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Certificate of Analysis
PARACETAMOL IPCERTIFIED REFERENCE MATERIAL
(SECONDARY REFERENCE STANDARD)
4-hydroxyacetanilide
CERTIFIED PURITY: 99.4%(Assay on as is basis)
NOMINAL PACKAGE SIZE: 2g
CATALOG #: 1000001 Lot #: PADM001
ISSUE DATE: 28 August 2015 CAS #: 103-90-2
Note: Certificates may be updated due to Pharmacopeial Lot change or the availability of new data. Check our website www.padmlab.com for the most current version.
CRM EXPIRATION: 12 Months from issue date (Proper Storage and Handling Required).
RECEIPT DATE:_______________Note: This space is provided for convenience only and its use is not required.
STORAGE: Store Protected from light and moisture.
CHEMICAL FORMULA: C8H9NO2 Molecular weight: 151.17
PHYSICAL DESCRIPTION: white powder in amber vial
THERAPEUTIC CATEGORY: Analgesic, Antipyretic. DATE OF COA: 28.08.2015
HAZARDS: Read Safety data sheet before using. All chemical reference materials should be considered potentially hazardous and should be used only by qualified laboratory personnel.
PɅDM Laboratories Pvt. Ltd.#453/A, 12th cross, 4th Phase, Peenya Industrial Area, Bangalore-560058, Karnataka, INDIA
E-mail : [email protected] www.padmlab.com
INSTRUCTIONS FOR USE: Do not dry, use as is. The internal pressure of container may be slightly different from the atmospheric pressure at the user’s location. Open slowly and carefully to avoid dispersion of the material. This material is intended for R&D use only. Not for drug, household or other uses.
TRACEABILITY ASSAY
Comparative assay demonstrates direct traceability to Pharmacopeial Standards specification: 99.0-101.0% (dried), Indian Pharmacopeia (IP).
METHOD: POTENTIOMETRIC TITRATION
Dissolve in water and 1M sulphuric acid. Titrate with 0.1M ceric ammonium sulphate, determining theend point potentiometrically.Ref.: Paracetamol; IPASSAY vs. IP REFERENCE STANDARD (as is basis)
ASSAY VALUE
99.4%
vs. IP LOT
IPRS/54/14Labeled Content= 99.5% w/w on as is basis
LOSS ON DRYING/VOLATILESMethod: Dry in an oven.
Mean of two measurements, Loss = 0.13%
IDENTIFICATION TESTS
INFRARED SPECTROPHOTOMETERY (Comparative identification analysis demonstrates directtraceability to Pharmacopeial standards)Representative IR spectrum from Lot: IPRS/54/14 Analysis.
PɅDM Laboratories Pvt. Ltd.#453/A, 12th cross, 4th Phase, Peenya Industrial Area, Bangalore-560058, Karnataka, INDIA
E-mail : [email protected] www.padmlab.com
Representative IR spectrum from Lot: PADM001 Analysis
MASS SPECTROSCOPY
Representative Mass spectrum from Lot: PADM001 Analysis
REMARKS
All the above parameters meets the requirements of IP monograph.
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HEAD-QUALITY
PɅDM Laboratories Pvt. Ltd.#453/A, 12th cross, 4th Phase, Peenya Industrial Area, Bangalore-560058, Karnataka, INDIA
E-mail : [email protected] www.padmlab.com
