Discharge Plants (ZDPs) Basic engineering, detailed engineering Water Treatment Plants (WTPs)

Recycling plants (RPs) for reuse of water upto maximum extent

Tender preparation for Effluent Treatment Plants (ETPs) for industrial wastewater

Incineration System Plants (ISPs) for various non‐biodegradable or toxic industrial wastes on Consulting basis

Sewage Treatment Plants (STPs) for residential wastewater

Design of Hazardous waste Storage area and Consultancy Services for Secured/ Sanitary Landfill Facilities

Common Effluent Treatment Plants (CETPs) for more than two industries

Design and Consultancy Services for Bio – Medical Waste Treatment Facilities.

2. Water Supply Distribution System

Analysis Tender preparation Design

3. Laboratory Analysis of

Air Waste Water Water Industrial Effluent Sewage Industrial Sludge

4. Process Study

Reduce the pollution at source Reuse / Recycle effluent

5. Pollution Control Facility Performance study of existing Suggesting scheme for the optimization of the

facility

6. Environment Management Environmental Clearance from Environmental Impact Assessment Studies (EIAs)

• MoEF • Short term (Rapid) • New Delhi or DoEF • Long term (Comprehensive) • Gandhinagar

Environmental statements Environmental Auditing

7. Statutory Requirements under Factory Act Safety Audit On‐site / Off‐site Emergency Plan

HAZOP study

8. For Various Energy Conservation Schemes

Energy Audit Design



7

9. Environmental Management System Preparing Adequacy Report Preparing Efficacy Report

10. Operation and Maintenance (O & M)

Effluent Treatment Plants (ETPs) Water Treatment Plants (WTPs) Sewage Treatment Plants (STPs)

11. Air Monitoring

Ambient Air Stack Vent

12. Design of Pollution Control Equipment

Cyclone Flash mixers Scrubbers Reaction Vessels Bag Filters, fume extraction systems Clariflocculators Blowers Scrapper Mechanisms Aerators Incinerators Agitators Scrubbers, etc.

13. Pollution Control Effluent Survey Feasibility Studies

Laboratory bench scale Treatability studies Environmental review of Pollution control equipment and systems Pilot Plant studies etc.

14. Consulting Service

NOC Air Consent Water Consent Hazardous Waste Authorization Application, etc.

15. As per requirements under Factory Act‐1948 and Gujarat Factory Rules

Monitoring filling up Form‐37 Analysis of Work Area Environment

16. Technical Consultation & assistance to ensure and assure compete Environ‐Legal compliance

Clearance Liaison with statutory bodies in order to get the required permits Consents

4.3 EQUIPMENT MFG. /TRADING

4.3.1 ENVIRONMENTAL ENGINEERING 1. Manufacture and supply of Pollution Control Equipment such as

Incinerators With scrubbers Dissolved Air Flotation (DAF) units Autoclaves Cyclone Hydro‐claves Scrubbers Fixed Aerators Bag Filters Floating Aerators Oil Skimmers Submersible Aerators (EOLO2) Deoiler Pipes Submersible Mixers (RIO or BRIO) API separators



8

Cascade Aerators Vacuum Drum filters Clarifier mechanisms Solid bowl centrifuges Agitators Filter presses Clariflocculator Belt filters Clariflocculator mechanism Reaction vessels Flash mixes Reverse Osmosis, etc. Oil skimmers

A- 1

LIST OF ANNEXURES

ANNEXURE

NO.

TITLE

1 National ambient air quality standards

2 Damage risk criteria for hearing loss occupational safety & health administration (OSHA)

3 CPCB recommendations for community noise exposure

4 CPCB standards classification of inland surface water

5 Indian standards: specifications for drinking water

6 Indian standards for industrial and sewage effluents discharge

7 Application for ground water withdrawal permission from CGWA

8 Copy of Acceptance letter for fly ash for brick manufacturing & Memorandum of

Understanding signed with cement manufacturer for co-processing of organic waste &

Copy of Coal Supply Letter

9 Membership certificates from Common Environmental Infrastructure facilities (TSDF &

CHWIF)

10 Copy of Certified Report by RO, MoEF & its Compliance

11 Public Hearing Minutes

12 Copy of Material Safety Data Sheets

13 Copy of Hon'ble High Court’s Stay Order & Extensions

A- 2

ANNEXURE - 1

NATIONAL AMBIENT AIR QUALITY STANDARDS (NAAQS) (2009)

Concentration in Ambient Air Sr.

No.

Pollutant Time

Weighted

Average

Industrial

Residential,

Rural and

Other Area

Ecologically

Sensitive Area

(notified by

Central

Government)

Methods of

Measurement

(1) (2) (3) (4) (5) (6)

1 Sulphur Dioxide

(SO2), µg/m3

Annual*

24 Hours**

50

80

20

80

• Improved West and

Geake

• Ultraviolet

fluorescence

2 Nitrogen Dioxide

(NOx), µg/m3

Annual*

24 Hours**

40

80

30

80

• Modified Jacob &

Hochheiser (Na-

Aresenite)

• Chemiluminescence

3 Particular Matter

(size less than 10

µm) or PM10 µg/m3

Annual*

24 Hours**

60

100

60

100

• Gravimetric

• TOEM

• Beta attenuation

4 Particular Matter

(size less than 2.5

µm) or PM2.5 µg/m3

Annual*

24 Hours**

40

60

40

60

• Gravimetric

• TOEM

• Beta attenuation

5 Ozone (O2) µg/m3 8 Hours**

1 Hour**

100

180

100

180

• UV photometric


• Chemical Method

6 Lead (Pb) µg/m3 Annual*

24 Hours**

0.50

1.0

0.50

1.0

• AAS/ICP method

after sampling on

EPM 2000 or

equivalent filter

paper

• ED-XRF using Teflon

filter

7 Carbon Monoxide

(CO) mg/m3

8 Hours**

1 Hour**

02

04

02

04

• Non Dispersive Infra

Red (NDIR)

Spectrology

8 Ammonia (NH3)

µg/m3

Annual*

24 Hours**

100

400

100

400


• Indophenol blue

method

A- 3

* Annual arithmetic mean of minimum 104 measurements in a year at a particular site taken twice a

week 24 hours at uniform intervals

** 24 hourly or 08 hourly or 01 hourly monitored values, as applicable, shall be complied with 98%

of the time in a year. 2% of the time, they may exceed he limits but not on two consecutive days

of monitoring.

Note: Whenever and wherever monitoring results on two consecutive days of monitoring exceed the

limits specified above for the respective category, it shall be considered adequate reason to

institute regular or continuous monitoring and further investigation.

Concentration in Ambient Air Sr.

No.

Pollutant Time

Weighted

Average

Industrial

Residential,

Rural and

Other Area

Ecologically

Sensitive Area

(notified by

Central

Government)

Methods of

Measurement

(1) (2) (3) (4) (5) (6)

9 Benzene (C6H6)

µg/m3

Annual* 05 05 • Gas chromatography

based continuous

analyzer

• Absorption and

Desorption followed

by GC analysis

10 Benzo (a) Pyrene

(BaP) particulate

phase only, mg/m3

Annual* 01 01 • Solvent extraction

followed by HPCL/GC

analysis

11 Arsenic (AS),

mg/m3

Annual* 06 06 • AAS/ICP method

after sampling on

EPM 2000 or

equivalent filter

paper

12 Nickel (Ni), mg/m3 Annual* 20 20 • AAS/ICP method

after sampling on

EPM 2000 or

equivalent filter

paper

A- 4

ANNEXURE - 2

________________________________________________________________________

DAMAGE RISK CRITERIA FOR HEARING LOSS

OCCUPATIONAL SAFETY& HEALTH ADMINISTRATION (OSHA)

MAXIMUM ALLOWABLE

DURATION PER DAY

(HOURS)

NOISE LEVEL

(SLOW RESPONSE)

dB(A)

8 90

6 92

4 95

3 97

2 100

1.5 102

1 105

0.5 110

0.25 or Less 115

A- 5

ANNEXURE - 3

________________________________________________________________________

CPCB RECOMMENDATIONS FOR COMMUNITY NOISE EXPOSURE (1989)

CATEGORY

OF AREA

Leq (dBA)

(DAYTIME)

(06:00 TO 21:00 HRS)

Ldn (dBA)

(NIGHT TIME)

(21:00 TO 06:00 HRS)

Industrial Area 75 70

Commercial Area 65 55

Residential Area 55 45

Silence Zone 50 40

Note:

1. Day time shall mean from 6.00 a.m. to 10.00 p.m.

2. Night time shall mean from 10.00 p.m. to 6.00 a.m.

3. Silence zone is an area comprising not less than 100 meters around hospitals, educational

institutions, courts, religious places or any other area which is declared as such by

competent authority.

4. Mixed categories of areas may be declared as one of the four above mentioned

categories by the competent authority.

*dB(A) Leq denotes the time weighted average of the level of sound in decibels on scale A

which is relatable to human hearing.

A "decibel" is a unit in which noise is measured.

"A", in dB(A) Leq, denotes the frequency weighting in the measurement of noise and

corresponds to frequency response characteristics of the human ear.

Leq: It is energy mean of the noise level, over a specified period.

A- 6

ANNEXURE - 4 __________________________________________________________________________________________

CLASSIFICATION OF INLAND SURFACE WATER (CPCB STANDARDS)

SR

NO.

CHARACTERISTICS A@ B@ C@ D@ E@

1 Dissolved Oxygen

(mg/L), Min

6 5 4 4 -

2 Biochemical Oxygen

Demand (mg/L), Min

2 3 3 - -

3 Total Coliform

Organisms,

MPN/100 ml, Max.

50 500 5000 - -

4 Total Dissolved Solids

(mg/L), Max

500 - 1500 - 2100

5 Chlorides (as Cl-), mg/L,

Max.

250 - 600 - 600

6 Colour,

Hazen units, Max

10 300 300 - -

7 Sodium absorption

ratio, Max

- - - - 26

8 Boron (as B), mg/L, Max - - - - 2

9 Sulphates (as SO4-2

),

mg/L, Max.

400 - 400 - 1000

10 Nitrates (as NO3-), mg/L,

Max

20 - 50 - -

11 Free Ammonia

(as N), mg/L, Max

- - - 1.2 -

12 Conductivity at 25°C,

micromhos/cm, Max

- - - 1.0 2.25

13 pH value

6.5-8.5 6.5-8.5 6.5-8.5 6.5-8.5 6.0-8.0

14. Arsenic (as As), mg/L,

Max

0.05 0.2 0.2 - -

15 Iron (as Fe), mg/L, Max 0.3 - 50 - -

16 Fluorides (as F), mg/L,

Max

1.5 1.5 1.5 - -

17 Lead (as Pb), mg/L,

Max

0.1 - 0.1 - -

18 Copper (as Cu), mg/L,

Max

1.5 - 1.5 - -

19 Zinc (as Zn), mg/L,

Max

15 - 15 - -

*: If the Coliform count is found to be more than the prescribed tolerance limits, the criteria

for coliforms shall be satisfied if not more than 20 percent of samples show more than the

tolerance limits specified, and not more than 5 percent of samples show values more than 4

times the tolerance limit. Further, the feacal coliform should not be more than 20 percent of

the coliform.

A- 7

ANNEXURE - 5

___________________________________________________________________________

INDIAN STANDARDS/SPECIFICATIONS FOR DRIINKING WATER IS: 10500-1991

SR

NO.

SUBSTANCES OR

CHARCTER-

ISTICS

MAX

REQUIREME-

NT

(DESIRABLE

LIMIT)

UNDESIRABLE

EFFECTS OUT-SIDE

THE DESIRABLE

LIMIT

PERMISSIBLE

LIMIT IN

ABSENCE OF

ALTERNATE

SOURCE

METHOD

OF TEST

CI REF OF

IS: 3025

REMARKS

ESSENTIAL CHARACTERISTICS

1 Colour, Hazen

unit

5 Above this,

consumer

acceptance

decreases

25 4 of 3025,

1983

Extended upto 25

only if toxic

substances are not

suspected in

absence of

alternate

Source.

2 Odour Unobjectionable - 5 of

3025,198

3

a. Test cold and

when heated

b. Test at several

dilutions

3 Taste Agreeable - - Test to be

conducted only

after safety has

been established

4 Turbidity, NTU 5 Above this,

consumer

acceptance

decreases

10 8 Test to be

conducted only

after safety has

been established

5 pH Value 6.5-8.5 Beyond this range

the water will affect

the mucous

membrane and/or

water supply

system

No relaxation 8 -

6 Total Hardness

mg/L (as CaCO3)

300 Encrustation on

water supply

structure and

adverse effects on

domestic use

600 - -

7 Iron (as Fe), mg/L 0.3 Beyond this limit,,

taste/appearance

are affected has

adverse effect on

domestic uses and

water supply

structures &

promotes iron

bacteria

1.0 32 of

3025,

1964

-

8 Chlorides

(as Cl-) mg/L

250 Beyond this limit

taste, corrosion and

palatability are

affected

1000 32 of

3025

-

9 Residual free

chlorine, mg/L

0.2 - - 26 of

3025,

1986

To be applicable

only when water is

chlorinated tested

at consumer end,

when protection

against viral

infection is required

it should be min 0.5

mg/L

A- 8

ANNEXURE – 5 (Contd.) DESIRABLE CHARACTERISTICS

10 Dissolved Solids,

mg/L

500 Beyond this

palatability

decrease and may

cause

gastrointestinal

irritation

2000 16 of

3025

11 Calcium (as Ca)

mg/L

75 - 200 40 of

3025,

1984

12 Copper (as Cu),

mg/L

0.05 Astringent, taste

discoloration of

pipes, fittings and

utensils will be

caused beyond this

1.5 36 of

3025,

1964

13 Manganese (as

Mn), mg/L

0.1 Astringent, taste

discoloration of

pipes, fittings and

utensils will be

caused beyond this

0.3 35 of

3025,196

4

14 Sulphate (as SO4-

2), mg/L

200 Beyond this causes

gastrointestinal

irritation when

magnesium or

sodium are present

400 24 of

3025,

1986

May be

extended upto

400 provided

(as Mg) does

not exceed 30

mg/l

15 Nitrate (as NO3-),

mg/L

45 Beyond this

methaemoglo-

binemia

100 - -

16 Fluoride (as F-),

mg/L

1.0 Fluoride may be

kept as low as

possible. High

fluoride may cause

fluorosis

1. 5 23 of

3025,

1964

-

17 Phenolic

substances mg/L

(as C6H5OH)

0.001 Beyond this, it may

cause objectionable

taste and odour

0.002 54 of

3025

18 Mercury (as Hg),

mg/L

0.01 Beyond this, the

water becomes

toxic

No relaxation See note

mercury

ion

analyzer

To be tested

when pollution

is suspected

19 Cadmium (as Cd),

mg/L

0.01 Beyond this the

water becomes

toxic


mercury

ion

analyser

To be tested

when pollution

is suspected

20 Selenium (as Se)

mg/L


water becomes

toxic

No relaxation 28 of

3025,

1964

To be tested

when pollution

is suspected

21 Arsenic (As),

mg/L


water becomes

toxic

No relaxation 37 of

3025,

1988

To be tested

when pollution

is suspected

22 Cyanide (CN-),

mg/L


water becomes

toxic

No relaxation 27 of

3025,

1986

To be tested

when pollution

is suspected

23 Lead (Pb), mg/L 0.05 Beyond this the

water becomes

toxic


86

To be tested

when pollution

plumb

solvency is

suspected

A- 9

ANNEXURE – 5 (Contd.)

24 Zinc (as Zn), mg/L 5 Beyond this limit it

can cause

astringent taste and

an opalescence in

water

15 39 of

3025,196

4

To be

tested

when

pollution

is

suspected

25 Anionic

detergents mg/L

(as MBAS)

0.2 Beyond this limit

undesirable taste

and odour after

Chlorination takes

place

1.0 Methylen

e blue

extraction

method

To be

tested

when

pollution

is

suspected

26 Chromium (as

Cr+6

), mg/L

0.01 May be

carcinogenic above

this limit

0.05 28 0f

3025

To be

tested

when

pollution

is

suspected

27 Polynuclear

aromatic

hydrocarbons,

mg/L

- May be

carcinogenic

- 28 of

3025,196

4

To be

tested

when

pollution

is

suspected

28 Mineral Oil, mg/L 0.01 Beyond this limit

undesirable taste

and odour after

Chlorination takes

place

0.03 Gas

chromato

graphic

method

To be

tested

when

pollution

is

suspected

29 Pesticides

mg/L

Absent Toxic 0.001 58 of

3025,

1964

-

30 Radioactive

materials

a. Alpha emitters

Bq/L

b. Beta emitters

pci/L

-

-

-

-

0.1

1.0

-

-

-

-

31 Alkalinity (as

CaCO3), mg/L

200 Beyond this limit

taste becomes

unpleasant

600 13 of

3025,196

4

-

32 Aluminum (as Al),

mg/L

0.03 Cumulative effect is

reported to cause

dementia

0.2 31 0f

3025,196

4

-

33 Boron (as B),

mg/L

1 - 5 29 of

3025,196

4

-

Note: Atomic absorption spectrophotometric method may be used.

A- 10

ANNEXURE - 6

________________________________________________________________________

INDIAN STANDARDS FOR INDUSTRIAL AND SEWAGE EFFLUENTS DISCHARGE IS: 2490-1982

INDUSTRIAL EFFLUENT SR

NO.

PARAMETERS

INTO INLAND

SURFACE

WATER

ON LAND FOR

IRRIGATION

INTO

MARINE

COASTAL

AREA

INTO PUBLIC

SEWERS

1 Colour / odour - - - -

2 Suspended Solids

(mg/L)

100 200 100(for

Process

Waste)

600

3 Particle Size

Suspended Solids

Shall pass

850 micron IS

sieve

- Floatable

Solids Max 3

mm

Settable

Solids

Max 850

micron

-

4 Dissolved Solids

(Inorganic),

mg/L

2100 2100 - 2100

5 pH Value 5.5-9.0 5.5-9.0 5.5-9.0 5.5-9.0

6 Temperature °C Shall not

exceed 40 in

any section

of the stream

within 15

mts. down

stream from

the effluent

outlet

- 45 at the

point of

discharge

-

7 Oil & Grease, mg/L,

Max.

10 10 20 20

8 Total Residual

Chlorine, mg/L, Max

1 - 1 -

9 Ammonical

Nitrogen (as N) mg/L

max

50 - 50 50

10 Total Kjeldahl

Nitrogen (as N), mg/L,

Max

100 - 100 -

11 Free Ammonia (as

NH3) mg/L, Max.

5 - 5 -

12 Biochemical Oxygen

Demand,

5 Days at 20 ° C

30 100 100 350

13 Chemical Oxygen

Demand, mg/L, Max.

250 - 250 -

14 Arsenic (as As), mg/L,

Max.

0.2 0.2 0.2 0.2

A- 11

ANNEXURE – 6 (Contd.)

15 Mercury (as Hg)

mg/L

0.01 - 0.01 0.01

16 Lead (as Pb), mg/L,

Max

0.1 - 1.0 1.0

17 Cadmium (as Cd),

mg/L, Max

2 - 2 1

18 Hexavalent Chromium

(As Cr+6

), mg/L, Max.

0.1 - 1 2

19 Total Chromium (as

Cr) mg/L, Max

2 - 2 2

20 Copper (as Cu), mg/L,

Max

3 - 3 3

21 Zinc (as Zn), mg/L,

Max.

5 - 15 15

22 Selenium (as Se),

mg/L, Max

0.05 - 0.05 0.05

23 Nickel (as Ni), mg/L,

Max

3 - 5 3

24 Boron (as B), mg/L,

Max

2 2 - 2

25 Percent Sodium, Max - 60 60 -

26 Residual Sodium

Carbonate, mg/L,

Max

- 50 - -

27 Cyanide (as CN-),

mg/L, Max

0.2 0.2 0.2 0.2

28 Chloride (as Cl-), mg/L,

Max

1000 600 - 1000

29 Fluoride (as F-) mg/L,

Max

2 - 15 15

30 Dissolved Phosphate

(as P), mg/L, Max

5 - - -

31 Sulphate (as SO4-2

)

mg/L, Max

1000 1000 - 1000

32 Sulphide (as S-2

) mg/l,

Max

2 - 5 -

33 Phenolic Compounds

(as C6H5OH) Max

1 - 5 6

34 Radioactive materials

a.) Alpha emitters

µc/mL, Max

b.) Beta emitters

µc/mL, Max

10-7

10-6

10-8

10-7

10-7

10-6

10-7

10-6

35 Manganese (as Mn),

mg/L

2 2 - 2

36 Iron (as Fe), mg/L 3 3 - 3

37 Vanadium (as V), mg/L 0.2 - 0.2 0.2

38 Nitrate Nitrogen, mg/L 18 20 - 0.2

A- 12

ANNEXURE – 7

APPLICATION FOR GROUND WATER WITHDRAWAL PERMISSION FROM CGWA

A- 13

ANNEXURE – 8

COPY OF ACCEPTANCE LETTER FOR FLY ASH FOR BRICK MANUFACTURING &

MEMORANDUM OF UNDERSTANDING SIGNED WITH CEMENT MANUFACTURER FOR CO-

PROCESSING OF ORGANIC WASTE & COAL SUPPLY LETTER

A- 14

A- 15

A- 16

A- 17

COPY OF COAL SUPPLY LETTER

A- 18

ANNEXURE – 9

MEMBERSHIP CERTIFICATES FROM COMMON ENVIRONMENTAL INFRASTRUCTURE

FACILITIES (TSDF & CHWIF)

A- 19

A- 20

ANNEXURE – 10

COPY OF CERTIFIED REPORT BY RO, MOEF & ITS COMPLIANCE

Attached Separately

A- 21

ANNEXURE – 11

PUBLIC HEARING MINUTES

Attached Separately

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ANNEXURE – 12

COPY OF MATERIAL SAFETY DATA SHEETS

MSDS Number: T3913 * * * * * Effective Date: 08/03/04 * * * * * Supercedes: 11/02/01

TOLUENE

1. Product Identification

Synonyms: Methylbenzene; Toluol; Phenylmethane

CAS No.: 108-88-3

Molecular Weight: 92.14

Chemical Formula: C6H5-CH3

Product Codes: J.T. Baker: 5375, 5812, 9336, 9351, 9364, 9456, 9457, 9459, 9460, 9462, 9466, 9472, 9476

Mallinckrodt: 4483, 8092, 8604, 8608, 8610, 8611, V560

2. Composition/Information on Ingredients

Ingredient CAS No Percent Hazardous

--------------------------------------- ------------ ------------ ---------

Toluene 108-88-3 100% Yes

3. Hazards Identification

Emergency Overview --------------------------

POISON! DANGER! HARMFUL OR FATAL IF SWALLOWED. HARMFUL IF

INHALED OR ABSORBED THROUGH SKIN. VAPOR HARMFUL. FLAMMABLE

LIQUID AND VAPOR. MAY AFFECT LIVER, KIDNEYS, BLOOD SYSTEM, OR

CENTRAL NERVOUS SYSTEM. CAUSES IRRITATION TO SKIN, EYES AND

RESPIRATORY TRACT.

SAF-T-DATA(tm) Ratings (Provided here for your convenience)

-----------------------------------------------------------------------------------------------------------

Health Rating: 2 - Moderate (Life)

Flammability Rating: 3 - Severe (Flammable)

A- 23

Reactivity Rating: 1 - Slight

Contact Rating: 3 - Severe (Life)

Lab Protective Equip: GOGGLES & SHIELD; LAB COAT & APRON; VENT HOOD;

PROPER GLOVES; CLASS B EXTINGUISHER

Storage Color Code: Red (Flammable)

-----------------------------------------------------------------------------------------------------------

Potential Health Effects ----------------------------------

Inhalation: Inhalation may cause irritation of the upper respiratory tract. Symptoms of overexposure may

include fatigue, confusion, headache, dizziness and drowsiness. Peculiar skin sensations (e. g.

pins and needles) or numbness may be produced. Very high concentrations may cause

unconsciousness and death.

Ingestion: Swallowing may cause abdominal spasms and other symptoms that parallel over-exposure

from inhalation. Aspiration of material into the lungs can cause chemical pneumonitis, which

may be fatal.

Skin Contact: Causes irritation. May be absorbed through skin.

Eye Contact: Causes severe eye irritation with redness and pain.

Chronic Exposure: Reports of chronic poisoning describe anemia, decreased blood cell count and bone marrow

hypoplasia. Liver and kidney damage may occur. Repeated or prolonged contact has a

defatting action, causing drying, redness, dermatitis. Exposure to toluene may affect the

developing fetus.

Aggravation of Pre-existing Conditions: Persons with pre-existing skin disorders or impaired liver or kidney function may be more

susceptible to the effects of this substance. Alcoholic beverage consumption can enhance the

toxic effects of this substance.

4. First Aid Measures

Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is

difficult, give oxygen. CALL A PHYSICIAN IMMEDIATELY.

Ingestion: Aspiration hazard. If swallowed, DO NOT INDUCE VOMITING. Give large quantities of

water. Never give anything by mouth to an unconscious person. Get medical attention

immediately. If vomiting occurs, keep head below hips to prevent aspiration into lungs.

Skin Contact: In case of contact, immediately flush skin with plenty of soap and water for at least 15

minutes while removing contaminated clothing and shoes. Wash clothing before reuse. Call a

physician immediately.

Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper

eyelids occasionally. Get medical attention immediately.

A- 24

5. Fire Fighting Measures

Fire: Flash point: 7C (45F) CC

Autoignition temperature: 422C (792F)

Flammable limits in air % by volume:

lel: 3.3; uel: 19

Flammable liquid and vapor!

Dangerous fire hazard when exposed to heat or flame. Vapors can flow along surfaces to

distant ignition source and flash back.

Explosion: Above flash point, vapor-air mixtures are explosive within flammable limits noted above.

Contact with strong oxidizers may cause fire or explosion. Sensitive to static discharge.

Fire Extinguishing Media: Dry chemical, foam or carbon dioxide. Water may be used to flush spills away from

exposures and to dilute spills to non-flammable mixtures.

Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained

breathing apparatus with full facepiece operated in the pressure demand or other positive

pressure mode. Water spray may be used to keep fire exposed containers cool.

6. Accidental Release Measures

Ventilate area of leak or spill. Remove all sources of ignition. Wear appropriate personal

protective equipment as specified in Section 8. Isolate hazard area. Keep unnecessary and

unprotected personnel from entering. Contain and recover liquid when possible. Use non-

sparking tools and equipment. Collect liquid in an appropriate container or absorb with an

inert material (e. g., vermiculite, dry sand, earth), and place in a chemical waste container. Do

not use combustible materials, such as saw dust. Do not flush to sewer! If a leak or spill has

not ignited, use water spray to disperse the vapors, to protect personnel attempting to stop

leak, and to flush spills away from exposures. US Regulations (CERCLA) require reporting

spills and releases to soil, water and air in excess of reportable quantities. The toll free

number for the US Coast Guard National Response Center is (800) 424-8802.

J. T. Baker SOLUSORB® solvent adsorbent is recommended for spills of this product.

7. Handling and Storage

Protect against physical damage. Store in a cool, dry well-ventilated location, away from any

area where the fire hazard may be acute. Outside or detached storage is preferred. Separate

from incompatibles. Containers should be bonded and grounded for transfers to avoid static

sparks. Storage and use areas should be No Smoking areas. Use non-sparking type tools and

equipment, including explosion proof ventilation. Containers of this material may be

hazardous when empty since they retain product residues (vapors, liquid); observe all

warnings and precautions listed for the product.

8. Exposure Controls/Personal Protection

Airborne Exposure Limits: Toluene:

- OSHA Permissible Exposure Limit (PEL):

200 ppm (TWA); 300 ppm (acceptable ceiling conc.); 500 ppm (maximum conc.).

- ACGIH Threshold Limit Value (TLV):

50 ppm (TWA) skin, A4 - Not Classifiable as a Human Carcinogen.

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Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures below

the Airborne Exposure Limits. Local exhaust ventilation is generally preferred because it can

control the emissions of the contaminant at its source, preventing dispersion of it into the

general work area. Please refer to the ACGIH document, Industrial Ventilation, A Manual of

Recommended Practices, most recent edition, for details.

Personal Respirators (NIOSH Approved): If the exposure limit is exceeded and engineering controls are not feasible, a half-face organic

vapor respirator may be worn for up to ten times the exposure limit, or the maximum use

concentration specified by the appropriate regulatory agency or respirator supplier, whichever

is lowest. A full-face piece organic vapor respirator may be worn up to 50 times the exposure

limit, or the maximum use concentration specified by the appropriate regulatory agency or

respirator supplier, whichever is lowest. For emergencies or instances where the exposure

levels are not known, use a full-face piece positive-pressure, air-supplied respirator.

WARNING: Air-purifying respirators do not protect workers in oxygen-deficient

atmospheres.

Skin Protection: Wear impervious protective clothing, including boots, gloves, lab coat, apron or coveralls, as

appropriate, to prevent skin contact.

Eye Protection: Use chemical safety goggles and/or a full face shield where splashing is possible. Maintain

eye wash fountain and quick-drench facilities in work area.

9. Physical and Chemical Properties

Appearance: Clear, colorless liquid.

Odor: Aromatic benzene-like.

Solubility: 0.05 gm/100gm water @ 20C (68F).

Specific Gravity: 0.86 @ 20C / 4 C

pH: No information found.

% Volatiles by volume @ 21C (70F): 100

Boiling Point: 111C (232F)

Melting Point: -95C (-139F)

Vapor Density (Air=1): 3.14

Vapor Pressure (mm Hg): 22 @ 20C (68F)

Evaporation Rate (BuAc=1): 2.24

10. Stability and Reactivity

Stability: Stable under ordinary conditions of use and storage. Containers may burst when heated.

A- 26

Hazardous Decomposition Products: Carbon dioxide and carbon monoxide may form when heated to decomposition.

Hazardous Polymerization: Will not occur.

Incompatibilities: Heat, flame, strong oxidizers, nitric and sulfuric acids, chlorine, nitrogen tetraoxide; will

attack some forms of plastics, rubber, coatings.

Conditions to Avoid: Heat, flames, ignition sources and incompatibles.

11. Toxicological Information

Toxicological Data: Oral rat LD50: 636 mg/kg; skin rabbit LD50: 14100 uL/kg; inhalation rat LC50: 49

gm/m3/4H; Irritation data: skin rabbit, 500 mg, Moderate; eye rabbit, 2 mg/24H, Severe.

Investigated as a tumorigen, mutagen, reproductive effector.

Reproductive Toxicity: Has shown some evidence of reproductive effects in laboratory animals. --------\Cancer Lists\------------------------------------------------------

---NTP Carcinogen---

Ingredient Known Anticipated IARC Category

------------------------------------ ----- ----------- -------------

Toluene (108-88-3) No No 3

12. Ecological Information

Environmental Fate: When released into the soil, this material may evaporate to a moderate extent. When released

into the soil, this material is expected to leach into groundwater. When released into the soil,

this material may biodegrade to a moderate extent. When released into water, this material

may evaporate to a moderate extent. When released into water, this material may biodegrade

to a moderate extent. When released into the air, this material may be moderately degraded

by reaction with photochemically produced hydroxyl radicals. When released into the air, this

material is expected to have a half-life of less than 1 day. This material is not expected to

significantly bioaccumulate. This material has a log octanol-water partition coefficient of less

than 3.0. Bioconcentration factor = 13.2 (eels).

Environmental Toxicity: This material is expected to be toxic to aquatic life. The LC50/96-hour values for fish are

between 10 and 100 mg/l.

13. Disposal Considerations

Whatever cannot be saved for recovery or recycling should be handled as hazardous waste

and sent to a RCRA approved incinerator or disposed in a RCRA approved waste facility.

Processing, use or contamination of this product may change the waste management options.

State and local disposal regulations may differ from federal disposal regulations. Dispose of

container and unused contents in accordance with federal, state and local requirements.

14. Transport Information

Domestic (Land, D.O.T.) -----------------------

Proper Shipping Name: TOLUENE

Hazard Class: 3

UN/NA: UN1294

Packing Group: II

A- 27

Information reported for product/size: 390LB

International (Water, I.M.O.) -----------------------------


Hazard Class: 3

UN/NA: UN1294

Packing Group: II


15. Regulatory Information

--------\Chemical Inventory Status - Part 1\---------------------------------

Ingredient TSCA EC Japan Australia

----------------------------------------------- ---- --- ----- ---------

Toluene (108-88-3) Yes Yes Yes Yes


--Canada--

Ingredient Korea DSL NDSL Phil.

----------------------------------------------- ----- --- ---- -----

Toluene (108-88-3) Yes Yes No Yes

--------\Federal, State & International Regulations - Part 1\----------------

-SARA 302- ------SARA 313------

Ingredient RQ TPQ List Chemical Catg.

----------------------------------------- --- ----- ---- --------------

Toluene (108-88-3) No No Yes No


-RCRA- -TSCA-

Ingredient CERCLA 261.33 8(d)

----------------------------------------- ------ ------ ------

Toluene (108-88-3) 1000 U220 No

Chemical Weapons Convention: No TSCA 12(b): No CDTA: Yes

SARA 311/312: Acute: Yes Chronic: Yes Fire: Yes Pressure: No

Reactivity: No (Pure / Liquid)

WARNING: THIS PRODUCT CONTAINS A CHEMICAL(S) KNOWN TO THE STATE OF

CALIFORNIA TO CAUSE BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM.

Australian Hazchem Code: 3[Y]E

Poison Schedule: S6

WHMIS: This MSDS has been prepared according to the hazard criteria of the Controlled Products

Regulations (CPR) and the MSDS contains all of the information required by the CPR.

16. Other Information

NFPA Ratings: Health: 2 Flammability: 3 Reactivity: 0

Label Hazard Warning: POISON! DANGER! HARMFUL OR FATAL IF SWALLOWED. HARMFUL IF



A- 28


RESPIRATORY TRACT.

Label Precautions: Keep away from heat, sparks and flame.

Keep container closed.

Use only with adequate ventilation.

Wash thoroughly after handling.

Avoid breathing vapor.

Avoid contact with eyes, skin and clothing.

Label First Aid: Aspiration hazard. If swallowed, DO NOT INDUCE VOMITING. Give large quantities of

water. Never give anything by mouth to an unconscious person. If vomiting occurs, keep

head below hips to prevent aspiration into lungs. If inhaled, remove to fresh air. If not

breathing, give artificial respiration. If breathing is difficult, give oxygen. In case of contact,

immediately flush eyes or skin with plenty of water for at least 15 minutes. Remove

contaminated clothing and shoes. Wash clothing before reuse. In all cases call a physician

immediately.

Product Use: Laboratory Reagent.

Revision Information: MSDS Section(s) changed since last revision of document include: 3.

Disclaimer: ***************************************************************************

*********************

Mallinckrodt Baker, Inc. provides the information contained herein in good faith but

makes no representation as to its comprehensiveness or accuracy. This document is

intended only as a guide to the appropriate precautionary handling of the material by a

properly trained person using this product. Individuals receiving the information must

exercise their independent judgment in determining its appropriateness for a particular

purpose. MALLINCKRODT BAKER, INC. MAKES NO REPRESENTATIONS OR

WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT

LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A

PARTICULAR PURPOSE WITH RESPECT TO THE INFORMATION SET FORTH

HEREIN OR THE PRODUCT TO WHICH THE INFORMATION REFERS.

ACCORDINGLY, MALLINCKRODT BAKER, INC. WILL NOT BE RESPONSIBLE

FOR DAMAGES RESULTING FROM USE OF OR RELIANCE UPON THIS

INFORMATION. ***************************************************************************

*********************

Prepared by: Environmental Health & Safety

Phone Number: (314) 654-1600 (U.S.A.)

A- 29

Ammonia

Formula H3N (H3N)

Structure

Description Colorless liquid, aqueous ammonia solution. Concentrations of solutions

range up to approximately 30% ammonia.

Uses Manufacture nitric acid, explosives, synthetic fibers, fertilizers, in

refrigeration & chemical industry.

Registry Numbers and Inventories.

CAS 7664-41-7

EC

(EINECS/ELINCS) 231-635-3

EC Index Number 007-001-00-5

EC Class Flammable; Toxic; Corrosive; Dangerous for the Environment

EC Risk Phrase

R 10

T; R 23

C; R 34

N; R 50

EC Safety Phrase S: (1/2-)9-16-26-36/37/39-45-61

ENCS (MITI) 1-391

RTECS BO0875000

RTECS class Agricultural Chemical and Pesticide (A); Tumorigen (C); Mutagen

(M); Human Data (P)

UN (DOT) 1005

Merck 12,517

Listed on the Toxic Substancs Control Act (TSCA).

Listed on Canadian Domestic Substances List (DSL).

Listed on Australian Inventory of Chemical Substances (AICS).

Properties.

Formula mass 17.03

Melting point, °C -77.7

Boiling point, °C -33.34

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Vapor pressure, mmHg 7510 (25 °C)

Vapor density (air=1) 0.597

Critical temperature 132.4 °C

Critical pressure 111.5 atm

Density 0.77 g/cm3

Solubility in water 54 g/100 mL

Viscosity 0.475 cp

Surface tension 23.4 dynes/cm at 11.1°C

Acid/Base 4.75 (pKb)

Heat of vaporization 5.581 kcal/mole

Heat of combustion -7992 btu/lb

Odor threshold 0.0266 mg/m3

Hazards and Protection.

Storage

Keep in a cool, dry, dark location in a tightly sealed container or

cylinder. Keep away from incompatible materials, ignition sources and

untrained individuals. Secure and label area. Protect

containers/cylinders from physical damage.

Handling

All chemicals should be considered hazardous. Avoid direct physical

contact. Use appropriate, approved safety equipment. Untrained

individuals should not handle this chemical or its container. Handling

should occur in a chemical fume hood.

Protection Wear appropriate protective gloves, clothing and goggles.

Respirators Wear positive pressure self-contained breathing apparatus (SCBA).

Small spills/leaks

Keep material out of water sources and sewers. Attempt to stop leak if

without undue personnel hazard. Use water spray to knock-down

vapors. Vapor knockdown water is corrosive or toxic and should be

diked for containment. Land spill: Dig a pit, pond, lagoon, holding area

to contain liquid or solid material. Dike surface flow using soil, sand

bags, foamed polyurethane, or foamed concrete. Absorb bulk liquid

with fly ash or cement powder. Neutralize with vinegar or other dilute

acid. Water spill: Neutralize with dilute acid. Use mechanical dredges

or lifts to remove immobilized masses of pollutants and precipitates.

Stability Stable. Reactive only under extreme conditions. Reacts vigorously with

oxidizing materials..

Incompatibilities Reacts violently or produces explosive products with fluorine, chlorine,

bromine and iodine and bromine pentafluoride and chlorine trifluoride

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May react violently with boron halides, ethylene oxide

(polymerization), perchlorates and strong oxidizing agents (chromyl

chloride, chromium trioxide, chromic acid, nitric acid, hydrogen

peroxide, chlorates, fluorine, nitrogen oxide, liquid oxygen).

Decomposition hock-sensitive compounds are formed with mercury, silver and gold

oxides.

Other hazards Liquid ammonia can cause ignition if sprayed in a tank containing air.

Fire.

Flash Point,°C 11

Autoignition, °C 651

Upper exp. limit, % 30

Lower exp. limit, % 15

Fire fighting

Wear positive pressure breathing apparatus and full protective

clothing.Small fires: dry chemical or carbon dioxide. Large fires:

water spray, fog or foam. Apply water gently to the surface. Do not

get water inside container. Move container from fire area if you can

do it without risk. Stay away from ends of tanks. Cool containers

that are exposed to flames with water from the side until well after

fire is out. Isolate area until gas has dispersed.

Fire potential

Slightly flammable. Will burn at high concentration. At 1290

fahrenheit or in presence of electric spark decomposes into n and h.

Forms flammable mixtures with air. Presence of combustibles

increases hazard.

Hazards

Mixing of ammonia with several chemicals can cause severe fire

hazards and/or explosions. Ammonia in container may explode in

heat of fire. Incompatible with many materials including silver and

gold salts, halogens, alkali metals, nitrogen trichloride, potassium

chlorate, chromyl chloride, oxygen halides, acid vapors, azides,

ethylene oxide, picric acid and many other chemicals. Mixing with

other chemicals and water. Hazardous polymerization may not

occur.

NFPA Health 3

Flammability 1

Reactivity 0

Special -

Health.

A- 32

Exposure limit(s)

OSHA PEL: TWA 50 ppm (35 mg/m3)

NIOSH REL: TWA 25 ppm (18 mg/m3) ST 35 ppm (27 mg/m

3)

NIOSH IDLH: 300 ppm

Exposure effects

Increases in blood pressure and pulse have been reported. An

altered mental status (coma) may be seen, but is not

characteristic unless hypoxemia occurs. Seizures may occur with

extensive absorption. Decreased egg production has occurred in

experimental animals. Ammonia crosses the ovine placental

barrier.

No information about possible male reproductive effects was

found in available references.

Ingestion

Nausea and vomiting occur frequently following ingestion.

Swelling of the lips, mouth, and larynx, and oral or esophageal

burns may occur if concentrated ammonia solutions are ingested.

Inhalation Vapors are extremely irritating and corrosive.

Skin Concentrated ammonia may produce liquifaction necrosis and

deep penetrating burns.

First aid

Ingestion Seek medical assistance.

Inhalation

Move victim to fresh air. Apply artificial respiration if victim is

not breathing. Do not use mouth-to-mouth method if victim

ingested or inhaled the substance; induce artificial respiration

with the aid of a pocket mask equipped with a one-way valve or

other proper respiratory medical device. Administer oxygen if

breathing is difficult. Effects may be delayed.

Skin

Remove contaminated clothing and wash exposed area

thoroughly with soap and water. A physician should examine the

area if irritation or pain persists.

Transport.

UN number 1005

Response guide 125

Hazard class 2.3

USCG CHRIS Code AMA

USCG

Compatatibility

Group

6 Ammonia

A- 33

Solaris ChemTech Industries Limited, Unit: Karwar

Material Safety Data Sheet Product : SUBSTANCE NAME : CAUSTIC SODA LYE (47 % w/w min.) Date of print: 11/06/2009 1. SUBSTANCE/ PREPARATION AND COMPANY IDENTIFICATION

SUBSTANCE NAME: CAUSTIC SODA LYE (Sodium Hydroxide -Lye) Use: Inorganic and organic chemistry industry, alumina production; soap and surfactants; textile industry; oil and gas processing; rayon industry; pulp and paper industry; food industry; water treatment; agricultural industry. Company : Solaris ChemTech Indusrties limited

Company Name and Address : Solaris ChemTech Indusrties limited

P.O. : BINAGA –581 307, Karwar UTTAR KANNADA DIST. KARNAKAKA Telephone : 08382 -230174, 230178, 230514 Telefax number : 08382 –230468 E-mail address : [email protected] [email protected] Emergency Information: Emergency information Address : As stated above Telephone : As stated above Telefax number : As stated above 2. COMPOSITION / INFORMATION ON INGREDIENTS Chemical nature : Alkaline inorganic compound Component CAS # % (by weight) -dry basis

Sodium hydroxide 1310-73-2 99.5 minimum

Sodium carbonate 497-19-8 0.4 Max.

Sodium chloride 7647-14-5 0.01 Max.

Sodium sulphate 7757-82-6 0.001 Max.

Sodium Silicate as SiO2 6834-92-0 0.02 Max. Iron 7439-89-6 10.0 Max.

Copper as Cu 7440-50-8 1.0 ppm, max

Manganese as Mn 7439-96-5 1.0ppm max.

Water 7732-18-5 Balance

CAS Number : 1310-73-2

EC INDEX Number : 011-002-00-6

Page 2 of 7 3. HAZARD IDENTIFICATION EMERGENCY OVERVIEW: Colourless, odourless liquid Extremely corrosive! Contact can cause eye burns and permanent tissue damage. May be fatal if swallowed. The severity of damage on the concentration of the caustic and the duration of the exposure. Reactive with water and numerous commonly encountered materials, generating heat. Contact with some metals release flammable hydrogen gas. Highly toxic to fish and other water organisms Potential Health. Effects: EYE: Eye contact of only a few seconds can cause permanent damage, even blindness SKIN: Contact may cause severe irritation or corrosive skin damage, depending upon the length of contact, amount of caustic and concentration. INHALATION: Inhalation of caustic aerosols including mists, vapours, gas, fog and other airborne forms of any particle size causes irritation to destructive burns of the upper respiratory tract. High or prolonged inhalation exposure may lead to corrosion of mucus membranes and pneuminitis. Fatality may occur from gross overexposure.

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INGESTION: Ingestion may cause severe caustic burns to the mouth, throat, esophagus and stomach. Gross ingestion may cause death. Severe scaring of the throat may occur on recovery. Symptoms may include bleeding, vomiting, fall in blood pressure. Damage may appear days after exposure. CHRONIC (CANCER) INFORMATION: Not known to cause cancer. Not listed as carcinogen by IARC, NTP, OSHA or ACGIH. POTENTIAL ENVIRONMENTAL EFFECTS: Extremely toxic to aquatic life on an acute basis 4. FIRST-AID MEASURES General advice : EYES: Immediately flush eyes with clean water for at least 15 minutes, lifting eyelids to thoroughly flush. DO NOT try to neutralize the caustic. Contact Physician immediately (contact during flushing expedites process). Apply cool packs on eyes while transporting victim to medical facility. SKIN : Immediately flush affected area with water for at least 15 minutes, removing all contaminated clothing while flushing. Contact Physician immediately ( contact during flushing expedites process). Keep affected area cool. INHALATION : Remove to fresh air. Contact Physician immediately. Check for breathing and pulse. If breathing is difficult, give oxygen (6 liters per minute). If breathing has stopped, give artificial respiration. Keep victim warm and at rest. INGESTION : DO NOT induce vomiting. Contact Physician immediately. Give large quantities of water only if victim is conscious. Keep warm and at rest. NOTES TO PHYSICIAN Eye and Skin:

η Treat symptomatically Inhalation:

η Individuals with pre-existing lung conditions may have increased susceptibility to the toxicity of excessive exposure Page 3 of 7 Ingestion:

η Perform endoscopy in all cases of suspected sodium hydroxide ingestion. In cases of severe esophagal corrosion, the use of therapeutic doses of steroids should be considered. General supportive measures with continual monitoring of gas exchange, acd-base balance, electrolytes and intake are also required. 5. FIRE-FIGHTING MEASURES Suitable extinguishing media: Use extinguishing media compatible with caustic and appropriate for the burning fire, such as foam, carbon dioxide or dry chemicals. Avoid water use if possible. Special protective equipment : Provide covered safety goggles, face-shield, dust type respirator, rubber shoes and PVC or rubber hand gloves. Further information : Material is non-combustible. Keep the containers cool by spraying water, if exposed to heat or flame. Unusual Hazards : Emits toxic fumes of Na2O on combustion. For potential exposure to caustic fumes, wear full protective clothing with hood and breathing air supply 6. ACCIDENTAL RELEASE MEASURES Personal precautions: Use specified Personal Protection Equipments Environmental precautions : Avoid water use if possible. Runoff from washing may cause pollution. Neutralize alkaline washings with dilute acetic acid or dilute hydrochloric acid. Methods for cleaning up or taking up For small amounts: Wash with minimum quantity of water and collect washings in a pond and neutralize using with dilute acetic acid or dilute hydrochloric acid.

A- 35

For large amounts : Evacuate personnel. Wear proper personal protective clothing. Stop leak at source. Contain released material by using soil, sand bags, foamed polyurethane or foam concrete Reclaim material if possible. Pump to proper container. Neutralise alkaline washings and surfaces with dilute acetic acid or dilute hydrochloric acid. In all instances, notify appropriate authorities if required by regulations

7. HANDLING AND STORAGE Storage Suitable materials for containers: Mild steel for caustic lye with temperature less than 400C. Nickel and/or its alloys are used for caustic solutions at elevated temperatures Further information on storage conditions: Hot (>400 C) caustic lye stored in mild steel container, corrodes MS surface and becomes black. Never add water to caustic soda. Add caustic soda to luke warm water. The addition of caustic soda to water will cause a rise in temperature. If caustic soda becomes concentrated in one area, or is added too rapidly, or is added to hot or cold liquid, a rapid temperature increase can result in dangerous mists or boiling or spattering, which may cause an immediate violent eruption. Storage stability: Normally stable. Storage temperature: Store in a well-ventilated place above 160C. DO NOT store or mix with water, acids, flammable liquids, organic halogens, nitromethanes and metals such as aluminium, tin and zinc. Storage duration: No storage period data available. Keep containers closed. Sodium hydroxide rapidly absorbs carbon dioxide from air forming sodium carbonate. A crust of sodium carbonate is formed on the Page 4 of 7 air-exposed surface. 8. EXPOSURE CONTROLS AND PERSONAL PROTECTION Personal protective equipment Hand protection: Neoprene or PVC hand gloves Supplementary note: ENGINEERING CONTROLS: Provide general and/or local exhaust ventilation to control airborne concentrations below recommended exposure guidelines. RESPIRATORY PROTECTION: When exposure levels could exceed 2 mg/M3, a NIOSH approved airpurifying full-face respirator with high-efficiency particulate filters is recommended. When exposure levels could exceed 10 mg/M3 , a self-contained breathing apparatus with a full face piece is recommended. SKIN PROTECTION: Use protective clothing impervious to caustic such as neoprene or polyvinyl chloride (PVC). Use precautions to ensure all potentially affected body parts are covered, such as taping sleeves and pant legs to gloves and boots, respectively, and buttoning clothing to the neck. Selection of specific items such as gloves, coats, pants, bots, aprons or full-body suits will depend on operations to be performed. Avoid leather and wool. Safety shower should be located in immediate work area. EYE PROTECTION: Contact lenses should not be worn; they could contribute to severe eye damage. Wear close-fitting chemical splash goggles as a minimum. Where splash hazard to face is present, also wear a full-length transparent face shield. GENERAL HYGIENE CONSIDERATIONS: Follow good industrial hygiene practices including but not limited to: (1) wash hands after use and before eating; (2) avoid contact with material;(3) avoid breathing vapours; and wear appropriate safety equipment. EXPOSURE GUIDELINES: Sodium hydroxide solutions:

A- 36

PEL (OSHA) : 2 mg/M3

TLV (ACGIH) : 2 mg/M3

IDLH (NIOSH) : 10 mg/M3

9. PHYSICAL AND CHEMICAL PROPERTIES Form : Liquid Colour : Colour less to slightly gray Odour : Odourless Solidification temperature : 120 C Boiling point : 145 0 C for 50 % lye Flash point : Not pertinent Lower explosion limit : Not pertinent Upper explosion limit : Not pertinent Ignition temperature : Not pertinent Vapour pressure : 1.5 mm Hg @ 200 C Density : 1.53 for 50 %lye at 200C Solubility in water : 100 % Solubility (quantitative) solvent(s) : 109 g/100 g water at 200 C Viscosity, dynamic : 78.0 cP at 200 C 10. STABILITY AND REACTIVITY Page 5 of 7 Condition to avoid: Keep away from heat, sparks or flames. DO NOT store or mix with incompatible materials. Substances to avoid: Water, acids, flammable liquids, organic halides, nitrobenzene, metals such as aluminium, tin, and zinc, bronze, copper, lead and other alkali sensitive metals and alloys. Contact to some metals can generate hydrogen gas. Under certain conditions of temperature, pressure and state of division, it can react or ignit violently with acetic acid, acetaldehyde, acetic anhydride, acrolein, acrylonitrile, allyl alcohol, allyl chloride. 11. TOXICOLOGICAL INFORMATION LD 50/oral/rat: 104-340mg/kg by inhalation/rat: not known Inhalation risk test (IRT) : not known LD50 /dermal/rabbit: 1359 mg/kg @ 100% NaOH Literature data : 400ug eyes-rabbit mild; 1% eyes rabbit sever; 50 ug/24 hours eyes-rabbit sever; 1 mg /24 hour eyes rabbit sever. Primary skin irritation/rabbit: 500 mg/24 h severe Primary irritations of the mucous membrane/rabbit: Not available Experiences in humans: EYE: Eye contact of only a few seconds can cause permanent damage, even blindness SKIN: Contact may cause severe irritation or corrosive skin damage, depending upon the length of contact, amount of caustic and concentration. 2 % / 24 hours skin-human mild. INHALATION: Inhalation of caustic aerosols including mists, vapours, gas, fog and other airborne forms of any particle size causes irritation to destructive burns of the upper respiratory tract. High or prolonged inhalation exposure may lead to corrosion of mucus membranes and pneuminitis. Fatality may occur from gross overexposure. INGESTION: Ingestion may cause severe caustic burns to the mouth, throat, esophagus and stomach. Gross ingestion may cause death. Severe scarring of the throat may occur on recovery. Symptions may include bleeding, vomiting, fall in blood pressure. Damage may appear days after exposure Skin resorption hazard: Reported human Effects – Full destruction of tissue with prolonged contact. 12. ECOLOGICAL INFORMATION Ecotoxicity Toxicity to fish: This material has exhibited moderate to high toxicity to fish and other

A- 37

aquatic organisms due to likely rise in water pH and /or heat generation. Fish toxicity : 240 ug/L 96 hours LC50 (Mortality) Bluegill (Lepomis macrochirus) Fish name /LC50 - Daphina: 100 ppm; Brook trout: 25 ppm 24 hours; Shrimp : 100 ppm 48 hours; Cockle: 330 – 1000 ppm 48 hours Aquatic invertebrates: 330000-1000000 ug/L 48 hours LC50 (Mortality) Cockle (Cerastoderma edule) Literature data. Aquatic plants: Algal Toxicity: 765 ug/L 30 days (Biomass) Algae, phytoplankton, algal mat (Algae) Persistence and degradability : This material is believed to exist in the disassociated state in the environment. This material is believed not to bioaccumalate. Page 6 of 7 Bioaccumulation potential This material is believed not to bioaccumulate. 13. DISPOSAL CONSIDERATIONS If this product supplied becomes a waste, it mee the criteria of a hazardous waste (corrosivity, EPA hazardous waste number D002). Dispose of in accordance with local, Provincial/State and Federal laws and regulations 14. TRANSPORT INFORMATION Proper shipping name: Sodium hydroxide solution Hazard Class: 8 (Corrosive) Identification Number: UN1824 Packing Group: II 15. REGULATORY INFORMATION Regulations of the European union (Labeling) / National legislation/ Regulations EC-Number : 215-185-5 as in Directive 67/548/EEC: Hazard symbol (s): CORROSIVE C R-Phrase(s): R35 Causes severe burns S-Phrase(s): S26, S37, S39, S45 S26 Incase of contact with eyes, rinse immediately with plenty of water and seek medical advice. S37 Wear suitable gloves S39 Wear eye / face protection S45 Incase of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible)

Hazard determinant component(s) for labeling : Other regulations NFPA Rating: Health –3; Flammability –0; Reactivity-1; Special Precautions –Corrosive HMIS Rating: Health –3; Falmmability –0; Reactivity –2; Protective Equipment -H

16. OTHER INFORMATION This product is manufactured by mercury cell process. Important: The information provided, herein, relates only to the specific material described herein and does not relate to its use by customer, whether alone or in combination with any other material in any process. The information set forth, herein, furnished is based on technical data accessed on Internet and Solaris ChemTech Industries Limited (SCIL) does not make any representation or warranty as to the accuracy or completeness of this information. This information is intended for use by persons having technical skill and at their own discretion and risk. Customer is responsible for determining whether the information included herein, is appropriate for customer’s use and customer assumes full responsibility for conclusions it derives from this information. In as much as SCIL has no reason to know how customer intends to use the information provided herein, and since conditions of use are outside our control, we make no warranties, express or implied, and assumes no liability in connection with any use of this information. Nothing herein is to be taken as a license to operate under or a recommendation to infringe any patent.

A- 38

Ethyl acetate

• Acetic acid, ethyl ester

• Acetoxy ethane

• Acetic ether

Formula CH3COOC2H5 (C4H8O2)

Structure

Description Clear, colorless liquid with a fruity odor.

Uses Solvent.


CAS 141-78-6

EC



EC Class Highly flammable; Irritant; Repeated exposure may cause skin

dryness or cracking; Vapours may cause drowsiness and dizziness

EC Risk Phrase R 11-36-66-67

EC Safety Phrase S 16-26-33

ENCS (MITI) 2-726

RTECS AH5425000

RTECS class Agricultural Chemical and Pesticide (A); Mutagen (M); Human Data

(P); Primary Irritant (S)

RCRA U112

UN (DOT) 1173

Merck 13,3792

Beilstein ref. 4-02-00-00127




Properties.

Formula mass 88.11

A- 39

Melting point, °C -83

Boiling point, °C 77.1



Critical temperature 250 °C

Critical pressure 28877 torr

Density 0.902 g/cm3 (20 °C)

Solubility in water 10 g/100ml

Viscosity 0.428 cp (25 °C)

Surface tension 23.6 dyne/cm (20 °C)

Refractive index 1.3719 (20 °C)

Partition coefficient, pKow

0.73

Heat of fusion 9420 J/mol

Heat of vaporization 35560 J/mol

Heat of combustion -2.28837x10^6 J/mol

Odor threshold 0.006 - 0.686 mg/L


Storage

Keep away from heat, sparks, and flame. Keep away from sources of

ignition. Store in a tightly closed container. Store in a cool, dry, well-

ventilated area away from incompatible substances.

WHMIS B2 - Flammable and combustible material - Flammable liquid

Handling

Wash thoroughly after handling. Use with adequate ventilation. Ground

and bond containers when transferring material. Avoid contact with

eyes, skin, and clothing. Empty containers retain product residue,

(liquid and/or vapor), and can be dangerous. Keep container tightly

closed. Avoid contact with heat, sparks and flame. Avoid ingestion and

inhalation. Do not pressurize, cut, weld, braze, solder, drill, grind, or

expose empty containers to heat, sparks or open flames.


Respirators

Follow the OSHA respirator regulations found in 29CFR 1910.134 or

European Standard EN 149. Always use a NIOSH or European

Standard EN 149 approved respirator when necessary.

A- 40

Small spills/leaks

Avoid runoff into storm sewers and ditches which lead to waterways.

Remove all sources of ignition. Absorb spill using an absorbent, non-

combustible material such as earth, sand, or vermiculite. Provide

ventilation. A vapor suppressing foam may be used to reduce vapors.

Water spray may reduce vapor but may not prevent ignition in closed

spaces.

Disposal code 1

Stability Stable under normal shipping and handling conditions.

Incompatibilities

Chlorosulfonic acid, lithium aluminum hydride + 2-chloromethylfuran,

lithium tetrahydroaluminate, oleum, potassium t-butoxide. Substance

coming in contact with nitrates or strong acids/oxidizers/alkalies may

cause fire.

Decomposition No data available.

Other hazards Acid type corrosions evident in moist environment.

Fire.

Flash Point,°C -4


Upper exp. limit, % 11.5

Lower exp. limit, % 2.1

Fire fighting

Do not extinguish fire unless flow can be stopped. Use water in

flooding quantities as fog. Solid streams of water may be

ineffective. Cool all affected containers with flooding quantities of

water. Apply water from as far a distance as possible. Use alcohol

foam, dry chemical or carbon dioxide.

Fire potential HIGHLY FLAMMABLE.

Hazards

Vapors may form explosive mixtures with air. Vapors may travel to

source of ignition and flash back. Most vapors are heavier than air.

They will spread along ground and collect in low or confined areas

(sewers, basements, tanks). Vapor explosion hazard indoors,

outdoors or in sewers. May polymerize explosively when heated or

involved in a fire. Runoff to sewer may create fire or explosion

hazard. Containers may explode when heated. Many liquids are

lighter than water.

Combustion products Fire may produce irritating, corrosive and/or toxic gases.

NFPA Health 1

A- 41

Flammability 3

Reactivity 0

Special -

Health.

Exposure limit(s)

TLV: 400 ppm; 1440 mg/m3 A4 (ACGIH 1997).


NIOSH REL: TWA 400 ppm (1400 mg/m3)

NIOSH IDLH: 2000 ppm LEL

Exposure effects

Chronic inhalation may cause effects similar to those of acute

inhalation. Chronic exposure may produce anemia, leukocytosis,

cloudy swelling, and fatty degeneration of the viscera.

Ingestion May cause irritation of the digestive tract. May cause liver

damage. May cause headache, drowsiness, and unconsciousness.

Inhalation

Causes respiratory tract irritation. Inhalation of high

concentrations may cause narcotic effects. Exposure may cause

blood abnormalities

Skin May cause skin irritation. Prolonged and/or repeated contact may

cause irritation and/or dermatitis.

First aid

Ingestion

If victim is conscious and alert, give 2-4 cupfuls of milk or

water. Never give anything by mouth to an unconscious person.

Get medical aid immediately.

Inhalation

Remove from exposure to fresh air immediately. If not

breathing, give artificial respiration. If breathing is difficult, give

oxygen. Get medical aid.

Skin

Get medical aid. Flush skin with plenty of soap and water for at

least 15 minutes while removing contaminated clothing and

shoes.

Transport.

UN number 1173

Response guide 129

Hazard class 3

A- 42

Packing Group II

USCG CHRIS Code ETA

USCG

Compatatibility

Group

34 Esters

A- 43

Isopropanol

• 2-Propanol

• Isopropyl alcohol

• Propan-2-ol

Formula CH3CH(OH)CH3 (C3H8O)

Structure

Description Colorless liquid with a sharp, musty odor of rubbing alcohol.

Uses Microbiocide, Solvent.


CAS 67-63-0

EC



EC Class Highly flammable; Irritant; Vapours may cause drowsiness and

dizziness

EC Risk Phrase R 11-36-67

EC Safety Phrase S 7-16-24/25-26

ENCS (MITI) 2-207X

RTECS NT8050000

RTECS class

Agricultural Chemical and Pesticide (A); Tumorigen (C); Drug (D);

Mutagen (M); Reproductive Effector (T); Human Data (P); Primary

Irritant (S)

UN (DOT) 1219

Merck 13,5228





Properties.

Formula mass 60.10

A- 44





Critical temperature 235


Density 0.786 g/cm3

Solubility in water Miscible

Viscosity 2.08 cp (25 °C)

Surface tension 21.19 dyne/cm (25 °C)



0.05

Heat of fusion 21.37 cal/g

Heat of vaporization 28.27 kJ/mol (161 °C)

Heat of combustion -7942 cal/g

Odor threshold 90 mg/m3


Storage Keep away from sources of ignition. Store in a cool, dry place. Store in

a tightly closed container.

WHMIS

B2 - Flammable and combustible material - Flammable liquid D2A -

Poisonous and infectious material - Other effects - Very toxic D2B -

Poisonous and infectious material - Other effects - Toxic

Handling

Wash thoroughly after handling. Wash hands before eating. Use only in

a well ventilated area. Use spark-proof tools and explosion proof

equipment. Empty containers retain product residue, (liquid and/or

vapor), and can be dangerous. Do not get on skin or in eyes. Avoid

ingestion and inhalation. Do not pressurize, cut, weld, braze, solder,

drill, grind, or expose empty containers to heat, sparks or open flames.


Respirators

Follow the OSHA respirator regulations found in 29CFR 1910.134 or



Small spills/leaks Absorb spill with inert material, (e.g., dry sand or earth), then place

into a chemical waste container. Clean up spills immediately, using the

A- 45

appropriate protective equipment. Scoop up with a nonsparking tool,

then place into a suitable container for disposal. Remove all sources of

ignition.

Disposal code 1

Stability

Stable at room temperature in closed containers under normal storage

and handling conditions. This material may be sensitive to peroxide

formation.

Incompatibilities

Oxidizing agents, aldehydes, acetaldeyde, chlorine, ethylene oxide,

acids and isocyanates, hydrogen + palladium, nitroform, oleum,

phosgene, potassium t-butoxide, oxygen, trinitromethane, barium

perchlorate, tetrafluoroborate, nitric acid, halogen and halogen

compounds, chromium trioxide, sodium dichromate + sulfuric acid,

aluminum, and aluminum triisopropoxide. It has also been reported to

be susceptible to autoxidation and should therRefer to therefore be

considered peroxidizable. NFPA manual for more specific information.

Decomposition Carbon monoxide, carbon dioxide.

Fire.

Flash Point,°C 12


Upper exp. limit, % 12.7

Lower exp. limit, % 2

Fire fighting

Use water in flooding quantities as fog. Use foam, dry chemical, or

carbon dioxide. Cool all affected containers with flooding quantities

of water. Apply water from as far a distance as possible. Use water

spray to knock-down vapors. Keep run-off water out of sewers and

water sources.

Fire potential HIGHLY FLAMMABLE.

Hazards

Vapors may form explosive mixtures with air. Vapors may travel to

source of ignition and flash back. Most vapors are heavier than air.

They will spread along ground and collect in low or confined areas

(sewers, basements, tanks). Vapor explosion hazard indoors,

outdoors or in sewers. May polymerize explosively when heated or

involved in a fire. Runoff to sewer may create fire or explosion

hazard. Containers may explode when heated. Many liquids are

lighter than water.

Combustion products Fire may produce irritating, corrosive and/or toxic gases.

NFPA Health 1

A- 46

Flammability 3

Reactivity 0

Special -

Health.

Exposure limit(s)


NIOSH REL: TWA 400 ppm (980 mg/m3) ST 500 ppm (1225

mg/m3)

NIOSH IDLH: 2000 ppm LEL

Exposure effects Prolonged or repeated skin contact may cause defatting and

dermatitis. May cause allergic skin reaction in some individuals.

Ingestion

May cause gastrointestinal irritation with nausea, vomiting and

diarrhea. May cause kidney damage. May cause central nervous

system depression, characterized by excitement, followed by

headache, dizziness, drowsiness, and nausea. Advanced stages

may cause collapse, unconsciousness, coma and possible death

due to respiratory failure.

Inhalation

Inhalation of high concentrations may cause central nervous

system effects characterized by headache, dizziness,

unconsciousness and coma. Inhalation of vapor may cause

respiratory tract irritation. May cause narcotic effects.

Skin

May cause skin sensitization, an allergic reaction, which

becomes evident upon re-exposure to this material. Prolonged

and/or repeated contact may cause defatting of the skin and

dermatitis. May cause irritation with pain and stinging,

especially if the skin is abraded.

First aid

Ingestion


water. Never give anything by mouth to an unconscious person.

Get medical aid immediately. Induce vomiting by giving one

teaspoon of Syrup of Ipecac.

Inhalation

Get medical aid immediately. Remove from exposure to fresh air

immediately. If not breathing, give artificial respiration. If

breathing is difficult, give oxygen.

Skin Get medical aid if irritation develops or persists. Flush skin with

plenty of soap and water.

Transport.

UN number 1219

A- 47

Response guide 129

Hazard class 3

Packing Group II

USCG CHRIS Code IPA

USCG

Compatatibility

Group

20 Alcohols, Glycols

A- 48

Methyl alcohol

• Methanol

• Wood alcohol

• Columbian spirits

• Carbinol

Formula CH3OH (CH4O)

Structure

Description Colorless liquid, with a mild, characteristic alcohol odor, when pure.

Uses

Industrial solvent, raw material for formaldehyde, methyl esters, organic &

inorg acids, antifreeze, fuel, extractant for animal & vegetable oils, to

denature ethanol, manufacture pharmaceuticals, solvent in manufacture of

streptomycin, vitamins, hormones, polymers, plastics.


CAS 67-56-1

EC


EC Index Number 603-001-00-X

EC Class Highly flammable; Toxic

EC Risk Phrase R 11-23/24/25-39/23/24/25

EC Safety Phrase S 7-16-36/37-45

ENCS (MITI) 2-201

RTECS PC1400000

RTECS class Drug (D); Mutagen (M); Reproductive Effector (T); Human Data (P);

Primary Irritant (S)

RCRA U154

UN (DOT) 1230

Merck 13,5984





Properties.

A- 49

Formula mass 32.04

Melting point, °C -98




Critical temperature 240.0 °C


Density 0.7918 g/cm3 (20 °C)

Solubility in water Miscible

Viscosity 0.614 MPa sec

Surface tension 22.61 dynes/cm (at 20°C)



-0.77

Heat of fusion 23.70 cal/g

Heat of vaporization 39.2 kj/mole

Heat of combustion -723 kj/mole

Odor threshold 2,000 ppm


Storage Keep away from sources of ignition. Store in a cool, dry place. Store in

a tightly closed container. Flammables-area.

WHMIS

B2 - Flammable and combustible material - Flammable liquid D1B -

Poisonous and infectious material - Immediate and serious effects -

Toxic D2A - Poisonous and infectious material - Other effects - Very

toxic D2B - Poisonous and infectious material - Other effects - Toxic

Handling

Use spark-proof tools and explosion proof equipment. Avoid breathing

dust, vapor, mist, or gas. Avoid contact with skin and eyes. Use only in

a chemical fume hood.

Protection

Eyes: Wear appropriate protective eyeglasses or chemical safety

goggles as described by OSHA's eye and face protection regulations in

29 CFR 1910.133 or European Standard EN166. Skin: Wear

appropriate protective gloves to prevent skin exposure. Clothing: Wear

appropriate protective clothing to prevent skin exposure.

Respirators Follow the OSHA respirator regulations found in 29CFR 1910.134 or


A- 50


Small spills/leaks Absorb spill with inert material, (e.g., dry sand or earth), then place

into a chemical waste container. Remove all sources of ignition.

Disposal code 1

Stability Stable at room temperature in closed containers under normal storage

and handling conditions.

Incompatibilities

Reducing agents, acid chlorides, active metals, alkali metals, liquid

chlorine, magnesium, sodium hypochlorite, potassium, chloroform,

acids (mineral, oxidizing, e.g. chromic acid, hypochlorous acid, nitric

acid, sulfuric acid), oxidizing agents (strong, e.g. bromine, hydrogen

peroxide, nitrogen dioxide, potassium nitrate), acid anhydrides,

cyanuric chloride, diethyl zinc, perchloric acid, potassium-tert-

butoxide.

Decomposition Carbon monoxide, carbon dioxide, formaldehyde.

Other hazards Corrosive to lead and aluminum.

Fire.

Flash Point,°C 11


Upper exp. limit, % 36

Lower exp. limit, % 7.3

Fire fighting

Wear a self-contained breathing apparatus in pressure-demand,

MSHA/NIOSH (approved or equivalent), and full protective gear.

Vapors can travel to a source of ignition and flash back. Will burn if

involved in a fire. To extinguish fire, use water fog, dry chemical,

carbon dioxide, or regular foam.

Fire potential

Quite flammable, combustion probable. Will burn, may be ignited

by heat, sparks and flames. Flammable vapor may spread away

from spill. Container may explode in heat of fire. Flashback upon

vapor trail may occur.

Hazards Containers may explode.

Combustion products Fire will produce irritating, corrosive and/or toxic gases.

NFPA Health 1

Flammability 3

Reactivity 0

A- 51

Special -

Health.

Exposure limit(s)


NIOSH REL: TWA 200 ppm (260 mg/m3) ST 250 ppm (325

mg/m3) skin

NIOSH IDLH: 6000 ppm

Exposure effects

Prolonged or repeated skin contact may cause dermatitis.

Chronic inhalation and ingestion may cause effects similar to

those of acute inhalation and ingestion.

Ingestion

Cannot be made non-poisonous. May cause irritation of the

digestive tract. Poison by ingestion. May cause respiratory

failure. May cause vascular collapse and damage. May cause

kidney failure. Ingestion can cause blurred vision, narrowing of

the visual field, or blindness.

Inhalation

May cause respiratory tract irritation. May cause adverse central

nervous system effects including headache, convulsions, and

possible death. May cause visual impairment and possible

permanent blindness. May cause effects similar to those

described for ingestion. Toxic if inhaled.

Skin May cause skin irritation. May be harmful if absorbed through

the skin.

First aid

Ingestion


water. Get medical aid immediately. Induce vomiting by giving

one teaspoon of Syrup of Ipecac.

Inhalation


immediately. If not breathing, give artificial respiration. If

breathing is difficult, give oxygen.

Skin

Get medical aid. Flush skin with plenty of soap and water for at

least 15 minutes while removing contaminated clothing and

shoes.

Transport.

UN number 1230

Response guide 131

Hazard class 3

Packing Group II

A- 52

USCG CHRIS Code MAL

USCG

Compatatibility

Group

20 Alcohols, Glycols

A- 53

Material Safety Data Sheet Cyclohexane MSDS Section 1: Chemical Product and Company Identification Product Name: Cyclohexane Catalog Codes: SLC3520, SLC2305 CAS#: 110-82-7 RTECS: GU6300000 TSCA: TSCA 8(b) inventory: Cyclohexane CI#: Not applicable. Synonym: Benzene, hexahydro-; Hexahydrobenzene; Hexamethylene; Hexanaphthene Chemical Name: Cyclohexane Chemical Formula: C6-H12 Contact Information: Sciencelab.com, Inc.

14025 Smith Rd. Houston, Texas 77396 US Sales: 1-800-901-7247 International Sales: 1-281-441-4400 Order Online: ScienceLab.com CHEMTREC (24HR Emergency Telephone), call: 1-800-424-9300 International CHEMTREC, call: 1-703-527-3887 For non-emergency assistance, call: 1-281-441-4400 Section 2: Composition and Information on Ingredients Composition: Name CAS # % by Weight

Cyclohexane 110-82-7 100 Toxicological Data on Ingredients: Cyclohexane: ORAL (LD50): Acute: 12705 mg/kg [Rat]. 813 mg/kg [Mouse]. DERMAL (LD): Acute: >18000 mg/kg [Rabbit]. Section 3: Hazards Identification Potential Acute Health Effects: Slightly hazardous in case of skin contact (irritant, permeator), of eye contact (irritant), of ingestion, of inhalation. Potential Chronic Health Effects: CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. The substance may be toxic to kidneys, liver, cardiovascular system, central nervous system (CNS). Repeated or prolonged exposure to the substance can produce target organs damage. Section 4: First Aid Measures Eye Contact: p. 2 Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelids open. Get medical attention. Skin Contact: In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminated clothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention. Serious Skin Contact: Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek medical attention. Inhalation:

A- 54

If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention. Serious Inhalation: Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek medical attention. Ingestion:

If swallowed, do NOT induce vomiting. Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Aspiration hazard if swallowed- can enter lungs and cause damage. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention. Get medical attention if symptoms appear. Serious Ingestion: Not available. Section 5: Fire and Explosion Data Flammability of the Product: Flammable. Auto-Ignition Temperature: 245°C (473°F) Flash Points: CLOSED CUP: -18°C (-0.4°F). (Setaflash) Flammable Limits: LOWER: 1.3% UPPER: 8.4% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Slightly explosive in presence of open flames and sparks. Fire Fighting Media and Instructions:

Flammable liquid, insoluble in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray or fog. Special Remarks on Fire Hazards: Vapor may travel considerable distance to source of ignition and flash back. Special Remarks on Explosion Hazards: When mixed hot with liquid dinitrogen tetraoxide an explosion can result. Section 6: Accidental Release Measures Small Spill: Absorb with an inert material and put the spilled material in an appropriate waste disposal. Large Spill: Flammable liquid, insoluble in water. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk. Absorb with DRY earth, sand or other non-combustible material. Do not get water inside container. Do not touch spilled material. Prevent entry into sewers, basements or confined areas; dike if needed. Call for assistance on disposal. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDS and with local authorities. Section 7: Handling and Storage p. 3 Precautions: Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents. Storage:

A- 55

Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame). Section 8: Exposure Controls/Personal Protection Engineering Controls: Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respective threshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location. Personal Protection: Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves. Personal Protection in Case of a Large Spill:

Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product. Exposure Limits: TWA: 300 (ppm) from ACGIH (TLV) [United States] TWA: 300 (ppm) from OSHA (PEL) [United States] TWA: 1050 (mg/m3) from OSHA (PEL) [United States] TWA: 100 STEL: 300 (ppm) [United Kingdom (UK)] TWA: 350 STEL: 1050 (mg/m3) [United Kingdom (UK)]Consult local authorities for acceptable exposure limits. Section 9: Physical and Chemical Properties Physical state and appearance: Liquid. Odor: Chloroform-like odor; solvent odor; mild sweet odor Taste: Not available. Molecular Weight: 84.16 g/mole Color: Clear Colorless. pH (1% soln/water): Not applicable. Boiling Point: 80.7°C (177.3°F) Melting Point: 6.47°C (43.6°F) Critical Temperature: 280.4°C (536.7°F) Specific Gravity: 0.7781 (Water = 1) Vapor Pressure: 12.9 kPa (@ 20°C) Vapor Density: 2.98 (Air = 1) Volatility: Not available. Odor Threshold: 25 ppm Water/Oil Dist. Coeff.: The product is more soluble in oil; log(oil/water) = 3.4 Ionicity (in Water): Not available. p. 4 Dispersion Properties: See solubility in water, methanol. Solubility: Soluble in methanol. Insoluble in cold water. Section 10: Stability and Reactivity Data Stability: The product is stable. Instability Temperature: Not available. Conditions of Instability: Heat, ignition sources, incompatible materials Incompatibility with various substances: Reactive with oxidizing agents. Corrosivity: Not considered to be corrosive for metals and glass. Special Remarks on Reactivity: Not available. Special Remarks on Corrosivity: Not available. Polymerization: Will not occur. Section 11: Toxicological Information Routes of Entry: Absorbed through skin. Eye contact. Inhalation. Ingestion. Toxicity to Animals: Acute oral toxicity (LD50): 813 mg/kg [Mouse].

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Chronic Effects on Humans: May cause damage to the following organs: kidneys, liver, cardiovascular system, central nervous system (CNS). Other Toxic Effects on Humans: Slightly hazardous in case of skin contact (irritant, permeator), of ingestion, of inhalation. Special Remarks on Toxicity to Animals: Lowest Published Lethal Dose: LCL[Mouse] - Route: Inhalation; Dose: 70000 mg/m3/2H LCL[Rabbit] - 89600 mg/m3/1H Special Remarks on Chronic Effects on Humans: Human: passes the placental barrier, detected in maternal milk. May affect genetic material (mutagenic) Special Remarks on other Toxic Effects on Humans: Acute Potential Health Effects: Skin: It may cause skin irritation. It may be absorbed through the skin. Eyes: It may cause eye irritation. Inhalation: It may cause respiratory tract (nose, throat) irritation. Exposure to high concentrations of vapor may cause nausea, increased respiration rate. It may also affect behavior/central nervous system(dizziness, lethargy, somnolence, lightheadedness, seizures/convulsions, weakness, loss of coordination and judgement, trembling, drowsiness). Unconsciousness and death may occur at high exposures. In experimental animals there is a narrow margin between doses causing narcosis, loss of reflexes and death. Generalized vascular damage/collapse and degenerative changes were seen in the heart, lung, liver kidneys and brain of experimental animals exposed to lethal concentrations by inhalation or ingestion. Ingestion: May cause gastrointestinal irritation and diarrhea. May affect behavior/central nervous system with symptoms similar that that of inhalation. May cause liver and kidney damage. Aspiration of cyclohexane into the lungs may cause chemical pneumonitis. Chronic Potential Health Effects: Skin: Prolonged or repeated skin contact may cause drying, cracking and chapping of exposed areas. Ingestion and Ingestion: Prolonged or repeated inhalation or ingestion may causeliver and kidney damage. It may also affect behavior/central nevous system with symtoms similar to that of acute ingestion or inhalation. Section 12: Ecological Information Ecotoxicity: Not available. BOD5 and COD: Not available. Products of Biodegradation:

p. 5 Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise. Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic. Special Remarks on the Products of Biodegradation: Not available. Section 13: Disposal Considerations Waste Disposal: Waste must be disposed of in accordance with federal, state and local environmental control regulations. Section 14: Transport Information DOT Classification: CLASS 3: Flammable liquid. Identification: : Cyclohexane UNNA: 1145 PG: II Special Provisions for Transport: Not available. Section 15: Other Regulatory Information Federal and State Regulations: Connecticut hazardous material survey.: Cyclohexane Illinois toxic substances disclosure to employee act: Cyclohexane

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Illinois chemical safety act: Cyclohexane New York release reporting list: Cyclohexane Rhode Island RTK hazardous substances: Cyclohexane Pennsylvania RTK: Cyclohexane Minnesota: Cyclohexane Massachusetts RTK: Cyclohexane Massachusetts spill list: Cyclohexane New Jersey: Cyclohexane New Jersey spill list: Cyclohexane Louisiana spill reporting: Cyclohexane TSCA 8(b) inventory: Cyclohexane SARA 313 toxic chemical notification and release reporting: Cyclohexane CERCLA: Hazardous substances.: Cyclohexane: 1000 lbs. (453.6 kg) Other Regulations:

OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances. Other Classifications: WHMIS (Canada): CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F). DSCL (EEC): HMIS (U.S.A.): Health Hazard: 1 Fire Hazard: 3 Reactivity: 0 Personal Protection: h National Fire Protection Association (U.S.A.): Health: 1 Flammability: 3 Reactivity: 0 Specific hazard: Protective Equipment:

Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respirator when ventilation is inadequate. Splash goggles. p. 6 Section 16: Other Information References: Not available. Other Special Considerations: Not available. Created: 10/10/2005 08:17 PM Last Updated: 05/21/2013 12:00 PM The information above is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.com has been advised of the possibility of such damages.

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Material Safety Data Sheet Ethanethiol MSDS Section 1: Chemical Product and Company Identification Product Name: Ethanethiol Catalog Codes: SLE1348 CAS#: 75-08-1 RTECS: KI9625000 TSCA: TSCA 8(b) inventory: Ethanethiol CI#: Not available. Synonym: Ethyl Mercaptan Chemical Formula: C2H6S Contact Information: Sciencelab.com, Inc. 14025 Smith Rd. Houston, Texas 77396 US Sales: 1-800-901-7247 International Sales: 1-281-441-4400 Order Online: ScienceLab.com CHEMTREC (24HR Emergency Telephone), call: 1-800-424-9300 International CHEMTREC, call: 1-703-527-3887 For non-emergency assistance, call: 1-281-441-4400 Section 2: Composition and Information on Ingredients Composition: Name CAS # % by Weight

Ethanethiol 75-08-1 100 Toxicological Data on Ingredients: Ethanethiol: ORAL (LD50): Acute: 1034 mg/kg [Rat]. 1500 mg/kg [Mouse]. VAPOR (LC50): Acute: 2770 ppm 4 hour(s) [Mouse]. 4420 ppm 4 hour(s) [Rat]. Section 3: Hazards Identification Potential Acute Health Effects: Extremely hazardous in case of skin contact (irritant). Very hazardous in case of eye contact (irritant), of inhalation (lung irritant). Hazardous in case of skin contact (permeator), of ingestion, . Slightly hazardous in case of skin contact (corrosive, sensitizer). Inflammation of the eye is characterized by redness, watering, and itching. Skin inflammation is characterized by itching, scaling, reddening, or, occasionally, blistering. Potential Chronic Health Effects: CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. Repeated or prolonged exposure is not known to aggravate medical condition. Section 4: First Aid Measures Eye Contact:

p. 2 Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelids open. Cold water may be used. Do not use an eye ointment. Seek medical attention. Skin Contact:

After contact with skin, wash immediately with plenty of water. Gently and thoroughly wash the contaminated skin with running water and non-abrasive soap. Be particularly careful to clean folds, crevices, creases and groin. Cover the irritated skin with an emollient. If irritation persists, seek medical attention. Wash contaminated clothing before reusing. Serious Skin Contact: Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medical

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attention. Inhalation: Allow the victim to rest in a well ventilated area. Seek immediate medical attention. Serious Inhalation: Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. WARNING: It may be hazardous to the person providing aid to give mouth-to-mouth resuscitation when the inhaled material is toxic, infectious or corrosive. Seek medical attention. Ingestion: Do not induce vomiting. Examine the lips and mouth to ascertain whether the tissues are damaged, a possible indication that the toxic material was ingested; the absence of such signs, however, is not conclusive. Loosen tight clothing such as a collar, tie, belt or waistband. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek immediate medical attention. Serious Ingestion: Not available. Section 5: Fire and Explosion Data Flammability of the Product: Flammable. Auto-Ignition Temperature: 299°C (570.2°F) Flash Points: CLOSED CUP: 4.83°C (40.7°F). OPEN CUP: -53.7°C (-64.7°F). Flammable Limits: LOWER: 2.8% UPPER: 18.2% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Flammable in presence of open flames and sparks, of heat, of oxidizing materials. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product in presence of static discharge: Not available. Fire Fighting Media and Instructions:

Flammable liquid, soluble or dispersed in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use alcohol foam, water spray or fog. Special Remarks on Fire Hazards: Not available. Special Remarks on Explosion Hazards: Not available. Section 6: Accidental Release Measures Small Spill: Absorb with an inert material and put the spilled material in an appropriate waste disposal. Large Spill: Flammable liquid. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk. Absorb with DRY earth, sand or other non-combustible material. Do not touch spilled material. Prevent entry into sewers, basements or confined areas; dike if needed. Eliminate all ignition sources. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDS and with local authorities. p. 3 Section 7: Handling and Storage Precautions: Keep container dry. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapour/spray. Never add water to this product In case of insufficient ventilation, wear suitable respiratory equipment If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes Storage:

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Flammable materials should be stored in a separate safety storage cabinet or room. Keep away from heat. Keep away from sources of ignition. Keep container tightly closed. Keep in a cool, well-ventilated place. Ground all equipment containing material. A refrigerated room would be preferable for materials with a flash point lower than 37.8°C (100°F). Section 8: Exposure Controls/Personal Protection Engineering Controls:

Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respective threshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location. Personal Protection:

Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves. Personal Protection in Case of a Large Spill: Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product. Exposure Limits: TWA: 0.5 CEIL: 2 (ppm) TWA: 1 CEIL: 3 (mg/m3) Consult local authorities for acceptable exposure limits. Section 9: Physical and Chemical Properties Physical state and appearance: Liquid. Odor: Stench. (Strong.) Taste: Not available. Molecular Weight: 62.13 g/mole Color: Colorless to light yellow. pH (1% soln/water): Not available. Boiling Point: 34.95°C (94.9°F) Melting Point: -144.4°C (-227.9°F) Critical Temperature: Not available. Specific Gravity: 0.8391 (Water = 1) Vapor Pressure: 442 mm of Hg (@ 20°C) Vapor Density: 2.14 (Air = 1) Volatility: Not available. Odor Threshold: 0.002 ppm Water/Oil Dist. Coeff.: Not available. Ionicity (in Water): Not available. p. 4 Dispersion Properties: Not available. Solubility: Very slightly soluble in cold water. Section 10: Stability and Reactivity Data Stability: The product is stable. Instability Temperature: Not available. Conditions of Instability: Not available. Incompatibility with various substances: Not available. Corrosivity: Not available. Special Remarks on Reactivity: Not available. Special Remarks on Corrosivity: Not available. Polymerization: No. Section 11: Toxicological Information Routes of Entry: Dermal contact. Eye contact. Inhalation. Ingestion. Toxicity to Animals: WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oral toxicity (LD50): 1034 mg/kg [Rat]. Acute toxicity of the vapor (LC50): 2770 ppm 4 hour(s) [Mouse].

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Chronic Effects on Humans: Not available. Other Toxic Effects on Humans: Extremely hazardous in case of skin contact (irritant). Very hazardous in case of inhalation (lung irritant). Hazardous in case of skin contact (permeator), of ingestion, . Slightly hazardous in case of skin contact (corrosive, sensitizer). Special Remarks on Toxicity to Animals: Not available. Special Remarks on Chronic Effects on Humans: Not available. Special Remarks on other Toxic Effects on Humans: Not available. Section 12: Ecological Information Ecotoxicity: Not available. BOD5 and COD: Not available. Products of Biodegradation:

Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise. Toxicity of the Products of Biodegradation: The products of degradation are more toxic. Special Remarks on the Products of Biodegradation: Not available. Section 13: Disposal Considerations Waste Disposal:

Section 14: Transport Information p. 5 DOT Classification: Class 3: Flammable liquid. Identification: : Ethyl Mercaptan : UN2363 PG: I Special Provisions for Transport: Not available. Section 15: Other Regulatory Information Federal and State Regulations:

Rhode Island RTK hazardous substances: Ethanethiol Pennsylvania RTK: Ethanethiol Florida: Ethanethiol Minnesota: Ethanethiol Massachusetts RTK: Ethanethiol New Jersey: Ethanethiol TSCA 8(b) inventory: Ethanethiol Other Regulations: OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). Other Classifications: WHMIS (Canada): CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F). CLASS D-1A: Material causing immediate and serious toxic effects (VERY TOXIC). DSCL (EEC):

R11- Highly flammable. R20- Harmful by inhalation. R37/38- Irritating to respiratory system and skin. R41- Risk of serious damage to eyes. HMIS (U.S.A.): Health Hazard: 2 Fire Hazard: 4 Reactivity: 0 Personal Protection: h National Fire Protection Association (U.S.A.): Health: 2 Flammability: 4 Reactivity: 0 Specific hazard: Protective Equipment: Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respirator when ventilation is inadequate. Splash goggles. Section 16: Other Information Other Special Considerations: Not available. Created: 10/09/2005 05:27 PM Last Updated: 05/21/2013 12:00 PM

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Material Safety Data Sheet Ethyl acetate MSDS Section 1: Chemical Product and Company Identification Product Name: Ethyl acetate Catalog Codes: SLE2452, SLE2317 CAS#: 141-78-6 RTECS: AH5425000 TSCA: TSCA 8(b) inventory: Ethyl acetate CI#: Not available. Synonym: Acetic Acid, Ethyl Ester Acetic Ether Chemical Name: Ethyl Acetate Chemical Formula: C4-H8-O2 Contact Information: Sciencelab.com, Inc. 14025 Smith Rd. Houston, Texas 77396 US Sales: 1-800-901-7247 International Sales: 1-281-441-4400 Order Online: ScienceLab.com CHEMTREC (24HR Emergency Telephone), call:

1-800-424-9300 International CHEMTREC, call: 1-703-527-3887 For non-emergency assistance, call: 1-281-441-4400 Section 2: Composition and Information on Ingredients Composition: Name CAS # % by Weight Ethyl acetate 141-78-6 100 Toxicological Data on Ingredients: Ethyl acetate: ORAL (LD50): Acute: 5620 mg/kg [Rat]. 4100 mg/kg [Mouse]. 4935 mg/kg [Rabbit]. VAPOR (LC50): Acute: 45000 mg/m 3 hours [Mouse]. 16000 ppm 6 hours [Rat]. Section 3: Hazards Identification Potential Acute Health Effects: Hazardous in case of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant, permeator), of eye contact (irritant). Potential Chronic Health Effects: CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. The substance is toxic to mucous membranes, upper respiratory tract. The substance may be toxic to blood, kidneys, liver, central nervous system (CNS). Repeated or prolonged exposure to the substance can produce target organs damage. Section 4: First Aid Measures p. 2 Eye Contact: Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Cold water may be used. Get medical attention. Skin Contact:

Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops. Cold water may be used. Serious Skin Contact: Not available. Inhalation:

If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention if symptoms appear.

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Serious Inhalation: Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek medical attention. Ingestion: Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if symptoms appear. Serious Ingestion: Not available. Section 5: Fire and Explosion Data Flammability of the Product: Flammable. Auto-Ignition Temperature: 426.67°C (800°F) Flash Points: CLOSED CUP: -4.4°C (24.1°F). (TAG) OPEN CUP: 7.2°C (45°F) (Cleveland). Flammable Limits: LOWER: 2.2% UPPER: 9% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat. Slightly flammable to flammable in presence of oxidizing materials, of acids, of alkalis. Non-flammable in presence of shocks. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of static discharge: Not available. Slightly explosive in presence of heat. Nonexplosive in presence of shocks. Fire Fighting Media and Instructions: Flammable liquid, soluble or dispersed in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use alcohol foam, water spray or fog. Special Remarks on Fire Hazards: Vapor may travel considerable distance to source of ignition and flash back. When heated to decomposition it emits acrid smoke and irritating fumes. Special Remarks on Explosion Hazards:

The liquid produces a vapor that forms explosive mixtures with air at normal temperatures. Explosive reaction with lithium tetrahydroaluminate. Section 6: Accidental Release Measures Small Spill: Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal container. p. 3 Large Spill: Flammable liquid. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk. Absorb with DRY earth, sand or other non-combustible material. Do not touch spilled material. Prevent entry into sewers, basements or confined areas; dike if needed. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDS and with local authorities. Section 7: Handling and Storage Precautions: Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Keep away from incompatibles such as oxidizing agents, acids, alkalis.

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Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame). Moisture sensitive. Section 8: Exposure Controls/Personal Protection Engineering Controls: Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respective threshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location. Personal Protection: Safety glasses. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves. Personal Protection in Case of a Large Spill: Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product. Exposure Limits:

TWA: 400 (ppm) from OSHA (PEL) [United States] TWA: 400 from ACGIH (TLV) [United States] TWA: 1400 (mg/m3) from NIOSH [United States] TWA: 400 (ppm) from NIOSH [United States] TWA: 400 (ppm) [Canada] TWA: 1440 (mg/m3) [Canada] TWA: 1400 (mg/m3) from OSHA (PEL) [United States]3 Consult local authorities for acceptable exposure limits. Section 9: Physical and Chemical Properties Physical state and appearance: Liquid. Odor: Ethereal. Fruity. (Slight.) Taste: Bittersweet, wine-like burning taste Molecular Weight: 88.11 g/mole Color: Colorless. pH (1% soln/water): Not available. Boiling Point: 77°C (170.6°F) Melting Point: -83°C (-117.4°F) Critical Temperature: 250°C (482°F) Specific Gravity: 0.902 (Water = 1) Vapor Pressure: 12.4 kPa (@ 20°C) p. 4 Vapor Density: 3.04 (Air = 1) Volatility: Not available. Odor Threshold: 3.9 ppm Water/Oil Dist. Coeff.: The product is more soluble in oil; log(oil/water) = 0.7 Ionicity (in Water): Not available. Dispersion Properties: See solubility in water, diethyl ether, acetone. Solubility: Soluble in cold water, hot water, diethyl ether, acetone, alcohol, benzene. Section 10: Stability and Reactivity Data Stability: The product is stable. Instability Temperature: Not available. Conditions of Instability: Heat, ignition sources (flames, sparks, static), incompatible materials Incompatibility with various substances: Reactive with oxidizing agents, acids, alkalis. Corrosivity: Non-corrosive in presence of glass. Special Remarks on Reactivity: Also incompatible with nitrates, chlorosulfonic acid, oleum, potassium-tert-butoxide, and lithium tetrahydroaluminate. Moisture sensitive. On storage, it is slowly decomposed by water. Special Remarks on Corrosivity: Not available. Polymerization: Will not occur. Section 11: Toxicological Information

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Routes of Entry: Absorbed through skin. Eye contact. Inhalation. Ingestion. Toxicity to Animals: WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oral toxicity (LD50): 4100 mg/kg [Mouse]. Acute toxicity of the vapor (LC50): 45000 mg/m3 3 hours [Mouse]. Chronic Effects on Humans: CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH. Causes damage to the following organs: mucous membranes, upper respiratory tract. May cause damage to the following organs: blood, kidneys, liver, central nervous system (CNS). Other Toxic Effects on Humans: Hazardous in case of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant, permeator). Special Remarks on Toxicity to Animals: LD50 [Rabbit] - Route: skin; Dose >20,000 ml/kg Special Remarks on Chronic Effects on Humans:

May affect genetic material (mutagenic). May cause adverse reproductive effects. based on animal test data. No human data found at this time. Special Remarks on other Toxic Effects on Humans: Acute Potential Health Effects: Skin: May cause skin irritation. Eyes: Causes eye irritation. May cause irritation of the conjunctivia. Inhalation: May cause respiratory tract and mucous membrane irritation. May affect respiration and may cause acute pulmonary edema. May affect gastrointestinal tract (nausea, vomiting). May affect behavior/central nervous system (mild central nervous system depression - exhilaration, talkativeness, boastfulness, belligerancy, vertigo, diplopia, drowsiness, slurred speech, slowed reaction time, dizziness, lightheadedness, somnolence, ataxia, unconciousness, irritability, fatigue, sleep disturbances, reduced memory and concentration, stupor, coma), cardiovascular system (peripheral vascular collapse (shock) - rapid pulse, hypotension, cold pale skin, hypothermia). Other symptoms may include: flushing of face and sweating. p. 5 Ingestion: May cause gastrointestinal tract irritation with nausea and vomiting. May affect blood, behavior/central nervous system (CNS depression - effects may be similar to that of inhalation). Chronic Potential Health Effects: Skin: Repeated or prolonged skin contact may cause drying and cracking of the skin. IngestIon: Prolonged or repeated ingestion may affect the liver. Inhalation: Prolonged inhalation may affect behavior/central nervous system (symptoms similar to those of acute inhalation), and cause liver, kidney, lung, and heart damage. It may also affect metabolism, and blood (anemia, leukocytosis). Section 12: Ecological Information Ecotoxicity: Ecotoxicity in water (LC50): 220 mg/l 96 hours [Fish (Fathead minnow)]. 212.5 ppm 96 hours [Fish (Indian catfish)]. BOD5 and COD: Not available. Products of Biodegradation:

Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise. Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic. Special Remarks on the Products of Biodegradation: Not available. Section 13: Disposal Considerations Waste Disposal:

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Waste must be disposed of in accordance with federal, state and local environmental control regulations. Section 14: Transport Information DOT Classification: CLASS 3: Flammable liquid. Identification: : Ethyl Acetate UNNA: 1173 PG: II Special Provisions for Transport: Not available. Section 15: Other Regulatory Information Federal and State Regulations:

Connecticut hazardous material survey.: Ethyl acetate Illinois toxic substances disclosure to employee act: Ethyl acetate Illinois chemical safety act: Ethyl acetate New York release reporting list: Ethyl acetate Rhode Island RTK hazardous substances: Ethyl acetate Pennsylvania RTK: Ethyl acetate Florida: Ethyl acetate Minnesota: Ethyl acetate Massachusetts RTK: Ethyl acetate Massachusetts spill list: Ethyl acetate New Jersey: Ethyl acetate New Jersey spill list: Ethyl acetate Louisiana spill reporting: Ethyl acetate California Director's list of Hazardous Substances: Ethyl acetate TSCA 8(b) inventory: Ethyl acetate TSCA 4(a) final test rules: Ethyl acetate TSCA 8(a) IUR: Ethyl acetate TSCA 12(b) annual export notification: Ethyl acetate CERCLA: Hazardous substances.: Ethyl acetate: 5000 lbs. (2268 kg) Other Regulations: OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances. Other Classifications: WHMIS (Canada): CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F). DSCL (EEC): R11- Highly flammable. R36- Irritating to eyes. S2- Keep out of the reach of children. S16- Keep away from sources of ignition - No smoking. S26- In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S33- Take precautionary measures against static discharges. S46- If swallowed, seek medical advice immediately and show this container or label. p. 6 HMIS (U.S.A.): Health Hazard: 2 Fire Hazard: 3 Reactivity: 0 Personal Protection: g National Fire Protection Association (U.S.A.): Health: 1 Flammability: 3 Reactivity: 0 Specific hazard: Protective Equipment:

Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respirator when ventilation is inadequate. Safety glasses. Section 16: Other Information References: Not available. Other Special Considerations: Not available. Created: 10/10/2005 08:18 PM Last Updated: 05/21/2013 12:00 PM

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Material Safety Data Sheet Ethyl Alcohol 190 Proof MSDS Section 1: Chemical Product and Company Identification Product Name: Ethyl Alcohol 190 Proof Catalog Codes: SLE1036, SLE1609, SLE1288 CAS#: Mixture. RTECS: Not applicable. TSCA: TSCA 8(b) inventory: Water; Ethyl alcohol 200 Proof CI#: Not applicable. Synonym: Ethyl Alcohol 190 Proof Chemical Formula: Not applicable. Contact Information: Sciencelab.com, Inc. 14025 Smith Rd. Houston, Texas 77396 US Sales: 1-800-901-7247 International Sales: 1-281-441-4400 Order Online: ScienceLab.com CHEMTREC (24HR Emergency Telephone), call:

1-800-424-9300 International CHEMTREC, call: 1-703-527-3887 For non-emergency assistance, call: 1-281-441-4400 Section 2: Composition and Information on Ingredients Composition: Name CAS # % by Weight Water 7732-18-5 5 Ethyl alcohol 200 Proof 64-17-5 95 Toxicological Data on Ingredients: Ethyl alcohol 200 Proof: ORAL (LD50): Acute: 7060 mg/kg [Rat]. 3450 mg/kg [Mouse]. VAPOR (LC50): Acute: 20000 ppm 8 hours [Rat]. 39000 mg/m 4 hours [Mouse]. Section 3: Hazards Identification Potential Acute Health Effects: Hazardous in case of skin contact (irritant), of eye contact (irritant), . Slightly hazardous in case of skin contact (permeator), of ingestion. Non-corrosive for skin. Non-corrosive to the eyes. Non-corrosive for lungs. Potential Chronic Health Effects:

Slightly hazardous in case of skin contact (sensitizer) CARCINOGENIC EFFECTS: Classified PROVEN by State of California Proposition 65 [Ethyl alcohol 200 Proof]. Classified A4 (Not classifiable for human or animal.) by ACGIH [Ethyl alcohol 200 Proof]. MUTAGENIC EFFECTS: Mutagenic for mammalian somatic cells. [Ethyl alcohol 200 Proof]. Mutagenic for bacteria and/or yeast. [Ethyl alcohol 200 Proof]. TERATOGENIC EFFECTS: Classified PROVEN for human [Ethyl alcohol 200 Proof]. DEVELOPMENTAL TOXICITY: Classified Development toxin [PROVEN] [Ethyl alcohol 200 Proof]. Classified Reproductive system/toxin/female, Reproductive system/toxin/male [POSSIBLE] [Ethyl alcohol 200 Proof]. The substance is toxic to blood, the reproductive system, liver, upper respiratory tract, skin, central nervous p. 2 Section 4: First Aid Measures Eye Contact: Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelids open. Cold water may be used. Get medical attention. Skin Contact:

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In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminated clothing and shoes. Cold water may be used.Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention. Serious Skin Contact: Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek medical attention. Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention if symptoms appear. Serious Inhalation: Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek medical attention. Ingestion: Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if symptoms appear. Serious Ingestion: Not available. Section 5: Fire and Explosion Data Flammability of the Product: Flammable. Auto-Ignition Temperature: The lowest known value is 363°C (685.4°F) (Ethyl alcohol 200 Proof). Flash Points: CLOSED CUP: 18.5°C (65.3°F).(estimated) Flammable Limits: The greatest known range is LOWER: 3.3% UPPER: 19% (Ethyl alcohol 200 Proof) Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances:

Highly flammable in presence of open flames and sparks, of heat. Slightly flammable to flammable in presence of oxidizing materials. Non-flammable in presence of shocks, of reducing materials, of combustible materials, of organic materials, of metals, of acids, of alkalis. Explosion Hazards in Presence of Various Substances: Slightly explosive in presence of open flames and sparks, of heat, of oxidizing materials, of acids. Non-explosive in presence of shocks. Fire Fighting Media and Instructions:

Flammable liquid, soluble or dispersed in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use alcohol foam, water spray or fog. Special Remarks on Fire Hazards: Containers should be grounded. CAUTION: MAY BURN WITH NEAR INVISIBLE FLAME Vapor may travel considerable distance to source of ignition and flash back. May form explosive mixtures with air. Contact with Bromine pentafluoride is likely to cause fire or explosion. Ethanol ignites on contact with chromyl chloride. Ethanol ignites on contact with iodine heptafluoride gas. It ignites than explodes upon contact with nitrosyl perchlorate. Additon of platinum black catalyst caused ignition. (Ethyl alcohol 200 Proof) Special Remarks on Explosion Hazards: Ethanol has an explosive reaction with the oxidized coating around potassium metal. Ethanol ignites and then explodes on contact with acetic anhydride + sodium hydrosulfate (ignites and may explode), disulfuric acid + nitric acid, phosphorous(III)

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p. 3 oxide platinum, potassium-tert-butoxide+ acids. Ethanol forms explosive products in reaction with the following compound : ammonia + silver nitrate (forms silver nitride and silver fulminate), iodine + phosphorus (forms ethane iodide), magnesium perchlorate (forms ethyl perchlorate), mercuric nitrate, nitric acid + silver (forms silver fulminate) silver nitrate (forms ethyl nitrate) silver(I) oxide + ammonia or hydrazine (forms silver nitride and silver fulminate), sodium (evolves hydrogen gas). Sodium Hydrazide + alcohol can produce an explosion. Alcohols should not be mixed with mercuric nitrate, as explosive mercuric fulminate may be formed. May form explosive mixture with manganese perchlorate + 2,2-dimethoxypropane. Addition of alcohols to highly concentrate hydrogen peroxide forms powerful explosives. Explodes on contact with calcium hypochlorite Vapor may explode if ignited in an enclosed area. Containers may explode when heated or involved in a fire. (Ethyl alcohol 200 Proof) Section 6: Accidental Release Measures Small Spill:

Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal container. Large Spill: Flammable liquid. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk. Absorb with DRY earth, sand or other non-combustible material. Do not touch spilled material. Prevent entry into sewers, basements or confined areas; dike if needed. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDS and with local authorities. Section 7: Handling and Storage Precautions: Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents, acids, alkalis, moisture. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame). Do not store above 23°C (73.4°F). Section 8: Exposure Controls/Personal Protection Engineering Controls: Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respective threshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location. Personal Protection: Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves. Personal Protection in Case of a Large Spill:

Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product.

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Exposure Limits: Ethyl alcohol 200 Proof TWA: 1900 (mg/m3) from OSHA (PEL) [United States] TWA: 1000 (ppm) from OSHA (PEL) [United States] TWA: 1900 (mg/m3) from NIOSH [United States] TWA: 1000 (ppm) from NIOSH [United States] TWA: 1000 (ppm) [United Kingdom (UK)] TWA: 1920 (mg/m3) [United Kingdom (UK)] TWA: 1000 STEL: 1250 (ppm) [Canada] Consult local authorities for acceptable exposure limits. Section 9: Physical and Chemical Properties Physical state and appearance: Liquid. p. 4 Odor: Alcohol like. Mild to strong. Like wine or whiskey; Ethereal, vinous. Pleasant. Taste: Burning. Pungent. Molecular Weight: Not applicable. Color: Clear Colorless. pH (1% soln/water): Neutral. Boiling Point: The lowest known value is 78.5°C (173.3°F) (Ethyl alcohol 200 Proof). Weighted average: 79.58°C (175.2°F) Melting Point: May start to solidify at -114.1°C (-173.4°F) based on data for: Ethyl alcohol 200 Proof. Critical Temperature: The lowest known value is 243°C (469.4°F) (Ethyl alcohol 200 Proof). Specific Gravity: Weighted average: 0.8 (Water = 1) Vapor Pressure: The highest known value is 5.7 kPa (@ 20°C) (Ethyl alcohol 200 Proof). Weighted average: 5.53 kPa (@ 20°C) Vapor Density: The highest known value is 1.59 (Air = 1) (Ethyl alcohol 200 Proof). Weighted average: 1.54 (Air = 1) Volatility: Not available. Odor Threshold: 100 ppm Water/Oil Dist. Coeff.: Not available. Ionicity (in Water): Not available. Dispersion Properties: See solubility in water, methanol, diethyl ether, acetone. Solubility: Easily soluble in cold water, hot water, methanol, diethyl ether. Soluble in acetone. Section 10: Stability and Reactivity Data Stability: The product is stable. Instability Temperature: Not available. Conditions of Instability: Incompatible materials, heat, sources of ignition. Incompatibility with various substances: Reactive with oxidizing agents, acids, alkalis. Corrosivity: Non-corrosive in presence of glass. Special Remarks on Reactivity: Ethanol rapidly absorbs moisture from the air. Can react vigorously with oxiders. The following oxidants have been demonstrated to undergo vigorous/explosive reaction with ethanol: barium perchlorate, bromine pentafluoride, calcium hypochlorite, chloryl perchlorate, chromium trioxide, chromyl chloride, dioxygen difluoride, disulfuryl difluoride, fluorine nitrate, hydrogen peroxide, iodine heptafluoride, nitric acid nitrosyl perchlorate, perchloric acid permanganic acid, peroxodisulfuric acid, potassium dioxide, potassium perchlorate, potassium permanganate, ruthenium(VIII) oxide, silver perchlorate, silver peroxide, uranium hexafluoride, uranyl perchlorate. Ethanol reacts violently/expodes with the following compounds: acetyl bromide (evolves hydrogen bromide) acetyl chloride, aluminum, sesquibromide ethylate, ammonium hydroxide & silver oxide, chlorate, chromic anhydride, cyanuric acid + water, dichloromethane + sulfuric acid + nitrate (or) nitrite, hydrogen peroxide + sulfuric acid, iodine + methanol + mercuric oxide, manganese perchlorate + 2,2-dimethoxy propane, perchlorates,

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permanganates + sulfuric acid, potassium superoxide, potassium tert-butoxide, silver & nitric acid, silver perchlorate, sodium hydrazide, sulfuric acid + sodium dichromate, tetrachlorisilane + water. Ethanol is also incompatible with platinium, and sodium. No really safe conditions exist under which ethyl alcohol and chlorine oxides can be handled. Reacts vigorously with acetyl chloride (Ethyl alcohol 200 Proof) Special Remarks on Corrosivity: Not available. Polymerization: Will not occur. p. 5 Section 11: Toxicological Information Routes of Entry: Absorbed through skin. Eye contact. Inhalation. Ingestion. Toxicity to Animals: Acute oral toxicity (LD50): 3632 mg/kg (Mouse) (Calculated value for the mixture). Chronic Effects on Humans:

CARCINOGENIC EFFECTS: Classified PROVEN by State of California Proposition 65 [Ethyl alcohol 200 Proof]. Classified A4 (Not classifiable for human or animal.) by ACGIH [Ethyl alcohol 200 Proof]. MUTAGENIC EFFECTS: Mutagenic for mammalian somatic cells. [Ethyl alcohol 200 Proof]. Mutagenic for bacteria and/or yeast. [Ethyl alcohol 200 Proof]. TERATOGENIC EFFECTS: Classified PROVEN for human [Ethyl alcohol 200 Proof]. DEVELOPMENTAL TOXICITY: Classified Development toxin [PROVEN] [Ethyl alcohol 200 Proof]. Classified Reproductive system/toxin/female, Reproductive system/toxin/male [POSSIBLE] [Ethyl alcohol 200 Proof]. Other Toxic Effects on Humans: Hazardous in case of skin contact (irritant), of inhalation. Slightly hazardous in case of skin contact (permeator), of ingestion. Special Remarks on Toxicity to Animals:

Lowest Published Dose/Conc: LDL[Human] - Route: Oral; Dose: 1400 mg/kg LDL[Human child] - Route: Oral; Dose: 2000 mg/ kg LDL[Rabbit] - Route: Skin; Dose: 20000 mg/kg (Ethyl alcohol 200 Proof) Special Remarks on Chronic Effects on Humans: May affect genetic material (mutagenic) Causes adverse reproductive effects and birth defects (teratogenic) , based on moderate to heavy consumption. May cause cancer based on animal data. Human: passes through the placenta, excreted in maternal milk. (Ethyl alcohol 200 Proof) Special Remarks on other Toxic Effects on Humans:

Acute potential health effects: Skin: causes skin irritation Eyes: causes eye irritation Ingestion: May cause gastrointestinal tract irritation with nausea, vomiting, diarrhea, and alterations in gastric secretions. May affect behavior/central nervous system (central nervous system depression - amnesia, headache, muscular incoordination, excitation, mild euphoria, slurred speech, drowsiness, staggaring gait, fatigue, changes in mood/personality, excessive talking, dizziness, ataxia, somnolence, coma/narcosis, hallucinations, distorted perceptions, general anesthetic), peripherial nervous system (spastic paralysis)vision (diplopia). Moderately toxic and narcotic in high concentrations. May also affect metabolism, blood, liver, respiration (dyspnea), and endocrine system. May affect respiratory tract, cardiovascular(cardiac arrhythmias, hypotension), and urinary systems. Inhalation: May cause irritation of the respiratory tract and affect behavior/central nervous system with symptoms similar to ingestion. Chronic Potential Health Effects: Skin: Prolonged or repeated skin contact may casue dermatitis, an allergic reaction. Ingestion: Prolonged or repeated ingestion will have similiar effects as acute ingestion. It may also affect the brain. (Ethyl alcohol 200 Proof) Section 12: Ecological Information Ecotoxicity: Not available. BOD5 and COD: Not available. Products of Biodegradation: Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

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Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic. Special Remarks on the Products of Biodegradation: Not available. Section 13: Disposal Considerations Waste Disposal: Waste must be disposed of in accordance with federal, state and local environmental control regulations. Section 14: Transport Information p. 6 DOT Classification: CLASS 3: Flammable liquid. Identification: : Ethanol (Ethyl alcohol 200 Proof) UNNA: 1170 PG: II Special Provisions for Transport: Not available. Section 15: Other Regulatory Information Federal and State Regulations: California prop. 65: This product contains the following ingredients for which the State of California has found to cause cancer, birth defects or other reproductive harm, which would require a warning under the statute: Ethyl alcohol 200 Proof (in alcoholic beverage) California prop. 65: This product contains the following ingredients for which the State of California has found to cause birth defects which would require a warning under the statute: Ethyl alcohol 200 Proof (in alcoholic beverage) Connecticut hazardous material survey.: Ethyl alcohol 200 Proof Illinois toxic substances disclosure to employee act: Ethyl alcohol 200 Proof Rhode Island RTK hazardous substances: Ethyl alcohol 200 Proof Pennsylvania RTK: Ethyl alcohol 200 Proof Florida: Ethyl alcohol 200 Proof Minnesota: Ethyl alcohol 200 Proof Massachusetts RTK: Ethyl alcohol 200 Proof Massachusetts spill list: Ethyl alcohol 200 Proof New Jersey: Ethyl alcohol 200 Proof TSCA 8(b) inventory: Water; Ethyl alcohol 200 Proof Other Regulations: OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). Other Classifications: WHMIS (Canada):

CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F). CLASS D-2B: Material causing other toxic effects (TOXIC). DSCL (EEC): R11- Highly flammable. S7- Keep container tightly closed. S16- Keep away from sources of ignition - No smoking. HMIS (U.S.A.): Health Hazard: 2 Fire Hazard: 3 Reactivity: 0 Personal Protection: h National Fire Protection Association (U.S.A.): Health: 2 Flammability: 3 Reactivity: 0 Specific hazard: Protective Equipment:

Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respirator when ventilation is inadequate. Splash goggles. Section 16: Other Information References: Not available. Other Special Considerations: Not available. Created: 10/09/2005 05:28 PM Last Updated: 05/21/2013 12:00 PM

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Material Safety Data Sheet Hydrochloric acid MSDS Section 1: Chemical Product and Company Identification Product Name: Hydrochloric acid Catalog Codes: SLH1462, SLH3154 CAS#: Mixture. RTECS: MW4025000 TSCA: TSCA 8(b) inventory: Hydrochloric acid CI#: Not applicable. Synonym: Hydrochloric Acid; Muriatic Acid Chemical Name: Not applicable. Chemical Formula: Not applicable. Contact Information: Sciencelab.com, Inc. 14025 Smith Rd. Houston, Texas 77396 US Sales: 1-800-901-7247 International Sales: 1-281-441-4400 Order Online: ScienceLab.com CHEMTREC (24HR Emergency Telephone), call:

1-800-424-9300 International CHEMTREC, call: 1-703-527-3887 For non-emergency assistance, call: 1-281-441-4400 Section 2: Composition and Information on Ingredients Composition: Name CAS # % by Weight Hydrogen chloride 7647-01-0 20-38 Water 7732-18-5 62-80 Toxicological Data on Ingredients: Hydrogen chloride: GAS (LC50): Acute: 4701 ppm 0.5 hours [Rat]. Section 3: Hazards Identification Potential Acute Health Effects: Very hazardous in case of skin contact (corrosive, irritant, permeator), of eye contact (irritant, corrosive), of ingestion, . Slightly hazardous in case of inhalation (lung sensitizer). Non-corrosive for lungs. Liquid or spray mist may produce tissue damage particularly on mucous membranes of eyes, mouth and respiratory tract. Skin contact may produce burns. Inhalation of the spray mist may produce severe irritation of respiratory tract, characterized by coughing, choking, or shortness of breath. Severe over-exposure can result in death. Inflammation of the eye is characterized by redness, watering, and itching. Skin inflammation is characterized by itching, scaling, reddening, or, occasionally, blistering. Potential Chronic Health Effects:

Slightly hazardous in case of skin contact (sensitizer). CARCINOGENIC EFFECTS: Classified 3 (Not classifiable for human.) by IARC [Hydrochloric acid]. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. The substance may be toxic to kidneys, liver, mucous membranes, upper respiratory tract, skin, eyes, Circulatory System, teeth. Repeated or prolonged exposure to the substance can produce target organs damage. Repeated or prolonged contact with spray mist may produce chronic eye irritation and severe skin irritation. Repeated or prolonged exposure to spray mist may produce respiratory tract irritation leading to frequent attacks of bronchial infection. Repeated exposure to a highly toxic material may produce general deterioration of health by an accumulation in one or many human organs. Section 4: First Aid Measures Eye Contact: Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Cold water may be used. Get medical attention immediately. Skin Contact:

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In case of contact, immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Cover the irritated skin with an emollient. Cold water may be used.Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention immediately. Serious Skin Contact:

Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medical attention. Inhalation:

If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention immediately. Serious Inhalation: Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. WARNING: It may be hazardous to the person providing aid to give mouth-to-mouth resuscitation when the inhaled material is toxic, infectious or corrosive. Seek immediate medical attention. Ingestion:

If swallowed, do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention immediately. Serious Ingestion: Not available. Section 5: Fire and Explosion Data Flammability of the Product: Non-flammable. Auto-Ignition Temperature: Not applicable. Flash Points: Not applicable. Flammable Limits: Not applicable. Products of Combustion: Not available. Fire Hazards in Presence of Various Substances: of metals Explosion Hazards in Presence of Various Substances: Non-explosive in presence of open flames and sparks, of shocks. Fire Fighting Media and Instructions: Not applicable. Special Remarks on Fire Hazards:

Non combustible. Calcium carbide reacts with hydrogen chloride gas with incandescence. Uranium phosphide reacts with hydrochloric acid to release spontaneously flammable phosphine. Rubidium acetylene carbides burns with slightly warm hydrochloric acid. Lithium silicide in contact with hydrogen chloride becomes incandescent. When dilute hydrochloric acid is used, gas spontaneously flammable in air is evolved. Magnesium boride treated with concentrated hydrochloric acid produces spontaneously flammble gas. Cesium acetylene carbide burns hydrogen chloride gas. Cesium carbide ignites in contact with hydrochloric acid unless acid is dilute. Reacts with most metals to produce flammable Hydrodgen gas. Special Remarks on Explosion Hazards: p. 3 Hydrogen chloride in contact with the following can cause an explosion, ignition on contact, or other violent/vigorous reaction: Acetic anhydride AgClO + CCl4 Alcohols + hydrogen cyanide, Aluminum Aluminum-titanium alloys (with HCl vapor), 2-Amino ethanol, Ammonium hydroxide, Calcium carbide Ca3P2 Chlorine + dinitroanilines (evolves gas), Chlorosulfonic acid Cesium carbide Cesium acetylene carbide, 1,1-Difluoroethylene Ethylene diamine Ethylene imine, Fluorine, HClO4 Hexalithium disilicide H2SO4 Metal acetylides or carbides, Magnesium boride, Mercuric sulfate, Oleum, Potassium permanganate, beta-Propiolactone Propylene oxide Rubidium carbide, Rubidium, acetylene carbide Sodium (with aqueous HCl), Sodium hydroxide Sodium tetraselenium, Sulfonic acid, Tetraselenium tetranitride, U3P4 , Vinyl acetate. Silver perchlorate with carbon tetrachloride in the presence of hydrochloric acid produces trichloromethyl perchlorate which detonates at 40 deg. C. Section 6: Accidental Release Measures Small Spill: Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal container. If necessary: Neutralize the residue with a dilute solution of sodium carbonate. Large Spill: Corrosive liquid. Poisonous liquid. Stop leak if without risk. Absorb with DRY earth, sand or other non-combustible material.

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Do not get water inside container. Do not touch spilled material. Use water spray curtain to divert vapor drift. Use water spray to reduce vapors. Prevent entry into sewers, basements or confined areas; dike if needed. Call for assistance on disposal. Neutralize the residue with a dilute solution of sodium carbonate. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDS and with local authorities. Section 7: Handling and Storage Precautions: Keep locked up.. Keep container dry. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Never add water to this product. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents, organic materials, metals, alkalis, moisture. May corrode metallic surfaces. Store in a metallic or coated fiberboard drum using a strong polyethylene inner package. Storage: Keep container tightly closed. Keep container in a cool, well-ventilated area. Section 8: Exposure Controls/Personal Protection Engineering Controls: Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respective threshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location. Personal Protection: Face shield. Full suit. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves. Boots. Personal Protection in Case of a Large Spill: Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product. Exposure Limits: CEIL: 5 (ppm) from OSHA (PEL) [United States] CEIL: 7 (mg/m3) from OSHA (PEL) [United States] CEIL: 5 from NIOSH CEIL: 7 (mg/m3) from NIOSH TWA: 1 STEL: 5 (ppm) [United Kingdom (UK)] TWA: 2 STEL: 8 (mg/m3) [United Kingdom (UK)]Consult local authorities for acceptable exposure limits. Section 9: Physical and Chemical Properties Physical state and appearance: Liquid. p. 4 Odor: Pungent. Irritating (Strong.) Taste: Not available. Molecular Weight: Not applicable. Color: Colorless to light yellow. pH (1% soln/water): Acidic. Boiling Point: 108.58 C @ 760 mm Hg (for 20.22% HCl in water) 83 C @ 760 mm Hg (for 31% HCl in water) 50.5 C (for 37% HCl in water) Melting Point:

-62.25°C (-80°F) (20.69% HCl in water) -46.2 C (31.24% HCl in water) -25.4 C (39.17% HCl in water) Critical Temperature: Not available. Specific Gravity: 1.1- 1.19 (Water = 1) 1.10 (20%and 22% HCl solutions) 1.12 (24% HCl solution) 1.15 (29.57% HCl solution) 1.16 (32% HCl solution) 1.19 (37% and 38%HCl solutions) Vapor Pressure: 16 kPa (@ 20°C) average Vapor Density: 1.267 (Air = 1) Volatility: Not available. Odor Threshold: 0.25 to 10 ppm Water/Oil Dist. Coeff.: Not available. Ionicity (in Water): Not available. Dispersion Properties: See solubility in water, diethyl ether. Solubility: Soluble in cold water, hot water, diethyl ether.

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Section 10: Stability and Reactivity Data Stability: The product is stable. Instability Temperature: Not available. Conditions of Instability: Incompatible materials, water Incompatibility with various substances: Highly reactive with metals. Reactive with oxidizing agents, organic materials, alkalis, water. Corrosivity: Extremely corrosive in presence of aluminum, of copper, of stainless steel(304), of stainless steel(316). Non-corrosive in presence of glass. Special Remarks on Reactivity: Reacts with water especially when water is added to the product. Absorption of gaseous hydrogen chloride on mercuric sulfate becomes violent @ 125 deg. C. Sodium reacts very violently with gaseous hydrogen chloride. Calcium phosphide and hydrochloric acid undergo very energetic reaction. It reacts with oxidizers releasing chlorine gas. Incompatible with, alkali metals, carbides, borides, metal oxides, vinyl acetate, acetylides, sulphides, phosphides, cyanides, carbonates. Reacts with most metals to produce flammable Hydrogen gas. Reacts violently (moderate reaction with heat of evolution) with water especially when water is added to the product. Isolate hydrogen chloride from heat, direct sunlight, alkalies (reacts vigorously), organic materials, and oxidizers (especially nitric acid and chlorates), amines, metals, copper and alloys (e.g. brass), hydroxides, zinc (galvanized materials), lithium silicide (incandescence), sulfuric acid(increase in temperature and pressure) Hydrogen chloride gas is emitted when this product is in contact with sulfuric acid. Adsorption of Hydrochloric Acid onto silicon dioxide results in exothmeric reaction. Hydrogen chloride causes aldehydes and epoxides to violently polymerize. Hydrogen chloride or Hydrochloric Acid in contact with the folloiwng can cause explosion or ignition on contact Special Remarks on Corrosivity: p. 5 Highly corrosive. Incompatible with copper and copper alloys. It attacks nearly all metals (mercury, gold, platinium, tantalum, silver, and certain alloys are exceptions). It is one of the most corrosive of the nonoxidizing acids in contact with copper alloys. No corrosivity data on zinc, steel. Severe Corrosive effect on brass and bronze Polymerization: Will not occur. Section 11: Toxicological Information Routes of Entry: Absorbed through skin. Dermal contact. Eye contact. Inhalation. Toxicity to Animals: Acute oral toxicity (LD50): 900 mg/kg [Rabbit]. Acute toxicity of the vapor (LC50): 1108 ppm, 1 hours [Mouse]. Acute toxicity of the vapor (LC50): 3124 ppm, 1 hours [Rat]. Chronic Effects on Humans: CARCINOGENIC EFFECTS: Classified 3 (Not classifiable for human.) by IARC [Hydrochloric acid]. May cause damage to the following organs: kidneys, liver, mucous membranes, upper respiratory tract, skin, eyes, Circulatory System, teeth. Other Toxic Effects on Humans: Very hazardous in case of skin contact (corrosive, irritant, permeator), of ingestion, . Hazardous in case of eye contact (corrosive), of inhalation (lung corrosive). Special Remarks on Toxicity to Animals: Lowest Published Lethal Doses (LDL/LCL) LDL [Man] -Route: Oral; 2857 ug/kg LCL [Human] - Route: Inhalation; Dose: 1300 ppm/30M LCL [Rabbit] - Route: Inhalation; Dose: 4413 ppm/30M Special Remarks on Chronic Effects on Humans: May cause adverse reproductive effects (fetoxicity). May affect genetic material. Special Remarks on other Toxic Effects on Humans: Acute Potential Health Effects: Skin: Corrosive. Causes severe skin irritation and burns. Eyes: Corrosive. Causes severe eye irritation/conjuntivitis, burns, corneal necrosis. Inhalation: May be fatal if inhaled. Material is extremely destructive to

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tissue of the mucous membranes and upper respiratory tract. Inhalation of hydrochloric acid fumes produces nose, throat, and larryngeal burning, and irritation, pain and inflammation, coughing, sneezing, choking sensation, hoarseness, laryngeal spasms, upper respiratory tract edema, chest pains, as well has headache, and palpitations. Inhalation of high concentrations can result in corrosive burns, necrosis of bronchial epithelium, constriction of the larynx and bronchi, nasospetal perforation, glottal closure, occur, particularly if exposure is prolonged. May affect the liver. Ingestion: May be fatal if swallowed. Causes irritation and burning, ulceration, or perforation of the gastrointestinal tract and resultant peritonitis, gastric hemorrhage and infection. Can also cause nausea, vomitting (with "coffee ground" emesis), diarrhea, thirst, difficulty swallowing, salivation, chills, fever, uneasiness, shock, strictures and stenosis (esophogeal, gastric, pyloric). May affect behavior (excitement), the cardiovascular system (weak rapid pulse, tachycardia), respiration (shallow respiration), and urinary system (kidneys- renal failure, nephritis). Acute exposure via inhalation or ingestion can also cause erosion of tooth enamel. Chronic Potential Health Effects: dyspnea, bronchitis. Chemical pneumonitis and pulmonary edema can also Section 12: Ecological Information Ecotoxicity: Not available. BOD5 and COD: Not available. Products of Biodegradation:

Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise. Toxicity of the Products of Biodegradation: The products of degradation are less toxic than the product itself. Special Remarks on the Products of Biodegradation: Not available. Section 13: Disposal Considerations Waste Disposal: p. 6 Waste must be disposed of in accordance with federal, state and local environmental control regulations. Section 14: Transport Information DOT Classification: Class 8: Corrosive material Identification: : Hydrochloric acid, solution UNNA: 1789 PG: II Special Provisions for Transport: Not available. Section 15: Other Regulatory Information Federal and State Regulations: Connecticut hazardous material survey.: Hydrochloric acid Illinois toxic substances disclosure to employee act: Hydrochloric acid Illinois chemical safety act: Hydrochloric acid New York release reporting list: Hydrochloric acid Rhode Island RTK hazardous substances: Hydrochloric acid Pennsylvania RTK: Hydrochloric acid Minnesota: Hydrochloric acid Massachusetts RTK: Hydrochloric acid Massachusetts spill list: Hydrochloric acid New Jersey: Hydrochloric acid New Jersey spill list: Hydrochloric acid Louisiana RTK reporting list: Hydrochloric acid Louisiana spill reporting: Hydrochloric acid California Director's List of Hazardous Substances: Hydrochloric acid TSCA 8(b) inventory: Hydrochloric acid TSCA 4(a) proposed test rules: Hydrochloric acid SARA 302/304/311/312 extremely hazardous substances: Hydrochloric acid SARA 313 toxic chemical notification and release reporting: Hydrochloric acid CERCLA: Hazardous substances.: Hydrochloric acid: 5000 lbs. (2268 kg) Other Regulations:

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OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances. Other Classifications: WHMIS (Canada):

CLASS D-2A: Material causing other toxic effects (VERY TOXIC). CLASS E: Corrosive liquid. DSCL (EEC): R34- Causes burns. R37- Irritating to respiratory system. S26- In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S45- In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). HMIS (U.S.A.): Health Hazard: 3 Fire Hazard: 0 Reactivity: 1 Personal Protection: National Fire Protection Association (U.S.A.): Health: 3 Flammability: 0 Reactivity: 1 Specific hazard: Protective Equipment: Gloves. Full suit. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respirator when ventilation is inadequate. Face shield. Section 16: Other Information p. 7 References: -Hawley, G.G.. The Condensed Chemical Dictionary, 11e ed., New York N.Y., Van Nostrand Reinold, 1987. -SAX, N.I. Dangerous Properties of Indutrial Materials. Toronto, Van Nostrand Reinold, 6e ed. 1984. -The Sigma-Aldrich Library of Chemical Safety Data, Edition II. -Guide de la loi et du règlement sur le transport des marchandises dangeureuses au canada. Centre de conformité internatinal Ltée. 1986. Other Special Considerations: Not available. Created: 10/09/2005 05:45 PM Last Updated: 05/21/2013 12:00 PM The information above is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.com has been advised of the possibility of such damages.

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Material Safety Data Sheet Hexanes MSDS Section 1: Chemical Product and Company Identification Product Name: Hexanes Catalog Codes: SLH2335, SLH2032 CAS#: 110-54-3 RTECS: MN9275000 TSCA: TSCA 8(b) inventory: Hexane CI#: Not applicable. Synonym: Chemical Name: Hexane Chemical Formula: C6-H14 Contact Information: Sciencelab.com, Inc. 14025 Smith Rd. Houston, Texas 77396 US Sales: 1-800-901-7247 International Sales: 1-281-441-4400 Order Online: ScienceLab.com CHEMTREC (24HR Emergency Telephone), call:

1-800-424-9300 International CHEMTREC, call: 1-703-527-3887 For non-emergency assistance, call: 1-281-441-4400 Section 2: Composition and Information on Ingredients Composition: Name CAS # % by Weight Hexanes 110-54-3 98.5-99.9 Toxicological Data on Ingredients: Hexane: ORAL (LD50): Acute: 25000 mg/kg [Rat]. Section 3: Hazards Identification Potential Acute Health Effects: Hazardous in case of skin contact (permeator), of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant), of eye contact (irritant). Potential Chronic Health Effects: CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Mutagenic for bacteria and/or yeast. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. The substance may be toxic to peripheral nervous system, skin, central nervous system (CNS). Repeated or prolonged exposure to the substance can produce target organs damage. Section 4: First Aid Measures Eye Contact: p. 2 Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelids open. Get medical attention if irritation occurs. Skin Contact: Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops. Serious Skin Contact:

Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek medical attention. Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention if symptoms appear. Serious Inhalation:

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Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek medical attention. Ingestion: Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if symptoms appear. Serious Ingestion: Not available. Section 5: Fire and Explosion Data Flammability of the Product: Flammable. Auto-Ignition Temperature: 225°C (437°F) Flash Points: CLOSED CUP: -22.5°C (-8.5°F). (TAG) Flammable Limits: LOWER: 1.15% UPPER: 7.5% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances:

Highly flammable in presence of open flames and sparks, of heat. Non-flammable in presence of shocks. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product in presence of static discharge: Not available. Fire Fighting Media and Instructions:

Flammable liquid, insoluble in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray or fog. Special Remarks on Fire Hazards: Extremely flammable liquid and vapor. Vapor may cause flash fire. Special Remarks on Explosion Hazards: Not available. Section 6: Accidental Release Measures Small Spill: Absorb with an inert material and put the spilled material in an appropriate waste disposal. Large Spill: Flammable liquid, insoluble in water. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk. Absorb with DRY earth, sand or other non-combustible material. Do not get water inside container. Do not touch spilled material. Prevent entry into sewers, basements or confined areas; dike if needed. Call for assistance on disposal. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDS and with local authorities. Section 7: Handling and Storage p. 3 Precautions:

Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Avoid contact with skin. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Keep away from incompatibles such as oxidizing agents. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame). Section 8: Exposure Controls/Personal Protection Engineering Controls:

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Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respective threshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location. Personal Protection:

Safety glasses. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves (impervious). Personal Protection in Case of a Large Spill:

Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product. Exposure Limits: TWA: 500 (ppm) from OSHA (PEL) [United States] Inhalation TWA: 1800 (mg/m3) from OSHA (PEL) [United States] Inhalation TWA: 176 (mg/m3) from ACGIH (TLV) [United States] SKIN TWA: 50 (ppm) from ACGIH (TLV) [United States] SKIN TWA: 500 STEL: 1000 (ppm) from ACGIH (TLV) [United States] Inhalation TWA: 1760 STEL: 3500 (mg/m3) from ACGIH (TLV) [United States] Inhalation Consult local authorities for acceptable exposure limits. Section 9: Physical and Chemical Properties Physical state and appearance: Liquid. Odor: Gasoline-like or petroleum-like (Slight.) Taste: Not available. Molecular Weight: 86.18g/mole Color: Clear Colorless. pH (1% soln/water): Not applicable. Boiling Point: 68°C (154.4°F) Melting Point: -95°C (-139°F) Critical Temperature: Not available. Specific Gravity: 0.66 (Water = 1) Vapor Pressure: 17.3 kPa (@ 20°C) Vapor Density: 2.97 (Air = 1) Volatility: Not available. Odor Threshold: 130 ppm Water/Oil Dist. Coeff.: The product is more soluble in oil; log(oil/water) = 3.9 Ionicity (in Water): Not available. p. 4 Dispersion Properties: See solubility in water, diethyl ether, acetone. Solubility: Soluble in diethyl ether, acetone. Insoluble in cold water, hot water. Section 10: Stability and Reactivity Data Stability: The product is stable. Instability Temperature: Not available. Conditions of Instability: Heat, ingnition sources, incompatibles. Incompatibility with various substances: Reactive with oxidizing agents. Corrosivity: Not available. Special Remarks on Reactivity: Hexane can react vigorously with strong oxidizers (e.g. chlorine, bromine, fluorine) Special Remarks on Corrosivity: Not available. Polymerization: Will not occur. Section 11: Toxicological Information Routes of Entry: Absorbed through skin. Dermal contact. Inhalation. Ingestion. Toxicity to Animals:

WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oral toxicity (LD50): 25000 mg/kg [Rat]. Acute toxicity of the gas (LC50): 48000 ppm 4 hours [Rat]. Chronic Effects on Humans:

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MUTAGENIC EFFECTS: Mutagenic for bacteria and/or yeast. May cause damage to the following organs: peripheral nervous system, skin, central nervous system (CNS). Other Toxic Effects on Humans: Very hazardous in case of ingestion, of inhalation. Hazardous in case of skin contact (permeator). Slightly hazardous in case of skin contact (irritant). Special Remarks on Toxicity to Animals: Not available. Special Remarks on Chronic Effects on Humans: May cause adverse reproductive effects based on animal data. May be tumorigenic based on animal data. May affect genetic material. Passes through the placental barrier in animal. Special Remarks on other Toxic Effects on Humans: Acute Potential Health Effects: Skin: May cause mild skin irritation. It can be absorbed through the skin in harmful amounts. Eyes: May cause mild eye irritation. Inhalation: May be harmful if inhaled. Inhalation of vapors may cause respiratory tract irritation. Overexposure may affect, brain, spinal cord, behavior/central and peripheral nervous systems (lightheadness, dizziness, hallucinations, paralysis, blurred vision, memory loss, headache, euphoria, general anesthetic, muscle weakness, numbness of the extremeties, asphyxia, unconciousness and possible death), metabolism, respiration, blood, cardiovascular system, gastrointestinal system (nausea) Ingestion: May be harmful if swallowed. May cause gastrointestinal tract irritation with abdominal pain and nausea. May also affect the liver, blood, brain, peripheral and central nervous systems. Symptoms of over exposure by ingestion are similar to that of overexposure by inhalation. Section 12: Ecological Information Ecotoxicity: Not available. BOD5 and COD: Not available. p. 5 Products of Biodegradation: Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise. Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic. Special Remarks on the Products of Biodegradation: Not available. Section 13: Disposal Considerations Waste Disposal: Waste must be disposed of in accordance with federal, state and local environmental control regulations. Section 14: Transport Information DOT Classification: CLASS 3: Flammable liquid. Identification: : Hexane UNNA: 1208 PG: II Special Provisions for Transport: Not available. Section 15: Other Regulatory Information Federal and State Regulations:

Connecticut hazardous material survey.: Hexanes Illinois toxic substances disclosure to employee act: Hexanes Illinois chemical safety act: Hexanes New York release reporting list: Hexanes Rhode Island RTK hazardous substances: Hexanes Pennsylvania RTK: Hexanes Florida: Hexanes Minnesota: Hexanes Massachusetts RTK: Hexanes Massachusetts spill list: Hexanes New Jersey: Hexanes New Jersey spill list: Hexanes Louisiana spill reporting: Hexanes TSCA 8(b) inventory: Hexanes SARA 313 toxic chemical notification and release reporting: Hexanes CERCLA: Hazardous substances.: Hexanes: 5000 lbs. (2268 kg)

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Other Regulations: OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances. Other Classifications: WHMIS (Canada): CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F). CLASS D-2B: Material causing other toxic effects (TOXIC). DSCL (EEC):

R11- Highly flammable. R20- Harmful by inhalation. R38- Irritating to skin. R51/53- Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. R62- Possible risk of impaired fertility. R65- Harmful: may cause lung damage if swallowed. R67- Vapors may cause drowsiness or dizziness. S9- Keep container in a well-ventilated place. S16- Keep away from sources of ignition - No smoking. S29- Do not empty into drains. S33- Take precautionary measures against static discharges. S36/37- Wear suitable protective clothing and gloves. S61- Avoid release to the environment. Refer to special instructions/Safety data sheets. S62- If swallowed, do not induce vomiting: seek medical advice immediately and show this HMIS (U.S.A.): Health Hazard: 2 Fire Hazard: 3 Reactivity: 0 Personal Protection: g National Fire Protection Association (U.S.A.): p. 6 Health: 1 Flammability: 3 Reactivity: 0 Specific hazard: Protective Equipment: Gloves (impervious). Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respirator when ventilation is inadequate. Safety glasses. Section 16: Other Information References: Not available. Other Special Considerations: Not available. Created: 10/10/2005 08:19 PM Last Updated: 05/21/2013 12:00 PM The information above is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.com has been advised of the possibility of such damages.

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Material Safety Data Sheet o-Xylene MSDS Section 1: Chemical Product and Company Identification Product Name: o-Xylene Catalog Codes: SLX1012 CAS#: 95-47-6 RTECS: ZE2450000 TSCA: TSCA 8(b) inventory: o-Xylene CI#: Not applicable. Synonym: 1,2-Dimethylbenzene Chemical Name: o-Xylene Chemical Formula: C6H4(CH3)2 Contact Information: Sciencelab.com, Inc. 14025 Smith Rd. Houston, Texas 77396 US Sales: 1-800-901-7247 International Sales: 1-281-441-4400 Order Online: ScienceLab.com CHEMTREC (24HR Emergency Telephone), call:

1-800-424-9300 International CHEMTREC, call: 1-703-527-3887 For non-emergency assistance, call: 1-281-441-4400 Section 2: Composition and Information on Ingredients Composition: Name CAS # % by Weight {o-}Xylene 95-47-6 100 Toxicological Data on Ingredients: o-Xylene LD50: Not available. LC50: Not available. Section 3: Hazards Identification Potential Acute Health Effects: Hazardous in case of skin contact (irritant, permeator), of eye contact (irritant), of ingestion, of inhalation. Potential Chronic Health Effects: CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH, 3 (Not classifiable for human.) by IARC. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Classified POSSIBLE for human. DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/male [POSSIBLE]. The substance may be toxic to kidneys, liver, upper respiratory tract, skin, eyes, central nervous system (CNS). Repeated or prolonged exposure to the substance can produce target organs damage. Section 4: First Aid Measures Eye Contact: p. 2 Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelids open. Get medical attention. Skin Contact: In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminated clothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention. Serious Skin Contact: Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medical attention. Inhalation:

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If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention. Serious Inhalation: Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. WARNING: It may be hazardous to the person providing aid to give mouth-to-mouth resuscitation when the inhaled material is toxic, infectious or corrosive. Seek medical attention. Ingestion: Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed, call a physician immediately. Loosen tight clothing such as a collar, tie, belt or waistband. Serious Ingestion: Not available. Section 5: Fire and Explosion Data Flammability of the Product: Flammable. Auto-Ignition Temperature: 463°C (865.4°F) Flash Points: CLOSED CUP: 17°C (62.6°F). Flammable Limits: LOWER: 0.9% UPPER: 6.7% Products of Combustion: These products are carbon oxides (CO, CO2). Fire Hazards in Presence of Various Substances: Highly flammable in presence of open flames and sparks, of heat. Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Slightly explosive in presence of open flames and sparks, of heat. Fire Fighting Media and Instructions: Flammable liquid, insoluble in water. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray or fog. Special Remarks on Fire Hazards: Vapors are heavier than air and may travel considerable distance to source of ignition and flash back. When heated to decomposition it emits acrid smoke and irritating fumes. Special Remarks on Explosion Hazards: Explosive in the form of vapor when exposed to heat or flame. Vapors may form explosive mixtures with air. Containers may explode when heated. Runoff to sewer may create fire or explosion hazard Section 6: Accidental Release Measures Small Spill: Absorb with an inert material and put the spilled material in an appropriate waste disposal. Large Spill: p. 3 Toxic flammable liquid, insoluble or very slightly soluble in water. Keep away from heat. Keep away from sources of ignition. Stop leak if without risk. Absorb with DRY earth, sand or other non-combustible material. Do not get water inside container. Do not touch spilled material. Prevent entry into sewers, basements or confined areas; dike if needed. Call for assistance on disposal. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDS and with local authorities. Section 7: Handling and Storage Precautions:

Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do

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not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents, acids. Storage: Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame). Section 8: Exposure Controls/Personal Protection Engineering Controls: Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respective threshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location. Personal Protection: Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves. Personal Protection in Case of a Large Spill: Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product. Exposure Limits:

TWA: 434 STEL: 651 (mg/m3) from ACGIH (TLV) [United States] TWA: 100 STEL: 150 (ppm) from ACGIH (TLV) [United States] STEL: 150 (ppm) from NIOSH STEL: 655 (mg/m3) from NIOSHConsult local authorities for acceptable exposure limits. Section 9: Physical and Chemical Properties Physical state and appearance: Liquid. (Mobile, nonpolar liquid.) Odor: Aromatic. Sweetish. Taste: Not available. Molecular Weight: 106.17 g/mole Color: Colorless. pH (1% soln/water): Not applicable. Boiling Point: 144.4°C (291.9°F) Melting Point: -25°C (-13°F) Critical Temperature: 359°C (678.2°F) Specific Gravity: 0.88 (Water = 1) Vapor Pressure: 0.9 kPa (@ 20°C) Vapor Density: 3.7 (Air = 1) p. 4 Volatility: Not available. Odor Threshold: 0.05 ppm Water/Oil Dist. Coeff.: The product is more soluble in oil; log(oil/water) = 3.1 Ionicity (in Water): Not available. Dispersion Properties: Dispersed in diethyl ether. Is not dispersed in cold water, hot water. See solubility in diethyl ether, acetone. Solubility: Soluble in diethyl ether, acetone. Insoluble in cold water, hot water. Section 10: Stability and Reactivity Data Stability: The product is stable. Instability Temperature: Not available. Conditions of Instability: Heat, ignition sources, flames, incompatible materials. Incompatibility with various substances: Reactive with oxidizing agents, acids. Corrosivity: Non-corrosive in presence of glass. Special Remarks on Reactivity:

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Photochemically reactive. Incompatible with strong oxidizers(e.g. chlorine, bromine, fluorine), and strong acids (e.g. nitric acid, acetic acid). Special Remarks on Corrosivity: Not available. Polymerization: Will not occur. Section 11: Toxicological Information Routes of Entry: Absorbed through skin. Dermal contact. Eye contact. Inhalation. Toxicity to Animals:

Lowest Published Lethal Dose - Inhalation (LCL): 6125 ppm 12 hours [Rat]; 6125 ppm 12 hours [Human] Lowest Published Lethal Dose - Oral: 5000 mg/kg [Rat] Chronic Effects on Humans: CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH, 3 (Not classifiable for human.) by IARC. TERATOGENIC EFFECTS: Classified POSSIBLE for human. DEVELOPMENTAL TOXICITY: Classified Reproductive system/ toxin/male [POSSIBLE]. May cause damage to the following organs: kidneys, liver, upper respiratory tract, skin, eyes, central nervous system (CNS). Other Toxic Effects on Humans: Hazardous in case of skin contact (irritant, permeator), of ingestion, of inhalation. Special Remarks on Toxicity to Animals: Not available. Special Remarks on Chronic Effects on Humans: May cause adverse reproductive effects (male) and birth defects based on animal data. 0347 Animal: embryotoxic, foetotoxic, passes through the placental barrier. 0900 Detected in maternal milk in human. Narcotic effect; may cause nervous system disturbances. Special Remarks on other Toxic Effects on Humans: Acute Potential Health Efffects Skin: May cause skin irritation. May be absorbed through skin i harmful amounts. Eyes: Causes severe eye irritation. Inhalation: Causes respiratory tract and mucous membranes irritation. May affect sense organs, behavior (Central Nervous system) which may result in dizziness, general weakness, central nervous system depression, confusion, ataxia, disorientation, lethargy, drowsiness, headaches. May also affect respiration, cardiovascular system, liver, blood, and digestive system (nausea, vomiting) Ingestion: Harmful if swallowed. Causes digestive tract irritation with nausea, vomiting p. 5 and diarrhea. May also affect metabolism, liver, and urinary system, and central nervous system (excitement followed by headache, dizziness, drowsiness and nausea). Chronic Potential Health Effects: Skin: Prolonged or repeated contact may cause defatting of skin and dermatitis. Eyes: Prolonged or repeated exposure may cause conjunctivitis or permanent eye damage. Inhalation: Chronic inhalation may cause effects similar to those of acute inhalation. Section 12: Ecological Information Ecotoxicity: Not available. BOD5 and COD: Not available. Products of Biodegradation: Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise. Toxicity of the Products of Biodegradation: The products of degradation are less toxic than the product itself. Special Remarks on the Products of Biodegradation: Not available. Section 13: Disposal Considerations Waste Disposal: Waste must be disposed of in accordance with federal, state and local environmental control regulations.

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Section 14: Transport Information DOT Classification: CLASS 3: Flammable liquid. Identification: : Xylene UNNA: 1307 PG: III Special Provisions for Transport: Not available. Section 15: Other Regulatory Information Federal and State Regulations:

Connecticut hazardous material survey.: o-Xylene Illinois chemical safety act: o-Xylene New York release reporting list: o- Xylene Pennsylvania RTK: o-Xylene Florida: o-Xylene Massachusetts RTK: o-Xylene Massachusetts spill list: o-Xylene New Jersey: o-Xylene New Jersey spill list: o-Xylene Louisiana spill reporting: o-Xylene California Director's List of Hazardous Substances: o-Xylene TSCA 8(b) inventory: o-Xylene TSCA 8(d) H and S data reporting: o-Xylene: Effective: 10/4/82; Sunset: 10/4/92 SARA 313 toxic chemical notification and release reporting: o-Xylene CERCLA: Hazardous substances.: o-Xylene: 1000 lbs. (453.6 kg) Other Regulations:

OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances. Other Classifications: WHMIS (Canada):

CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F). CLASS D-2A: Material causing other toxic effects (VERY TOXIC). DSCL (EEC): HMIS (U.S.A.): Health Hazard: 2 Fire Hazard: 3 p. 6 Reactivity: 0 Personal Protection: h National Fire Protection Association (U.S.A.): Health: 2 Flammability: 3 Reactivity: 0 Specific hazard: Protective Equipment: Gloves. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respirator when ventilation is inadequate. Splash goggles. Section 16: Other Information References: -Hawley, G.G.. The Condensed Chemical Dictionary, 11e ed., New York N.Y., Van Nostrand Reinold, 1987. -Material safety data sheet emitted by: la Commission de la SantÃ© et de la SÃ©curitÃ© du Travail du QuÃ©bec. -The Sigma-Aldrich Library of Chemical Safety Data, Edition II. -Guide de la loi et du rÃ¨glement sur le transport des marchandises dangeureuses au canada. Centre de conformitÃ© internatinal LtÃ©e. 1986. Other Special Considerations: Not available. Created: 10/11/2005 12:54 PM Last Updated: 05/21/2013 12:00 PM

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Material Safety Data Sheet Sulfuric acid MSDS Section 1: Chemical Product and Company Identification Product Name: Sulfuric acid Catalog Codes: SLS2539, SLS1741, SLS3166, SLS2371, SLS3793 CAS#: 7664-93-9 RTECS: WS5600000 TSCA: TSCA 8(b) inventory: Sulfuric acid CI#: Not applicable. Synonym: Oil of Vitriol; Sulfuric Acid Chemical Name: Hydrogen sulfate Chemical Formula: H2-SO4 Contact Information: Sciencelab.com, Inc.

14025 Smith Rd. Houston, Texas 77396 US Sales: 1-800-901-7247 International Sales: 1-281-441-4400 Order Online: ScienceLab.com CHEMTREC (24HR Emergency Telephone), call: 1-800-424-9300 International CHEMTREC, call: 1-703-527-3887 For non-emergency assistance, call: 1-281-441-4400 Section 2: Composition and Information on Ingredients Composition: Name CAS # % by Weight

Sulfuric acid 7664-93-9 95 - 98 Toxicological Data on Ingredients: Sulfuric acid: ORAL (LD50): Acute: 2140 mg/kg [Rat.]. VAPOR (LC50): Acute: 510 mg/m 2 hours [Rat]. 320 mg/m 2 hours [Mouse]. Section 3: Hazards Identification Potential Acute Health Effects: Very hazardous in case of skin contact (corrosive, irritant, permeator), of eye contact (irritant, corrosive), of ingestion, of inhalation. Liquid or spray mist may produce tissue damage particularly on mucous membranes of eyes, mouth and respiratory tract. Skin contact may produce burns. Inhalation of the spray mist may produce severe irritation of respiratory tract, characterized by coughing, choking, or shortness of breath. Severe over-exposure can result in death. Inflammation of the eye is characterized by redness, watering, and itching. Skin inflammation is characterized by itching, scaling, reddening, or, occasionally, blistering. Potential Chronic Health Effects:

CARCINOGENIC EFFECTS: Classified 1 (Proven for human.) by IARC, + (Proven.) by OSHA. Classified A2 (Suspected for human.) by ACGIH. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. The substance may be toxic to kidneys, lungs, heart, cardiovascular system, upper respiratory tract, eyes, teeth. Repeated or prolonged exposure to the substance can produce target organs damage. Repeated or prolonged p. 2 contact with spray mist may produce chronic eye irritation and severe skin irritation. Repeated or prolonged exposure to spray mist may produce respiratory tract irritation leading to frequent attacks of bronchial infection. Repeated exposure to a highly

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toxic material may produce general deterioration of health by an accumulation in one or many human organs. Section 4: First Aid Measures Eye Contact: Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Cold water may be used. Get medical attention immediately. Skin Contact:

In case of contact, immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Cover the irritated skin with an emollient. Cold water may be used.Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention immediately. Serious Skin Contact: Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medical attention. Inhalation:

If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention immediately. Serious Inhalation: Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. WARNING: It may be hazardous to the person providing aid to give mouth-to-mouth resuscitation when the inhaled material is toxic, infectious or corrosive. Seek immediate medical attention. Ingestion:

Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if symptoms appear. Serious Ingestion: Not available. Section 5: Fire and Explosion Data Flammability of the Product: Non-flammable. Auto-Ignition Temperature: Not applicable. Flash Points: Not applicable. Flammable Limits: Not applicable. Products of Combustion: Products of combustion are not available since material is non-flammable. However, products of decompostion include fumes of oxides of sulfur. Will react with water or steam to produce toxic and corrosive fumes. Reacts with carbonates to generate carbon dioxide gas. Reacts with cyanides and sulfides to form poisonous hydrogen cyanide and hydrogen sulfide respectively. Fire Hazards in Presence of Various Substances: Combustible materials Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product in presence of static discharge: Not available. Slightly explosive in presence of oxidizing materials. Fire Fighting Media and Instructions: Not applicable. Special Remarks on Fire Hazards: Metal acetylides (Monocesium and Monorubidium), and carbides ignite with concentrated sulfuric acid. White Phosphorous + boiling Sulfuric acid or its vapor ignites on contact. May ignite other combustible materials. May cause fire when sulfuric acid is mixed with Cyclopentadiene, cyclopentanone oxime, nitroaryl amines, hexalithium disilicide, phorphorous (III) oxide, and

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oxidizing agents such as chlorates, halogens, permanganates. p. 3 Special Remarks on Explosion Hazards: M i x t u r e s o f s u l f u r i c a c i d a n d a n y o f t h e f o l l o w i n g c a n e x p l o d e : p - n i t r o t o l u e n e , p e n t a s i l v e r trihydroxydiaminophosphate, perchlorates, alcohols with strong hydrogen peroxide, ammonium tetraperoxychromate, mercuric nitrite, potassium chlorate, potassium permanganate with potassium chloride, carbides, nitro compounds, nitrates, carbides, phosphorous, iodides, picratres, fulminats, dienes, alcohols (when heated) Nitramide decomposes explosively on contact with concentrated sulfuric acid. 1,3,5-Trinitrosohexahydro-1,3,5-triazine + sulfuric acid causes explosive decompositon. Section 6: Accidental Release Measures Small Spill: Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal container. If necessary: Neutralize the residue with a dilute solution of sodium carbonate. Large Spill:

Corrosive liquid. Poisonous liquid. Stop leak if without risk. Absorb with DRY earth, sand or other non-combustible material. Do not get water inside container. Do not touch spilled material. Use water spray curtain to divert vapor drift. Use water spray to reduce vapors. Prevent entry into sewers, basements or confined areas; dike if needed. Call for assistance on disposal. Neutralize the residue with a dilute solution of sodium carbonate. Be careful that the product is not present at a concentration level above TLV. Check TLV on the MSDS and with local authorities. Section 7: Handling and Storage Precautions: Keep locked up.. Keep container dry. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Never add water to this product. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents, reducing agents, combustible materials, organic materials, metals, acids, alkalis, moisture. May corrode metallic surfaces. Store in a metallic or coated fiberboard drum using a strong polyethylene inner package. Storage: Hygroscopic. Reacts. violently with water. Keep container tightly closed. Keep container in a cool, well-ventilated area. Do not store above 23°C (73.4°F). Section 8: Exposure Controls/Personal Protection Engineering Controls: Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respective threshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location. Personal Protection: Face shield. Full suit. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves. Boots. Personal Protection in Case of a Large Spill: Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product. Exposure Limits:

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TWA: 1 STEL: 3 (mg/m3) [Australia] Inhalation TWA: 1 (mg/m3) from OSHA (PEL) [United States] Inhalation TWA: 1 STEL: 3 (mg/m3) from ACGIH (TLV) [United States] [1999] Inhalation TWA: 1 (mg/m3) from NIOSH [United States] Inhalation TWA: 1 (mg/m3) [United Kingdom (UK)]Consult local authorities for acceptable exposure limits. Section 9: Physical and Chemical Properties p. 4 Physical state and appearance: Liquid. (Thick oily liquid.) Odor: Odorless, but has a choking odor when hot. Taste: Marked acid taste. (Strong.) Molecular Weight: 98.08 g/mole Color: Colorless. pH (1% soln/water): Acidic. Boiling Point: 270°C (518°F) - 340 deg. C Decomposes at 340 deg. C Melting Point: -35°C (-31°F) to 10.36 deg. C (93% to 100% purity) Critical Temperature: Not available. Specific Gravity: 1.84 (Water = 1) Vapor Pressure: Not available. Vapor Density: 3.4 (Air = 1) Volatility: Not available. Odor Threshold: Not available. Water/Oil Dist. Coeff.: Not available. Ionicity (in Water): Not available. Dispersion Properties: See solubility in water. Solubility: Easily soluble in cold water. Sulfuric is soluble in water with liberation of much heat. Soluble in ethyl alcohol. Section 10: Stability and Reactivity Data Stability: The product is stable. Instability Temperature: Not available. Conditions of Instability: Conditions to Avoid: Incompatible materials, excess heat, combustible material materials, organic materials, exposure to moist air or water, oxidizers, amines, bases. Always add the acid to water, never the reverse. Incompatibility with various substances: Reactive with oxidizing agents, reducing agents, combustible materials, organic materials, metals, acids, alkalis, moisture. Corrosivity: Extremely corrosive in presence of aluminum, of copper, of stainless steel(316). Highly corrosive in presence of stainless steel(304). Non-corrosive in presence of glass. Special Remarks on Reactivity: Hygroscopic. Strong oxidizer. Reacts violently with water and alcohol especially when water is added to the product. Incompatible (can react explosively or dangerously) with the following: ACETIC ACID, ACRYLIC ACID, AMMONIUM HYDROXIDE, CRESOL, CUMENE, DICHLOROETHYL ETHER, ETHYLENE CYANOHYDRIN, ETHYLENEIMINE, NITRIC ACID, 2-NITROPROPANE, PROPYLENE OXIDE, SULFOLANE, VINYLIDENE CHLORIDE, DIETHYLENE GLYCOL MONOMETHYL ETHER, ETHYL ACETATE, ETHYLENE CYANOHYDRIN, ETHYLENE GLYCOL MONOETHYL ETHER ACETATE, GLYOXAL, METHYL ETHYL KETONE, dehydrating agents, organic materials, moisture (water), Acetic anhydride, Acetone, cyanohydrin, Acetone+nitric acid, Acetone + potassium dichromate, Acetonitrile, Acrolein, Acrylonitrile, Acrylonitrile +water, Alcohols + hydrogen peroxide, ally compounds such as Allyl alcohol, and Allyl Chloride, 2-Aminoethanol, Ammonium

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hydroxide, Ammonium triperchromate, Aniline, Bromate + metals, Bromine pentafluoride, n-Butyraldehyde, Carbides, Cesium acetylene carbide, Chlorates, Cyclopentanone oxime, chlorinates, Chlorates + metals, Chlorine trifluoride, Chlorosulfonic acid, 2-cyano-4-nitrobenzenediazonium hydrogen sulfate, Cuprous nitride, p-chloronitrobenzene, 1,5-Dinitronaphthlene + p. 5 sulfur, Diisobutylene, p-dimethylaminobenzaldehyde, 1,3-Diazidobenzene, Dimethylbenzylcarbinol + hydrogen peroxide, Epichlorohydrin, Ethyl alcohol + hydrogen peroxide, Ethylene diamine, Ethylene glycol and other glycols, , Ethylenimine, Fulminates, hydrogen peroxide, Hydrochloric acid, Hydrofluoric acid, Iodine heptafluoride, Indane + nitric acid, Iron, Isoprene, Lithium silicide, Mercuric nitride, Mesityl oxide, Mercury nitride, Metals (powdered), Nitromethane, Nitric acid + glycerides, p-Nitrotoluene, Pentasilver trihydroxydiaminophosphate, Perchlorates, Perchloric acid, Permanganates + benzene, 1- Phenyl-2-methylpropyl alcohol + hydrogen peroxide, Phosphorus, Phosphorus isocyanate, Picrates, Potassium tert-butoxide, Potassium chlorate, Potassium Permanganate and other permanganates, halogens, amines, Potassium Permanganate + Potassium chloride, Potassium Permanganate + water, Propiolactone (beta)-, Pyridine, Rubidium aceteylene carbide, Silver permanganate, Sodium, Sodium carbonate, sodium hydroxide, Steel, styrene monomer, toluene + nitric acid, Vinyl acetate, Thalium (I) azidodithiocarbonate, Zinc chlorate, Zinc Iodide, azides, carbonates, cyanides, sulfides, sulfites, alkali hydrides, carboxylic acid anhydrides, nitriles, olefinic organics, aqueous acids, cyclopentadiene, cyano-alcohols, metal acetylides, Hydrogen gas is generated by the action of the acid on most metals (i.e. lead, copper, tin, zinc, aluminum, etc.). Concentrated sulfuric acid oxidizes, dehydrates, or sulfonates most organic compounds. Special Remarks on Corrosivity: Non-corrosive to lead and mild steel, but dillute acid attacks most metals. Attacks many metals releasing hydrogen. Minor corrosive effect on bronze. No corrosion data on brass or zinc. Polymerization: Will not occur. Section 11: Toxicological Information Routes of Entry: Absorbed through skin. Dermal contact. Eye contact. Inhalation. Ingestion. Toxicity to Animals:

WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE. Acute oral toxicity (LD50): 2140 mg/kg [Rat.]. Acute toxicity of the vapor (LC50): 320 mg/m3 2 hours [Mouse]. Chronic Effects on Humans: CARCINOGENIC EFFECTS: Classified 1 (Proven for human.) by IARC, + (Proven.) by OSHA. Classified A2 (Suspected for human.) by ACGIH. May cause damage to the following organs: kidneys, lungs, heart, cardiovascular system, upper respiratory tract, eyes, teeth. Other Toxic Effects on Humans: Extremely hazardous in case of inhalation (lung corrosive). Very hazardous in case of skin contact (corrosive, irritant, permeator), of eye contact (corrosive), of ingestion, . Special Remarks on Toxicity to Animals: Not available. Special Remarks on Chronic Effects on Humans: Mutagenicity: Cytogenetic Analysis: Hamster, ovary = 4mmol/L Reproductive effects: May cause adverse reproductive effects based on animal data. Developmental abnormalities (musculoskeletal) in rabbits at a dose of 20 mg/m3 for 7 hrs.(RTECS)

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Teratogenecity: neither embryotoxic, fetoxic, nor teratogenetic in mice or rabbits at inhaled doses producing some maternal toxicity Special Remarks on other Toxic Effects on Humans: Acute Potential Health Effects: Skin: Causes severe skin irritation and burns. Continued contact can cause tissue necrosis. Eye: Causes severe eye irritation and burns. May cause irreversible eye injury. Ingestion: Harmful if swallowed. May cause permanent damage to the digestive tract. Causes gastrointestial tract burns. May cause perforation of the stomach, GI bleeding, edema of the glottis, necrosis and scarring, and sudden circulatory collapse(similar to acute inhalation). It may also cause systemic toxicity with acidosis. Inhalation: May cause severe irritation of the respiratory tract and mucous membranes with sore throat, coughing, shortness of breath, and delayed lung edema. Causes chemical burns to the repiratory tract. Inhalation may be fatal as a result of spasm, inflammation, edema of the larynx and bronchi, chemical pneumonitis, and pulmonary edema. Cause corrosive action on mucous membranes. May affect cardiovascular system (hypotension, depressed cardiac output, bradycardia). Circulatory collapse with clammy skin, weak and rapid pulse, shallow respiration, and scanty urine may follow. Circulatory shock is often the immediate cause of death. May also affect teeth(changes in teeth and supporting structures - erosion, discoloration). Chronic Potential Health Effects: Inhalation: Prolonged or repeated inhalation may affect behavior (muscle contraction or spasticity), urinary system (kidney damage), and cardiovascular system, heart (ischemic heart leisons), and respiratory system/lungs(pulmonary edema, lung damage), teeth (dental discoloration, erosion). Skin: Prolonged or repeated skin contact may cause dermatitis, an allergic skin reaction. p. 6 Section 12: Ecological Information Ecotoxicity: Ecotoxicity in water (LC50): 49 mg/l 48 hours [bluegill/sunfish]. BOD5 and COD: Not available. Products of Biodegradation: Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise. Toxicity of the Products of Biodegradation: The products of degradation are less toxic than the product itself. Special Remarks on the Products of Biodegradation: Not available. Section 13: Disposal Considerations Waste Disposal: Sulfuric acid may be placed in sealed container or absorbed in vermiculite, dry sand, earth, or a similar material. It may also be diluted and neutralized. Be sure to consult with local or regional authorities (waste regulators) prior to any disposal. Waste must be disposed of in accordance with federal, state and local environmental control regulations. Section 14: Transport Information DOT Classification: Class 8: Corrosive material Identification: : Sulfuric acid UNNA: 1830 PG: II Special Provisions for Transport: Not available. Section 15: Other Regulatory Information Federal and State Regulations: Illinois toxic substances disclosure to employee act: Sulfuric acid New York release reporting list: Sulfuric acid Rhode Island RTK hazardous substances: Sulfuric acid Pennsylvania RTK: Sulfuric acid Minnesota: Sulfuric acid Massachusetts

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RTK: Sulfuric acid New Jersey: Sulfuric acid California Director's List of Hazardous Substances (8 CCR 339): Sulfuric acid Tennessee RTK: Sulfuric acid TSCA 8(b) inventory: Sulfuric acid SARA 302/304/311/312 extremely hazardous substances: Sulfuric acid SARA 313 toxic chemical notification and release reporting: Sulfuric acid CERCLA: Hazardous substances.: Sulfuric acid: 1000 lbs. (453.6 kg) Other Regulations:

OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances. Other Classifications: WHMIS (Canada): CLASS D-1A: Material causing immediate and serious toxic effects (VERY TOXIC). CLASS E: Corrosive liquid. DSCL (EEC): R35- Causes severe burns. S2- Keep out of the reach of children. S26- In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S30- Never add water to this product. S45- In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). HMIS (U.S.A.): Health Hazard: 3 Fire Hazard: 0 Reactivity: 2 p. 7 Personal Protection: National Fire Protection Association (U.S.A.): Health: 3 Flammability: 0 Reactivity: 2 Specific hazard: Protective Equipment: Gloves. Full suit. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respirator when ventilation is inadequate. Face shield. Section 16: Other Information References: -Material safety data sheet emitted by: la Commission de la Santé et de la Sécurité du Travail du Québec. -The Sigma-Aldrich Library of Chemical Safety Data, Edition II. -Hawley, G.G.. The Condensed Chemical Dictionary, 11e ed., New York N.Y., Van Nostrand Reinold, 1987. Other Special Considerations: Not available. Created: 10/09/2005 11:58 PM Last Updated: 05/21/2013 12:00 PM The information above is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.com has been advised of the possibility of such damages.

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Aldrich - 157147 Page 1 of 7

SIGMA-ALDRICH sigma-aldrich.com

SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Version 5.0 Revision Date 25.10.2012 Print Date 16.01.2015 GENERIC EU MSDS - NO COUNTRY SPECIFIC DATA - NO OEL DATA 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1 Product identifiers

Product name : Valeroyl chloride Product Number : 157147 Brand : Aldrich CAS-No. : 638-29-9 1.2 Relevant identified uses of the substance or mixture and uses advised against Identified uses : Laboratory chemicals, Manufacture of substances 1.3 Details of the supplier of the safety data sheet Company : Sigma-Aldrich Chemicals Pvt Limited Plot No 12 Bommasandra - Jigani Link Road 560100 BANGALORE INDIA Telephone : +91 80-6621 9400 Fax : +91 80-6621 9450 1.4 Emergency telephone number Emergency Phone # : +91-9880711432 2. HAZARDS IDENTIFICATION 2.1 Classification of the substance or mixture Classification according to Regulation (EC) No 1272/2008 [EU-GHS/CLP] Flammable liquids (Category 3) Acute toxicity, Inhalation (Category 3) Skin corrosion (Category 1A) Classification according to EU Directives 67/548/EEC or 1999/45/EC Flammable. Harmful by inhalation. Causes severe burns. 2.2 Label elements Labelling according Regulation (EC) No 1272/2008 [CLP]

Pictogram Signal word Danger Hazard statement(s) H226 Flammable liquid and vapour. H314 Causes severe skin burns and eye damage. H331 Toxic if inhaled. Precautionary statement(s) P261 Avoid breathing vapours. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310 Immediately call a POISON CENTER or doctor/ physician. Aldrich - 157147 Page 2 of 7

Supplemental Hazard Statements none According to European Directive 67/548/EEC as amended. Hazard symbol(s) R-phrase(s) R10 Flammable. R20 Harmful by inhalation. R35 Causes severe burns. S-phrase(s) S26 In case of contact with eyes, rinse immediately with plenty of water and

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seek medical advice. S36/37/39 Wear suitable protective clothing, gloves and eye/face protection. S45 In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). 2.3 Other hazards

Lachrymator. 3. COMPOSITION/INFORMATION ON INGREDIENTS 3.1 Substances

Formula : C5H9ClO Molecular Weight : 120,58 g/mol 4. FIRST AID MEASURES 4.1 Description of first aid measures General advice Consult a physician. Show this safety data sheet to the doctor in attendance. If inhaled If breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician. In case of skin contact Take off contaminated clothing and shoes immediately. Wash off with soap and plenty of water. Take victim immediately to hospital. Consult a physician. In case of eye contact Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician. If swallowed Do NOT induce vomiting. Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician. 4.2 Most important symptoms and effects, both acute and delayed Material is extremely destructive to tissue of the mucous membranes and upper respiratory tract, eyes, and skin., Cough, Shortness of breath, Headache, Nausea 4.3 Indication of any immediate medical attention and special treatment needed

no data available 5. FIREFIGHTING MEASURES 5.1 Extinguishing media Suitable extinguishing media Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide. 5.2 Special hazards arising from the substance or mixture Carbon oxides, Hydrogen chloride gas 5.3 Advice for firefighters Wear self contained breathing apparatus for fire fighting if necessary. Aldrich - 157147 Page 3 of 7

5.4 Further information Use water spray to cool unopened containers. 6. ACCIDENTAL RELEASE MEASURES 6.1 Personal precautions, protective equipment and emergency procedures

Wear respiratory protection. Avoid breathing vapors, mist or gas. Ensure adequate ventilation. Remove all sources of ignition. Evacuate personnel to safe areas. Beware of vapours accumulating to form explosive concentrations. Vapours can accumulate in low areas. 6.2 Environmental precautions

Prevent further leakage or spillage if safe to do so. Do not let product enter drains. Discharge into the environment must be avoided. 6.3 Methods and materials for containment and cleaning up Contain spillage, and then collect with an electrically protected vacuum cleaner or by wet-brushing and place in container for disposal according to local regulations (see section 13). 6.4 Reference to other sections

For disposal see section 13. 7. HANDLING AND STORAGE 7.1 Precautions for safe handling

Avoid contact with skin and eyes. Avoid inhalation of vapour or mist.

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Keep away from sources of ignition - No smoking.Take measures to prevent the build up of electrostatic charge. 7.2 Conditions for safe storage, including any incompatibilities Store in cool place. Keep container tightly closed in a dry and well-ventilated place. Containers which are opened must be carefully resealed and kept upright to prevent leakage. Hydrolyses readily. 7.3 Specific end uses no data available 8. EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1 Control parameters Components with workplace control parameters 8.2 Exposure controls Appropriate engineering controls Avoid contact with skin, eyes and clothing. Wash hands before breaks and immediately after handling the product. Personal protective equipment Eye/face protection Tightly fitting safety goggles. Faceshield (8-inch minimum). Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU). Skin protection Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands. The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it. Splash protection Material: butyl-rubber Minimum layer thickness: 0,3 mm Break through time: > 30 min Aldrich - 157147 Page 4 of 7

Material tested:Butoject® (Aldrich Z677647, Size M) data source: KCL GmbH, D-36124 Eichenzell, phone +49 (0)6659 873000, e-mail [email protected], test method: EN374 If used in solution, or mixed with other substances, and under conditions which differ from EN 374, contact the supplier of the CE approved gloves. This recommendation is advisory only and must be evaluated by an Industrial Hygienist familiar with the specific situation of anticipated use by our customers. It should not be construed as offering an approval for any specific use scenario. Body Protection Complete suit protecting against chemicals, Flame retardant antistatic protective clothing, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace. Respiratory protection

Where risk assessment shows air-purifying respirators are appropriate use a full-face respirator with multi-purpose combination (US) or type ABEK (EN 14387) respirator cartridges as a backup to engineering controls. If the respirator is the sole means of protection, use a full-face supplied air respirator. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). 9. PHYSICAL AND CHEMICAL PROPERTIES 9.1 Information on basic physical and chemical properties a) Appearance Form: clear, liquid Colour: colourless b) Odour no data available c) Odour Threshold no data available d) pH no data available e) Melting point/freezing point

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no data available f) Initial boiling point and boiling range 125 - 127 °C - lit. g) Flash point 32 °C - closed cup h) Evaporation rate no data available i) Flammability (solid, gas) no data available j) Upper/lower flammability or explosive limits no data available k) Vapour pressure 56,1 hPa at 50 °C 11,5 hPa at 20 °C l) Vapour density no data available m) Relative density 1,016 g/mL at 25 °C n) Water solubility no data available o) Partition coefficient: noctanol/ water no data available p) Autoignition temperature no data available q) Decomposition temperature no data available r) Viscosity no data available s) Explosive properties no data available t) Oxidizing properties no data available Aldrich - 157147 Page 5 of 7

9.2 Other safety information no data available 10. STABILITY AND REACTIVITY 10.1 Reactivity no data available 10.2 Chemical stability no data available 10.3 Possibility of hazardous reactions no data available 10.4 Conditions to avoid

Heat, flames and sparks. 10.5 Incompatible materials Water, Alcohols, Oxidizing agents, Strong bases 10.6 Hazardous decomposition products Other decomposition products - no data available 11. TOXICOLOGICAL INFORMATION 11.1 Information on toxicological effects Acute toxicity LD50 Inhalation - rat - 4 h - 2.070 mg/m3 Skin corrosion/irritation

Skin - rabbit - Corrosive Serious eye damage/eye irritation

no data available Respiratory or skin sensitization no data available Germ cell mutagenicity no data available Carcinogenicity IARC: No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC. Reproductive toxicity

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no data available Specific target organ toxicity - single exposure no data available Specific target organ toxicity - repeated exposure no data available Aspiration hazard no data available Potential health effects Inhalation Toxic if inhaled. Material is extremely destructive to the tissue of the mucous membranes and upper respiratory tract. Ingestion May be harmful if swallowed. Causes burns. Skin May be harmful if absorbed through skin. Causes skin burns. Eyes Causes eye burns. Signs and Symptoms of Exposure Material is extremely destructive to tissue of the mucous membranes and upper respiratory tract, eyes, and skin., Cough, Shortness of breath, Headache, Nausea Aldrich - 157147 Page 6 of 7

Additional Information RTECS: Not available 12. ECOLOGICAL INFORMATION 12.1 Toxicity

Toxicity to fish LC50 - Leuciscus idus (Golden orfe) - 46 - 100 mg/l - 96 h 12.2 Persistence and degradability Biodegradability Result: - Readily biodegradable. 12.3 Bioaccumulative potential no data available 12.4 Mobility in soil no data available 12.5 Results of PBT and vPvB assessment no data available 12.6 Other adverse effects

Harmful to aquatic life. no data available Harmful to aquatic life. 13. DISPOSAL CONSIDERATIONS 13.1 Waste treatment methods Product Burn in a chemical incinerator equipped with an afterburner and scrubber but exert extra care in igniting as this material is highly flammable. Offer surplus and non-recyclable solutions to a licensed disposal company. Contaminated packaging Dispose of as unused product. 14. TRANSPORT INFORMATION 14.1 UN number

ADR/RID: 2502 IMDG: 2502 IATA: 2502 14.2 UN proper shipping name ADR/RID: VALERYL CHLORIDE IMDG: VALERYL CHLORIDE IATA: Valeryl chloride 14.3 Transport hazard class(es) ADR/RID: 8 (3) IMDG: 8 (3) IATA: 8 (3) 14.4 Packaging group ADR/RID: II IMDG: II IATA: II 14.5 Environmental hazards

ADR/RID: no IMDG Marine pollutant: no IATA: no 14.6 Special precautions for user no data available 15. REGULATORY INFORMATION

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This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006. 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture no data available 15.2 Chemical Safety Assessment

no data available Aldrich - 157147 Page 7 of 7

16. OTHER INFORMATION Further information Copyright 2012 Sigma-Aldrich Co. LLC. License granted to make unlimited paper copies for internal use only. The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. Sigma-Aldrich Corporation and its Affiliates shall not be held liable for any damage resulting from handling or from contact with the above product. See www.sigmaaldrich. com and/or the reverse side of invoice or packing slip for additional terms and conditions of sale.

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Tributyl Tin Chloride Chlorotributylstannane; Monochlorotribuitylin; Stannane, tributylchloro-; Tin, tri-n-butyl, chloride; Tri-n-butylin chloride; Tributylchlorotin; Tributylstannium chloride; Tributylstannyl chloride; Tributyltin chloride; Tributyltin-chloride Stannane, chlorotributyl- C12-H27-Cl-Sn Not available. WH6820000 1461-22-9 T2022 Not available.

SPECTRUM LABORATORY PRODUCTS INC. 14422 S. SAN PEDRO STREET GARDENA, CA 90248 CALL (310) 516-8000 SPECTRUM LABORATORY PRODUCTS INC. 14422 S. SAN PEDRO STREET GARDENA, CA 90248

1 2 0

Material Safety Data Sheet NFPA HMIS Personal Protective Equipment

Section 1. Chemical Product and Company Identification Common Name/

Trade Name

Catalog

Number(s).

CAS#

RTECS

CI#

Manufacturer

Synonym

Chemical Name

Chemical Family

IN CASE OF EMERGENCY

CHEMTREC (24hr) 800-424-9300

Chemical Formula

Supplier See Section 15. Commercial Name(s) Not available. TSCA TSCA 8(b) inventory: Tributyl Tin Chloride

2

1

0 Health Hazard Fire Hazard Reactivity

Page Number: 1 Tributyl Tin Chloride: ORAL (LD50): Acute: 129 mg/kg [Rat]. 60 mg/kg [Mouse]. 147 mg/kg [Hamster]. 1) Tributyl Tin Chloride 1461-22-9 0.1 100 Toxicological Data

on Ingredients

Name

Section 2.Composition and Information on Ingredients Exposure Limits

TWA (mg/m3) STEL (mg/m3) CEIL (mg/m3) % by Weight CAS # Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Severe over-exposure can result in death. CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH. MUTAGENIC EFFECTS: Mutagenic for bacteria and/or yeast. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available.

A- 103

Repeated exposure to a highly toxic material may produce general deterioration of health by an accumulation in one or many human organs.

Section 3. Hazards Identification Potential Acute Health

Effects

Potential Chronic Health

Effects

Continued on Next Page Tributyl Tin Chloride Page Number: 2

If swallowed, do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention immediately. Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Get medical attention. In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminated clothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention. Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medical attention. If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention. Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek medical attention. Not available.

Section 4. First Aid Measures Eye Contact

Skin Contact

Serious Skin Contact

Inhalation

Serious Inhalation

Ingestion

Serious Ingestion >150°C (302°F) May be combustible at high temperature. These products are carbon oxides (CO, CO2), halogenated compounds. CLOSED CUP: >112°C (233.6°F). Not available. SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray, fog or foam. Do not use water jet. Slightly flammable to flammable in presence of open flames and sparks, of heat. When heated to decomposition it emits toxic fumes of hydrogen chloride, carbon monoxide, carbon dioxide, tin/tin oxides. Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product in presence of static discharge: Not available. Not available.

Section 5. Fire and Explosion Data Flammability of the Product

Auto-Ignition Temperature

Flash Points

Flammable Limits

Products of Combustion

Fire Hazards in Presence of

Various Substances

Explosion Hazards in

Presence of Various

Substances

Fire Fighting Media

and Instructions

Special Remarks on

Fire Hazards

Special Remarks on

Explosion Hazards Absorb with an inert material and put the spilled material in an appropriate waste disposal. Poisonous liquid. Stop leak if without risk. Do not get water inside container. Do not touch spilled material. Use water spray to reduce vapors. Prevent entry into sewers, basements or confined areas; dike if needed. Eliminate all ignition sources. Call for assistance on disposal. Be careful that the product is not present at a concentration level above TLV. Check TLV

A- 104

on the MSDS and with local authorities.

Section 6. Accidental Release Measures Small Spill

Large Spill


Keep container tightly closed. Keep container in a cool, well-ventilated area. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents.

Section 7. Handling and Storage Precautions

Storage Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respective threshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location. Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Gloves. Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product. TWA: 0.1 STEL: 0.2 (mg(Sn)/m3) from ACGIH (TLV) [United States] TWA: 0.1 (mg(Sn)/m3) from OSHA (PEL) [United States] TWA: 0.1 (mg(Sn)/m3) from NIOSH [United States] TWA: 0.1 STEL: 0.2 (mg(Sn)/m3) [United Kingdom (UK)] Consult local authorities for acceptable exposure limits.

Section 8. Exposure Controls/Personal Protection Engineering Controls

Personal Protection

Personal Protection in Case

of a Large Spill

Exposure Limits 171°C (339.8°F) 173 C. @ 25 mm Hg. Liquid. Not available. Not applicable. -9°C (15.8°F) 1.2 (Water = 1) 11.2 (Air = 1) Not available. The product is more soluble in oil; log(oil/water) = 4.8 Not available. Not available. Insoluble in cold water. Soluble in common organic solvents, including alcohol, heptane, benzene, toluene. Insoluble in cold water, but hydrolyzes in hot water. Not available. Not available. 325.49 g/mole Stench. Not available. Clear Colorless.

Section 9. Physical and Chemical Properties Physical state and

appearance

Odor

Taste

Color

Molecular Weight

pH (1% soln/water)

Boiling Point

Melting Point

Critical Temperature

Specific Gravity

Vapor Pressure

Vapor Density

Volatility

Odor Threshold

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Water/Oil Dist. Coeff.

Ionicity (in Water)

Dispersion Properties

Solubility


The product is stable. Not available. Reactive with oxidizing agents. Not available. Not available. Not available. Excess heat, incompatible materials.

Section 10. Stability and Reactivity Data Stability

Instability Temperature

Conditions of Instability

Incompatibility with various

substances

Corrosivity

Special Remarks on

Reactivity

Special Remarks on

Corrosivity

Polymerization Will not occur. Absorbed through skin. Eye contact. Inhalation. Acute oral toxicity (LD50): 60 mg/kg [Mouse]. Hazardous in case of skin contact (irritant), of ingestion, of inhalation. CARCINOGENIC EFFECTS: A4 (Not classifiable for human or animal.) by ACGIH. MUTAGENIC EFFECTS: Mutagenic for bacteria and/or yeast. Lethal Dose/Conc 50% Kill: LD50[Rabbit] - Route: Oral; Dose: 30 ug/kg Acute Potential Health Effects: Skin: Causes skin irritation. Eyes: Causes moderate to severe eye irritation. Inhalation: Inhalation of mist or vapor may cause respiratory tract irritation. Ingestion: Harmful if swallowed. May cause anorexia, nausea, vomiting, diarrhea). May affect behavior/central nervous system/peripheral nervous system (ataxia, tremor, local anesthetic). Chronic Potential Health Effects: Ingestion: Prolonged or repeated ingestion may cause weight loss. It may also affect the spleen, thymus, respiration (respiratory depression). Skin: Prolonged or repeated skin contact may cause dermatitis. May cause adverse reproductive effects and birth defects (teratogenic) May affect genetic material (mutagenic)

Section 11. Toxicological Information Routes of Entry

Toxicity to Animals

Chronic Effects on Humans

Other Toxic Effects on

Humans

Special Remarks on

Toxicity to Animals

Special Remarks on

Chronic Effects on Humans

Special Remarks on other

Toxic Effects on Humans Not available. Not available. Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise. The products of degradation are as toxic as the product itself. Tributyl tin compounds are extremely toxic to marine life.

Section 12. Ecological Information Ecotoxicity

BOD5 and COD

Products of Biodegradation

Toxicity of the Products

of Biodegradation

Special Remarks on the

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Products of Biodegradation


Section 13. Disposal Considerations Waste Disposal Waste must be disposed of in accordance with federal, state and local environmental control regulations. DOT Classification CLASS 6.1: Poisonous material. Not available. UNNA: 2788: Organotin compound, liquid, n.o.s. (Chlorotributyltin) PG: III

Section 14. Transport Information Identification

DOT (Pictograms)

Special Provisions for

Transport OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances (EINECS No. 215-958-7). Canada: Listed on Canadian Domestic Substance List (DSL). China: Listed on National Inventory. Japan: Listed on National Inventory (ENCS). Korea: Listed on National Inventory (KECI). Philippines: Listed on National Inventory (PICCS). CLASS D-1B: Material causing immediate and serious toxic effects (TOXIC). CLASS D-2B: Material causing other toxic effects (TOXIC). R25- Toxic if swallowed. R36/38- Irritating to eyes and skin. R50/53- Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

Section 15. Other Regulatory Information and Pictograms Other Regulations

Other Classifications WHMIS (Canada)

DSCL (EEC)

HMIS (U.S.A.) Health Hazard Fire Hazard Reactivity

National Fire Protection

Association (U.S.A.) Personal Protection

Health

Flammability

Reactivity

Specific hazard

Federal and State

Regulations TSCA 8(b) inventory: Tributyl Tin Chloride California

Proposition 65

Warnings California prop. 65: This product contains the following ingredients for which the State of California has found to cause cancer which would require a warning under the statute: No products were found. California prop. 65: This product contains the following ingredients for which the State of California has found to cause birth defects which would require a warning under the statute: No products were found. S26- In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36/37/39- Wear suitable protective clothing, gloves and eye/face protection. S45- In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). S60- This material and its container must be disposed of as hazardous waste. S61- Avoid release to the environment. Refer to special instructions/Safety data sheets.

Continued on Next Page

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Tributyl Tin Chloride Page Number: 6 6

WHMIS (Canada)

(Pictograms)

DSCL (Europe)

(Pictograms)

TDG (Canada)

(Pictograms)

ADR (Europe)

(Pictograms)

Protective Equipment Vapor respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respirator when ventilation is inadequate. Lab coat. Splash goggles. Gloves. Major Uses: Intermediate; rodenticide, rodent-repellent cable coating; industrial biocide; in agricultural chemicals, wood preservatives, and marine antifoulants. Use of tributyltin compounds in antifoulants is restricted because of toxicity to aquatic organisms and the EPA is cooperating in international efforts for global phase-out. Not available. CALL (310) 516-8000

Notice to Reader

Verified by Sonia Owen.

Printed 12/2/2008.

Validated by Sonia Owen on 11/13/2008.

Other Special

Considerations

References

Section 16. Other Information MSDS Code T0210

Continued on Next Page Tributyl Tin Chloride Page Number: 7 All chemicals may pose unknown hazards and should be used with caution. This Material Safety Data Sheet (MSDS) applies only to the material

as packaged. If this product is combined with other materials,

deteriorates, or becomes contaminated, it may pose hazards not mentioned in this MSDS. It shall be the user's responsibility to develop proper

methods of handling and personal protection based on the actual

conditions of use. While this MSDS is based on technical data judged to be reliable, Spectrum Quality Products, Inc. assumes no responsibility for

the completeness or accuracy of the information contained herein.

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Thionyl chloride

• Sulfurous oxychloride

• Sulfinyl chloride

• Sulfur chloride oxide

• Sulfurous dichloride

• Thionyl dichloride

Formula SOCl2 (Cl2OS)

Structure

Description Colorless to yellow to reddish liquid with a pungent odor of sulfur dioxide.

Uses For making acyl chlorides, to replace hydroxide of sulfhydryl groups with

chlorine atoms.


CAS 7719-09-7

EC



EC Class Reacts violently with water; Harmful; Contact with water liberates

toxic gas; Corrosive

EC Risk Phrase R 14-20/22-29-35

EC Safety Phrase S 26-36/37/39-45

ENCS (MITI) 1-818

RTECS XM5150000

RTECS class Z Other (Z)

UN (DOT) 1836

Merck 12,9485




Properties.

Formula mass 118.97


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Boiling point, °C 76

Vapor pressure, mmHg 96.65 torr (20 °C)


Density 1.64 g/cm3 (20 °C)

Solubility in water Reacts

Viscosity 0.801 C



Storage

Keep container closed when not in use. Store in a cool, dry, well-

ventilated area away from incompatible substances. Keep away from

water. Corrosives area. Keep away from acids. Do not store in metal

containers.

Handling

Keep container tightly closed. Do not get on skin or in eyes. Do not

ingest or inhale. Use with adequate ventilation. Do not allow contact

with water. Discard contaminated shoes.

Protection

Eyes: Wear appropriate protective eyeglasses or chemical safety

goggles as described by OSHA's eye and face protection regulations in

29 CFR 1910.133 or European Standard EN166. Skin: Wear nitrile-

latex gloves, apron, and/or clothing. Wear appropriate protective

gloves to prevent skin exposure. Clothing: Wear nitrile-latex gloves,

apron, and/or clothing. Wear appropriate protective clothing to

minimize contact with skin.

Respirators

A respiratory protection program that meets OSHA's 29 CFR 1910.134

and ANSI Z88.2 requirements or European Standard EN 149 must be

followed whenever workplace conditions warrant a respirator's use.

Small spills/leaks

Avoid runoff into storm sewers and ditches which lead to waterways.

Clean up spills immediately, using the appropriate protective

equipment. Use water spray to disperse the gas/vapor. Use a spark-

proof tool. Do not get water inside containers. Cover with dry earth,

dry sand, or other non-combustible material followed with plastic sheet

to minimize spreading and contact with water.

Disposal code 24

Stability Stable under normal temperatures and pressures.

Incompatibilities Water, metals, ammonia, dimethyl sulfoxide, dimethyl formamide,

lithium, sodium, alkalies.

Decomposition Hydrogen chloride, chlorine, oxides of sulfur, irritating and toxic fumes

and gases.

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Fire.

Flash Point,°C 140

Fire fighting

Wear a self-contained breathing apparatus in pressure-demand,

MSHA/NIOSH (approved or equivalent), and full protective gear.

Water Reactive. Material will react with water and may release a

flammable and/or toxic gas. Containers may explode in the heat of a

fire. Vapors may be heavier than air. They can spread along the

ground and collect in low or confined areas. Contact with metals

may evolve flammable hydrogen gas. Extinguishing media: Do

NOT use water directly on fire. If water is the only media available,

use in flooding amounts. Do NOT get water inside containers. Cool

containers with flooding quantities of water until well after fire is

out. For small fires, use dry chemical or carbon dioxide.

Fire potential May burn but does not ignite readily.

Hazards

May ignite combustibles (wood, paper, oil, clothing, etc.).

Substance will react with water (some violently), releasing corrosive

and/or toxic gases. Flammable/toxic gases may accumulate in

confined areas (basement, tanks, hopper/tank cars, etc.)Contact with

metals may evolve flammable hydrogen gas. Containers may

explode when heated or if contaminated with water. Substance may

be transported in a molten form.

Combustion products

Fire will produce irritating, corrosive and/or toxic gases. Reaction

with water may generate much heat which will increase the

concentration of fumes in the air.

NFPA Health 4

Flammability 0

Reactivity 2

Special W

Health.

Exposure limit(s) NIOSH REL: C 1 ppm (5 mg/m3)

Exposure effects

Ingestion May cause severe and permanent damage to the digestive tract.

Causes gastrointestinal tract burns.

Inhalation

Harmful if inhaled. Causes chemical burns to the respiratory

tract. Inhalation may be fatal as a result of spasm, inflammation,

edema of the larynx and bronchi, chemical pneumonitis and

pulmonary edema.

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Skin Causes skin burns. Causes redness and pain.

First aid

Ingestion

Do NOT induce vomiting. If victim is conscious and alert, give

2-4 cupfuls of milk or water. Never give anything by mouth to

an unconscious person. Get medical aid immediately.

Inhalation


immediately. If breathing is difficult, give oxygen. DO NOT use

mouth-to-mouth respiration. If breathing has ceased apply

artificial respiration using oxygen and a suitable mechanical

device such as a bag and a mask.

Skin

Get medical aid immediately. Immediately flush skin with plenty

of soap and water for at least 15 minutes while removing

contaminated clothing and shoes. Wash clothing before reuse.

Destroy contaminated shoes.

Transport.

UN number 1836

Response guide 137

Hazard class 8

Packing Group I

USCG CHRIS Code TNC

USCG

Compatatibility

Group

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Material Safety Data Sheet Thionyl chloride, 99.5+% ACC# 19477 Section 1 - Chemical Product and Company Identification MSDS Name: Thionyl chloride, 99.5+% Product Grade : SQ Catalog Numbers: 28225 Synonyms: Thionyl Chloride Company Identification:

Fisher Scientific Part of Thermo Fisher Scientific THERMO ELECTRON LLS INDIA PVT.LTD. Godrej Coliseum, 101A-101B, Somaiya Hospital Road, Off Eastern Express Highway, Sion (East), Mumbai-400 022, India For information, call: 022 – 6680 3001/2, Call India Toll Free – 1800 209 7001 Emergency Number: 022-66803004/14 For CHEMTREC assistance, call: 800-424-9300 [International] For International CHEMTREC assistance, call: 703-527-3887 [International] Section 2 - Composition, Information on Ingredients CAS# Chemical Name Percent EINECS/ELINCS 7719-09-7 Thionyl chloride >99.5 231-748-8

Section 3 - Hazards Identification EMERGENCY OVERVIEW Appearance: clear colorless to slightly yellow liquid. Danger! May be fatal if inhaled. Exposure through inhalation may result in delayed pulmonary edema, which may be fatal. Onset of acute lung injury after toxic exposure may be delayed up to 72 hours after initial exposure. Causes burns by all exposure routes. Water-reactive. Contact with water liberates toxic gas. Lachrymator (substance which increases the flow of tears). Harmful if inhaled or swallowed. Light sensitive. Target Organs: Respiratory system, eyes, skin. Potential Health Effects Eye: Causes eye burns. Causes redness and pain. Lachrymator (substance which increases the flow of tears). May cause chemical conjunctivitis and corneal damage. Skin: Causes skin burns. May be absorbed through the skin in harmful amounts. Causes redness and pain. Ingestion: Harmful if swallowed. May cause severe and permanent damage to the digestive tract. Causes gastrointestinal tract burns. Inhalation: Causes chemical burns to the respiratory tract. Inhalation may be fatal as a result of spasm, inflammation, edema of the larynx and bronchi, chemical pneumonitis and pulmonary edema. Exposure through inhalation may result in delayed pulmonary edema which may be fatal. Death may result hours after initial exposure. Toxic exposure to fumes of Thionyl Chloride reacting with water may result in a delayed pulmonary response (longer than two weeks) of bronchiolitis Obliterans-inflammation of the bronchioles. Chronic: Chronic exposure may cause effects similar to those of acute exposure.

Section 4 - First Aid Measures Eyes: Get medical aid immediately. Do NOT allow victim to rub eyes or keep eyes closed. Extensive irrigation with water is required (at least 30 minutes). Skin: Get medical aid immediately. Immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Wash clothing before reuse. Destroy contaminated shoes. Ingestion: Do not induce vomiting. If victim is conscious and alert, give 2-4 cupfuls of milk or water. Never give anything by mouth to an unconscious person. Get medical aid immediately. Inhalation: Get medical aid immediately. Remove from exposure and move to fresh air

A- 113

immediately. If breathing is difficult, give oxygen. Do NOT use mouth-to-mouth resuscitation. If breathing has ceased apply artificial respiration using oxygen and a suitable mechanical device such as a bag and a mask. Notes to Physician: Treat symptomatically and supportively.

Section 5 - Fire Fighting Measures General Information: As in any fire, wear a self-contained breathing apparatus in pressure-demand, MSHA/NIOSH (approved or equivalent), and full protective gear. Water reactive. Material will react with water and may release a flammable and/or toxic gas. Containers may explode in the heat of a fire. Vapors may be heavier than air. They can spread along the ground and collect in low or confined areas. Contact with metals may evolve flammable hydrogen gas. Extinguishing Media: Do NOT use water directly on fire. If water is the only media available, use in flooding amounts. Do NOT get water inside containers. Cool containers with flooding quantities of water until well after fire is out. For small fires, use dry chemical or carbon dioxide. Flash Point: Not applicable. Autoignition Temperature: Not available. Explosion Limits, Lower:Not available. Upper: Not available. NFPA Rating: (estimated) Health: 4; Flammability: 0; Instability: 2; Special Hazard: - W-

Section 6 - Accidental Release Measures General Information: Use proper personal protective equipment as indicated in Section 8. Spills/Leaks: Avoid runoff into storm sewers and ditches which lead to waterways. Clean up spills immediately, observing precautions in the Protective Equipment section. Use a spark-proof tool. Do not get water inside containers. Cover with dry earth, dry sand, or other non-combustible material followed with plastic sheet to minimize spreading and contact with water.

Section 7 - Handling and Storage Handling: Keep container tightly closed. Do not get on skin or in eyes. Do not ingest or inhale. Use with adequate ventilation. Store protected from light. Do not allow contact with water. Discard contaminated shoes. Storage: Keep container closed when not in use. Store in a cool, dry, well-ventilated area away from incompatible substances. Keep away from water. Corrosives area. Keep away from acids. Do not store in metal containers. Store protected from light.

Section 8 - Exposure Controls, Personal Protection Engineering Controls: Use process enclosure, local exhaust ventilation, or other engineering controls to control airborne levels below recommended exposure limits. Facilities storing or utilizing this material should be equipped with an eyewash facility and a safety shower. Use only under a chemical fume hood. Exposure Limits Chemical Name ACGIH NIOSH OSHA - Final PELs Thionyl chloride 1 ppm Ceiling none listed none listed OSHA Vacated PELs: Thionyl chloride: No OSHA Vacated PELs are listed for this chemical. Personal Protective Equipment Eyes: Wear appropriate protective eyeglasses or chemical safety goggles as described by OSHA's eye and face protection regulations in 29 CFR 1910.133 or European Standard EN166. Skin: Wear nitrile-latex gloves, apron, and/or clothing. Clothing: Wear nitrile-latex gloves, apron, and/or clothing. Respirators: A respiratory protection program that meets OSHA's 29 CFR 1910.134 and ANSI Z88.2 requirements or European Standard EN 149 must be followed whenever workplace conditions warrant respirator use.

Section 9 - Physical and Chemical Properties Physical State: Liquid Appearance: clear colorless to slightly yellow

A- 114

Odor: Suffocating odor pH: Not available. Vapor Pressure: 110 mm Hg @ 26 deg C Vapor Density: 4.1 Evaporation Rate:Not available. Viscosity: 0.801 deg C Boiling Point: 76 deg C @ 760.00mm Hg Freezing/Melting Point:-105 deg C Decomposition Temperature:140 deg C Solubility: reacts with water forming sulfur dioxide Specific Gravity/Density:1.6310g/cm3 Molecular Formula:Cl2OS Molecular Weight:118.97

Section 10 - Stability and Reactivity Chemical Stability: Reacts violently with water to form the toxic gases hydrogen chloride and sulfur dioxide. Conditions to Avoid: Light, contact with water, temperatures above 140°C. Incompatibilities with Other Materials: Water, metals, acids, bases, alcohols, amines, ammonia, dimethyl sulfoxide, dimethyl formamide, lithium, sodium, alkalies. Hazardous Decomposition Products: Hydrogen chloride, chlorine, oxides of sulfur. Hazardous Polymerization: Will not occur.

Section 11 - Toxicological Information RTECS#: CAS# 7719-09-7: XM5150000 LD50/LC50: CAS# 7719-09-7: Inhalation, rat: LC50 = 500 ppm/1H; . Carcinogenicity: CAS# 7719-09-7: Not listed by ACGIH, IARC, NTP, or CA Prop 65. Epidemiology: Healthy 23-year old male had a short-term exposure to Thionyl chloride fumes. Within 18 days he complained of dyspnea. Pulmonary function tests indicated broncholistis obliterans. Progressive respiratory failure developed (Konichezky, et al, 1993). Teratogenicity: No information found Reproductive Effects: No information found Mutagenicity: No information found Neurotoxicity: No information found Other Studies:

Section 12 - Ecological Information No information available.

Section 13 - Disposal Considerations Chemical waste generators must determine whether a discarded chemical is classified as a hazardous waste. US EPA guidelines for the classification determination are listed in 40 CFR Parts 261.3. Additionally, waste generators must consult state and local hazardous waste regulations to ensure complete and accurate classification. RCRA P-Series: None listed. RCRA U-Series: None listed.

Section 14 - Transport Information US DOT Canada TDG Shipping Name: THIONYL CHLORIDE THIONYL CHLORIDE Hazard Class: 8 8 UN Number: UN1836 UN1836 Packing Group: I I

Section 15 - Regulatory Information US FEDERAL TSCA CAS# 7719-09-7 is listed on the TSCA inventory.

A- 115

Health & Safety Reporting List None of the chemicals are on the Health & Safety Reporting List. Chemical Test Rules None of the chemicals in this product are under a Chemical Test Rule. Section 12b None of the chemicals are listed under TSCA Section 12b. TSCA Significant New Use Rule None of the chemicals in this material have a SNUR under TSCA. CERCLA Hazardous Substances and corresponding RQs None of the chemicals in this material have an RQ. SARA Section 302 Extremely Hazardous Substances None of the chemicals in this product have a TPQ. SARA Codes CAS # 7719-09-7: immediate, reactive. Section 313 No chemicals are reportable under Section 313. Clean Air Act: This material does not contain any hazardous air pollutants. This material does not contain any Class 1 Ozone depletors. This material does not contain any Class 2 Ozone depletors. Clean Water Act: None of the chemicals in this product are listed as Hazardous Substances under the CWA. None of the chemicals in this product are listed as Priority Pollutants under the CWA. None of the chemicals in this product are listed as Toxic Pollutants under the CWA. OSHA: CAS# 7719-09-7 is considered highly hazardous by OSHA. STATE CAS# 7719-09-7 can be found on the following state right to know lists: California, New Jersey, Pennsylvania, Minnesota, Massachusetts. California Prop 65 California No Significant Risk Level: None of the chemicals in this product are listed. European/International Regulations European Labeling in Accordance with EC Directives Hazard Symbols: C Risk Phrases: R 14 Reacts violently with water. R 20/22 Harmful by inhalation and if swallowed. R 29 Contact with water liberates toxic gas. R 35 Causes severe burns. Safety Phrases: S 26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S 36/37/39 Wear suitable protective clothing, gloves and eye/face pr otection. S 45 In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). WGK (Water Danger/Protection) CAS# 7719-09-7: 1 Canada - DSL/NDSL CAS# 7719-09-7 is listed on Canada's DSL List. Canada - WHMIS This product has a WHMIS classification of D1A, E, F. This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations and the MSDS contains all of the information required by those regulations. Canadian Ingredient Disclosure List CAS# 7719-09-7 is listed on the Canadian Ingredient Disclosure List.

Section 16 - Additional Information MSDS Creation Date: 4/26/1999

A- 116

MSDS Number: T3913 * * * * * Effective Date: 08/03/04 * * * * * Supercedes: 11/02/01

TOLUENE

1. Product Identification

Synonyms: Methylbenzene; Toluol; Phenylmethane

CAS No.: 108-88-3

Molecular Weight: 92.14

Chemical Formula: C6H5-CH3

Product Codes: J.T. Baker: 5375, 5812, 9336, 9351, 9364, 9456, 9457, 9459, 9460, 9462, 9466, 9472, 9476

Mallinckrodt: 4483, 8092, 8604, 8608, 8610, 8611, V560

2. Composition/Information on Ingredients

Ingredient CAS No Percent Hazardous

--------------------------------------- ------------ ------------ ---------

Toluene 108-88-3 100% Yes

3. Hazards Identification

Emergency Overview --------------------------

POISON! DANGER! HARMFUL OR FATAL IF SWALLOWED. HARMFUL IF




RESPIRATORY TRACT.

SAF-T-DATA(tm) Ratings (Provided here for your convenience)

-----------------------------------------------------------------------------------------------------------

Health Rating: 2 - Moderate (Life)

Flammability Rating: 3 - Severe (Flammable)

Reactivity Rating: 1 - Slight

Contact Rating: 3 - Severe (Life)

Lab Protective Equip: GOGGLES & SHIELD; LAB COAT & APRON; VENT HOOD;

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PROPER GLOVES; CLASS B EXTINGUISHER

Storage Color Code: Red (Flammable)

-----------------------------------------------------------------------------------------------------------

Potential Health Effects ----------------------------------

Inhalation: Inhalation may cause irritation of the upper respiratory tract. Symptoms of overexposure may

include fatigue, confusion, headache, dizziness and drowsiness. Peculiar skin sensations (e. g.

pins and needles) or numbness may be produced. Very high concentrations may cause

unconsciousness and death.

Ingestion: Swallowing may cause abdominal spasms and other symptoms that parallel over-exposure

from inhalation. Aspiration of material into the lungs can cause chemical pneumonitis, which

may be fatal.

Skin Contact: Causes irritation. May be absorbed through skin.

Eye Contact: Causes severe eye irritation with redness and pain.

Chronic Exposure: Reports of chronic poisoning describe anemia, decreased blood cell count and bone marrow

hypoplasia. Liver and kidney damage may occur. Repeated or prolonged contact has a

defatting action, causing drying, redness, dermatitis. Exposure to toluene may affect the

developing fetus.

Aggravation of Pre-existing Conditions: Persons with pre-existing skin disorders or impaired liver or kidney function may be more

susceptible to the effects of this substance. Alcoholic beverage consumption can enhance the

toxic effects of this substance.

4. First Aid Measures

Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is

difficult, give oxygen. CALL A PHYSICIAN IMMEDIATELY.

Ingestion: Aspiration hazard. If swallowed, DO NOT INDUCE VOMITING. Give large quantities of

water. Never give anything by mouth to an unconscious person. Get medical attention

immediately. If vomiting occurs, keep head below hips to prevent aspiration into lungs.

Skin Contact: In case of contact, immediately flush skin with plenty of soap and water for at least 15

minutes while removing contaminated clothing and shoes. Wash clothing before reuse. Call a

physician immediately.

Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper

eyelids occasionally. Get medical attention immediately.

5. Fire Fighting Measures

Fire: Flash point: 7C (45F) CC

Autoignition temperature: 422C (792F)

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Flammable limits in air % by volume:

lel: 3.3; uel: 19

Flammable liquid and vapor!

Dangerous fire hazard when exposed to heat or flame. Vapors can flow along surfaces to

distant ignition source and flash back.

Explosion: Above flash point, vapor-air mixtures are explosive within flammable limits noted above.

Contact with strong oxidizers may cause fire or explosion. Sensitive to static discharge.

Fire Extinguishing Media: Dry chemical, foam or carbon dioxide. Water may be used to flush spills away from

exposures and to dilute spills to non-flammable mixtures.

Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained

breathing apparatus with full facepiece operated in the pressure demand or other positive

pressure mode. Water spray may be used to keep fire exposed containers cool.

6. Accidental Release Measures

Ventilate area of leak or spill. Remove all sources of ignition. Wear appropriate personal

protective equipment as specified in Section 8. Isolate hazard area. Keep unnecessary and

unprotected personnel from entering. Contain and recover liquid when possible. Use non-

sparking tools and equipment. Collect liquid in an appropriate container or absorb with an

inert material (e. g., vermiculite, dry sand, earth), and place in a chemical waste container. Do

not use combustible materials, such as saw dust. Do not flush to sewer! If a leak or spill has

not ignited, use water spray to disperse the vapors, to protect personnel attempting to stop

leak, and to flush spills away from exposures. US Regulations (CERCLA) require reporting

spills and releases to soil, water and air in excess of reportable quantities. The toll free

number for the US Coast Guard National Response Center is (800) 424-8802.

J. T. Baker SOLUSORB® solvent adsorbent is recommended for spills of this product.

7. Handling and Storage

Protect against physical damage. Store in a cool, dry well-ventilated location, away from any

area where the fire hazard may be acute. Outside or detached storage is preferred. Separate

from incompatibles. Containers should be bonded and grounded for transfers to avoid static

sparks. Storage and use areas should be No Smoking areas. Use non-sparking type tools and

equipment, including explosion proof ventilation. Containers of this material may be

hazardous when empty since they retain product residues (vapors, liquid); observe all

warnings and precautions listed for the product.

8. Exposure Controls/Personal Protection

Airborne Exposure Limits: Toluene:

- OSHA Permissible Exposure Limit (PEL):

200 ppm (TWA); 300 ppm (acceptable ceiling conc.); 500 ppm (maximum conc.).

- ACGIH Threshold Limit Value (TLV):

50 ppm (TWA) skin, A4 - Not Classifiable as a Human Carcinogen.

Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures below

the Airborne Exposure Limits. Local exhaust ventilation is generally preferred because it can

control the emissions of the contaminant at its source, preventing dispersion of it into the

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general work area. Please refer to the ACGIH document, Industrial Ventilation, A Manual of

Recommended Practices, most recent edition, for details.

Personal Respirators (NIOSH Approved): If the exposure limit is exceeded and engineering controls are not feasible, a half-face organic

vapor respirator may be worn for up to ten times the exposure limit, or the maximum use

concentration specified by the appropriate regulatory agency or respirator supplier, whichever

is lowest. A full-face piece organic vapor respirator may be worn up to 50 times the exposure

limit, or the maximum use concentration specified by the appropriate regulatory agency or

respirator supplier, whichever is lowest. For emergencies or instances where the exposure

levels are not known, use a full-face piece positive-pressure, air-supplied respirator.

WARNING: Air-purifying respirators do not protect workers in oxygen-deficient

atmospheres.

Skin Protection: Wear impervious protective clothing, including boots, gloves, lab coat, apron or coveralls, as

appropriate, to prevent skin contact.

Eye Protection: Use chemical safety goggles and/or a full face shield where splashing is possible. Maintain

eye wash fountain and quick-drench facilities in work area.

9. Physical and Chemical Properties

Appearance: Clear, colorless liquid.

Odor: Aromatic benzene-like.

Solubility: 0.05 gm/100gm water @ 20C (68F).

Specific Gravity: 0.86 @ 20C / 4 C

pH: No information found.

% Volatiles by volume @ 21C (70F): 100

Boiling Point: 111C (232F)

Melting Point: -95C (-139F)

Vapor Density (Air=1): 3.14

Vapor Pressure (mm Hg): 22 @ 20C (68F)

Evaporation Rate (BuAc=1): 2.24

10. Stability and Reactivity

Stability: Stable under ordinary conditions of use and storage. Containers may burst when heated.

Hazardous Decomposition Products: Carbon dioxide and carbon monoxide may form when heated to decomposition.

Hazardous Polymerization: Will not occur.

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Incompatibilities: Heat, flame, strong oxidizers, nitric and sulfuric acids, chlorine, nitrogen tetraoxide; will

attack some forms of plastics, rubber, coatings.

Conditions to Avoid: Heat, flames, ignition sources and incompatibles.

11. Toxicological Information

Toxicological Data: Oral rat LD50: 636 mg/kg; skin rabbit LD50: 14100 uL/kg; inhalation rat LC50: 49

gm/m3/4H; Irritation data: skin rabbit, 500 mg, Moderate; eye rabbit, 2 mg/24H, Severe.

Investigated as a tumorigen, mutagen, reproductive effector.

Reproductive Toxicity: Has shown some evidence of reproductive effects in laboratory animals. --------\Cancer Lists\------------------------------------------------------

---NTP Carcinogen---

Ingredient Known Anticipated IARC Category

------------------------------------ ----- ----------- -------------

Toluene (108-88-3) No No 3

12. Ecological Information

Environmental Fate: When released into the soil, this material may evaporate to a moderate extent. When released

into the soil, this material is expected to leach into groundwater. When released into the soil,

this material may biodegrade to a moderate extent. When released into water, this material

may evaporate to a moderate extent. When released into water, this material may biodegrade

to a moderate extent. When released into the air, this material may be moderately degraded

by reaction with photochemically produced hydroxyl radicals. When released into the air, this

material is expected to have a half-life of less than 1 day. This material is not expected to

significantly bioaccumulate. This material has a log octanol-water partition coefficient of less

than 3.0. Bioconcentration factor = 13.2 (eels).

Environmental Toxicity: This material is expected to be toxic to aquatic life. The LC50/96-hour values for fish are

between 10 and 100 mg/l.

13. Disposal Considerations

Whatever cannot be saved for recovery or recycling should be handled as hazardous waste

and sent to a RCRA approved incinerator or disposed in a RCRA approved waste facility.

Processing, use or contamination of this product may change the waste management options.

State and local disposal regulations may differ from federal disposal regulations. Dispose of

container and unused contents in accordance with federal, state and local requirements.

14. Transport Information

Domestic (Land, D.O.T.) -----------------------


Hazard Class: 3

UN/NA: UN1294

Packing Group: II


International (Water, I.M.O.) -----------------------------

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Hazard Class: 3

UN/NA: UN1294

Packing Group: II


15. Regulatory Information


Ingredient TSCA EC Japan Australia

----------------------------------------------- ---- --- ----- ---------

Toluene (108-88-3) Yes Yes Yes Yes


--Canada--

Ingredient Korea DSL NDSL Phil.

----------------------------------------------- ----- --- ---- -----

Toluene (108-88-3) Yes Yes No Yes


-SARA 302- ------SARA 313------

Ingredient RQ TPQ List Chemical Catg.

----------------------------------------- --- ----- ---- --------------

Toluene (108-88-3) No No Yes No


-RCRA- -TSCA-

Ingredient CERCLA 261.33 8(d)

----------------------------------------- ------ ------ ------

Toluene (108-88-3) 1000 U220 No

Chemical Weapons Convention: No TSCA 12(b): No CDTA: Yes

SARA 311/312: Acute: Yes Chronic: Yes Fire: Yes Pressure: No

Reactivity: No (Pure / Liquid)

WARNING: THIS PRODUCT CONTAINS A CHEMICAL(S) KNOWN TO THE STATE OF

CALIFORNIA TO CAUSE BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM.

Australian Hazchem Code: 3[Y]E

Poison Schedule: S6

WHMIS: This MSDS has been prepared according to the hazard criteria of the Controlled Products

Regulations (CPR) and the MSDS contains all of the information required by the CPR.

16. Other Information

NFPA Ratings: Health: 2 Flammability: 3 Reactivity: 0

Label Hazard Warning: POISON! DANGER! HARMFUL OR FATAL IF SWALLOWED. HARMFUL IF




RESPIRATORY TRACT.

Label Precautions: Keep away from heat, sparks and flame.

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Keep container closed.

Use only with adequate ventilation.

Wash thoroughly after handling.

Avoid breathing vapor.

Avoid contact with eyes, skin and clothing.

Label First Aid: Aspiration hazard. If swallowed, DO NOT INDUCE VOMITING. Give large quantities of

water. Never give anything by mouth to an unconscious person. If vomiting occurs, keep

head below hips to prevent aspiration into lungs. If inhaled, remove to fresh air. If not

breathing, give artificial respiration. If breathing is difficult, give oxygen. In case of contact,

immediately flush eyes or skin with plenty of water for at least 15 minutes. Remove

contaminated clothing and shoes. Wash clothing before reuse. In all cases call a physician

immediately.

Product Use: Laboratory Reagent.

Revision Information: MSDS Section(s) changed since last revision of document include: 3.

Disclaimer: ***************************************************************************

*********************

Mallinckrodt Baker, Inc. provides the information contained herein in good faith but

makes no representation as to its comprehensiveness or accuracy. This document is

intended only as a guide to the appropriate precautionary handling of the material by a

properly trained person using this product. Individuals receiving the information must

exercise their independent judgment in determining its appropriateness for a particular

purpose. MALLINCKRODT BAKER, INC. MAKES NO REPRESENTATIONS OR

WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT

LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A

PARTICULAR PURPOSE WITH RESPECT TO THE INFORMATION SET FORTH

HEREIN OR THE PRODUCT TO WHICH THE INFORMATION REFERS.

ACCORDINGLY, MALLINCKRODT BAKER, INC. WILL NOT BE RESPONSIBLE

FOR DAMAGES RESULTING FROM USE OF OR RELIANCE UPON THIS

INFORMATION. ***************************************************************************

*********************

Prepared by: Environmental Health & Safety

Phone Number: (314) 654-1600 (U.S.A.)

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ANNEXURE – 13

COPY OF HON'BLE HIGH COURT'S STAY ORDER & EXTENSIONS

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Documents

01.Cover Page-N