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Pharma
Active Ingredients / ExcipientsTopical Ingredients
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Our principals for pharma specialities
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Content
Active Pharmaceutical Ingredients 4
Avesta Pharma 4Macrogol 4
Dow Corning® 4Simeticone and Emulsion 4Dimeticone Fluid 4
Tereos Starch & Sweeteners 5Glucose Monohydrate Injectable Grade 5
Pharmaceutical Excipients 5
Avesta Pharma 5Macrogol 5
Tereos Starch & Sweeteners 6Starch 6Dextrose/Glucose 6Maltodextrin 6Polyoles 7
Tereos Sugar France 7Sucrose 7Sucrose with functional additives 8
Lubricants 8Stearates 8
CPKelco - Cellulose Derivative 8Carmellose Sodium 8
CPKelco - Biogums 9Xanthan gum 9Pectine 9Carrageenan 9Gellan Gum 10
Yung Zip 10Sodium Starch Glycolate 10
Dow Corning® - Silicones 10Fluids 10Volatiles and Cyclics 11Waxes 11Blends 11Emulsifiers 11
Petroleum Jellies 12
Dow Corning® - Topical Ingredients 12Low volatile fluids 12Fluids 12Speciality Fluids 13Blends 13Waxes 13Emulsifier 14Resins 14
WNC – Ingredients 14Topical Ingredients 14Functional Ingredient Blends 14
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Active Pharmaceutical Ingredients
Avesta Pharma
Macrogol
Dimeticone Fluid
Dow Corning®
Simeticone and Emulsion
Product
Product
Product
Macrogol 3350
Macrogol 4000
Q7-9120 Silicone Fluid 20 cSt 100 cSt 350 cSt 1000 cSt 12500 cSt
Q7-2243 LVA, Simethicone USP
Antifoam M Compound
Q7-2587 30% Simethicone Emulsion USP
7-9255 30% Simethicone Emulsion USP
• Active for laxatives
• ICH Q7 GMP
• EDMF Macrogol 3350 available, EDMF Macrogol 4000 in preparation
• Active for prescription/OTC/medical device antiflatulents
• ICH Q7 GMP
• FDA registered production site
• Active for prescription/OTC/medical device antiflatulents
• Foam control in medical and pharmaceutical applications
• Process aid for biofermentation
• ICH Q7 GMP
• FDA registered production site
Description
Description
Description
Polyethylene glycol, PEG
Polyethylene glycol, PEG
Polydimethylsiloxane, PDMS Dimeticone
Silicone antifoam Low volatile
Silicone antifoam Low volatile
Emulsion containing 30 % simeticone
Emulsion containing 30 % simeticone
Grade
Grade
Grade
BP/EP/NF Certificate of suitability (CEP)
BP/EP/NF Certificate of suitability (CEP) application in preparation
Dimeticone EP Certificate of suitability (CEP) Dimethicone NF; US-DMF
Simeticone EP Certificate of suitability (CEP) Simethicone USP; US-DMF
Simeticone EP Certificate of suitability (CEP)
Simethicone Emulsion USP
Simethicone Emulsion USP
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Tereos Starch & SweetenersGlucose Monohydrate Injectable Grade
Product
Meridex™
Meridex™ PF
• Parenteral nutrition, infusion solutions, haemodialysis (HD) and eritoneal dialysis (PD)
• Matches key properties such as purity, flowability and product stability during processing
Description
Glucose monohydrate Tested on bacterial endotoxin (L.A.L test)
Glucose monohydrate Tested on pyrogens (Ph. Eur.)
Grade
Dextrose USP/NF Glucose Monohydrate EP
Dextrose USP/NF Glucose Monohydrate EP
Pharmaceutical Excipients
Avesta PharmaMacrogol
Product
Macrogol 200 Macrogol 400
Macrogol 3350
Macrogol 4000
Macrogol 6000
Macrogols under development 300/600/1000/8000
• Solubility enhancer, non-alcohol diluent
• Filler
• ICH Q7 GMP
Description
Polyethylene glycol, PEG
Polyethylene glycol, PEG
Polyethylene glycol, PEG
Polyethylene glycol, PEG
Polyethylene glycol, PEG
Polyethylene glycol, PEG
Grade
NF
EP/NF
BP/EP/NF Certificate of suitability (CEP)
BP/EP/NF Certificate of suitability (CEP) application in preparation
BP/EP/NF Certificate of suitability (CEP)
EP/NF
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Tereos Starch & Sweeteners Starch
Product
Meritena 141 Pharma
• Quality system based on IPEC-PQG GMP for pharmaceutical excipients
• Solid dosage forms, direct compression, capsules and powders
• Medicated confectionery, hard boiled candies, gums, chewing gums
Description
Maize starch powder/ Corn starch
Grade
Maize Starch EP Corn Starch NF
Dextrose/Glucose
Maltodextrin
Product
Product
Meritose Pharma
Mylose Pharma
Glucomalt Pharma
Glucodry G Pharma
Maldex Pharma
Maldex G Pharma
• Quality system based on IPEC-PQG GMP for pharmaceutical excipients
• Solid dosage forms, direct compression, wet and dry granulation, capsules and powders
• Liquid dosage forms, syrups, solutions, suspensions
• Medicated confectionery, hard boiled candies, gums, chewing gums
• Quality system based on IPEC-PQG GMP guidelines for pharmaceutical excipients
• Solid dosage forms, direct compression, wet and dry granulation, capsules and powders
• Liquid dosage forms, syrups, solutions, suspensions
• Medicated confectionery, hard boiled candies gums, chewing gum
• Clinical nutrition, baby food
Description
Description
Dried D-glucose/dextrose powder-Dextrose monohydrate Range of specific particle sizes
Glucose syrup Dextrose equivalent and sugar spectrum
Glucose syrup Dextrose equivalent and sugar spectrum
Glucose syrup spray-dried Dextrose equivalent and sugar spectrum
Spray-dried maltodextrin powder-Range of specific particle sizes
Spray-dried maltodextrin granulate Range of specific particle sizes
Grade
Grade
Glucose Monohydrate EP Dextrose USP/NF
Glucose Liquid EP Liquid Glucose USP/NF
Glucose Liquid EP Liquid Glucose USP/NF
Glucose liquid spray-dried EP
Maltodextrin EP, USP/NF
Maltodextrin EP, USP/NF
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Polyoles
Product
Merisorb Pharma
Merisorb SD Pharma
Merisorb BEC
Meritol Pharma
Maltilite Pharma
Maltilite P 200 Pharma
• Quality system based on IPEC-PQG GMP for pharmaceutical excipients
• Solid dosage forms, direct compression, wet and dry granulation, capsules and powders
• Liquid dosage forms, syrups, solutions, suspensions
• Medicated confectionery, hard boiled candies gums, chewing gum
Description
Crystallized sorbitol powder (min. 97 % D-sorbit) Range of specific particle sizes
Spray-dried sorbitol powder (min. 97 % D-sorbit) Range of specific particle sizes
Spray-dried sorbitol powder (min. 97 % D-sorbit) Bacterial endotoxin controlled
Crystallising sorbitol syrup Non-crystallising sorbitol syrup
D-Maltitol from maltitiol syrup Range of specific maltitol contents and dry substances
D-Maltitol powder
Grade
Sorbitol EP, USP/NF
Sorbitol EP, USP/NF
Sorbitol EP, USP/NF
Sorbitol Liquid (crystallising) EP Sorbitol Liquid (non-crystallising) EP
Maltitol Liquid EP
Maltitol EP
Tereos Sugar FranceSucrose
Product
Sucrose solution
Compressuc® MS
Compressuc® PS
Alveosucre Fine Grains
Pearl sugar 30
Pure icing sugar
Granulated sugars
Caster sugars
HPLE sucrose
Description
Perfectly clear solution, very low color level
Spray-dried sucrose Anhydrous, easily soluble in water
Spray-dried sucrose Anhydrous, easily soluble in water
Agglomerated sucrose
Agglomerated sucrose
Milled sucrose
Screened sucrose Particle size 600-2000 µm
Screened sucrose Particle size 250/400 µm
Spray-dried sucrose
Grade
Made from USP/NF Sucrose
USP/NF Compressible Sugar
USP/NF Sucrose EP Sucrose
EP Sucrose
EP Sucrose
EP Sucrose
EP Sucrose
EP Sucrose
USP/NF, EP, JP Sucrose
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Sucrose with functional additives
Product
Alveosucre Fine Grains with dextrin
Icing sugar with starch
Icing sugar with silica
• Quality system based on IPEC-PQG GMP for pharmaceutical excipients
• Solid dosage forms, direct compression, wet and dry granulation, capsules, powders and sugar spheres
• Liquid dosage forms, syrups, solutions, suspensions, dry syrups
Description
Agglomerated sucrose + dextrin
Milled sucrose + starch
Milled sucrose + silica
Grade
USP/NF Compressible Sugar
USP/NF Confectioner’s Sugar
Components according to EP monographs
LubricantsStearates
CPKelco - Cellulose DerivativeCarmellose Sodium
Product
Product
Magnesium Stearate
Calcium Stearate
Sodium Stearate
Zinc Stearate Aluminium Stearate Potassium Stearate Stearic Acid 50%/ 70%
Cekol
• Tableting agent
• Lubricant
• Flowability agent
• Separating agent
• Water repellent
• Tablet coating
• Thickener and rheology modifier
• Stabilisation of emulsions and suspensions
Description
Description
Vegetable grade FCC
Vegetable grade FCC
Vegetable grade
Vegetable grade
Vegetable grade
Vegetable grade
Vegetable grade FCC
Carmellose sodium, CMC Available in a wide range of viscosity grades
Grade
Grade
Magnesium Stearate EP/NF
Calcium Stearate NF
Sodium Stearate EP/NF
Zinc Stearate EP/NF
Stearic Acid EP, USP/NF, JP, BP
Carmellose Sodium EP Carboxymethylcellulose NF
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CPKelco - BiogumsXanthan gum
Product
Xantural® 11K
Xantural® 180
Xantural® 75
• Quality system based on IPEC-PQG GMP for pharmaceutical excipients
• Thickener, rheology modifier or gel forming agent
• Stabilisation of emulsions and suspensions
• Controlled drug release formulations
Description
Xanthan gum 14 mesh/1,18 mm particle size
Xanthan gum 80 mesh/180 µm particle size
Xanthan gum 200 mesh/75 µm particle size
Grade
Xanthan Gum EP/NF
Xanthan Gum EP/NF
Xanthan Gum EP/NF
Pectine
Carrageenan
Product
Product
Genu® Pectin
Genugel® CG-130
Genuvisco® CG-131
Genuvisco® CG-129
• Gel forming agent
• Textures from gels to structured fluids
• Used as water-binding and film-forming agents
• Emulsion/suspension stabilization
• Buffer effect to pH 3-5
• Ability to absorb and bind water
• Gel forming agent
• Thickener and rheology modifier
• Stabilisation of emulsions, suspensions and foams
Description
Description
Pectin from citrus peel High ester pectin (DE >50%) Range of specific particle sizes Available in different viscosity grades
Kappa-carrageenan Firm and brittle gels
Iota-carrageenan Elastic and cohesive gels
Lambda-carrageenan Viscous non-gelling solutions
Grade
Grade
Pectin USP
Carrageenan NF
Carrageenan NF
Carrageenan NF
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Gellan Gum
Product
Kelcogel® CG-LA
Kelcogel® CG-HA
• Gel forming agent
• Thickener and rheology modifier
• Fluid-gel forming agent
• Controlled drug release formulations
Description
Gellan gum (low acyl) Firm, non-elastic, brittle gels
Gellan gum (high acyl) Soft, very elastic, non-brittle gels
Grade
Gellan Gum NF
Gellan Gum NF
Yung ZipSodium Starch Glycolate
Product
Sodium Starch Glycolate (DST)Type A
• Superdisintegrant
Description
Sodium carboxymethyl starch type A
Grade
Sodium Starch Glycolate NF/EP/BP
Dow Corning® - SiliconesFluids
Product
Q7-9120 Silicone Fluid 20 cSt 100 cSt 350 cSt 1000 cSt 12500 cSt
ST-Dimethiconol 40
• Skin protectant
• Solubilizer for hydrophilic actives
Description
Dimeticone, polymethylsiloxane (PDMS)
Short, hydroxy-terminated dimeticone
Grade
Dimethicone NF; US-DMF Dimeticone/Silicone Oil EP Certificate of Suitability (CEP)
US-DMF
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Volatiles and Cyclics
Blends
Waxes
Emulsifiers
Product
Product
Product
Product
Q7-9180 Silicone Fluid 0,65 cSt 1 cSt
ST-Cyclomethicone 5-NFST-Cyclomethicone 56-NF
Dimethiconol Blend 20
Silmogen Carrier
ST-Elastomer 10
Silky Wax 10
Emulsifier 10
• Volatile carrier for sprays or semi-solid formulations
• No cooling effect, non-stinging
• Spreading agent
• Semi-occlusive wax
• Thickener for silicone-containing formulations
• Water repellent
• Emulsifier for W/O and W/Si emulsion (up to 80 % water content)
• Room temperature emulsification
Description
Description
Description
Description
Hexamethyldisiloxane (0,65 cSt) Octamethyltrisiloxane (1 cSt)
Cyclopentasiloxan (D5) Cyclopenta-/Cyclohexasiloxan (D5/D6)
Ultra-high viscosity silicone gum (6 %) in non-volatile dimeticone Non occlusive film former
Ultra-high viscosity silicone gum (1 %) in hexamethyldisiloxane Carrier for sprays
Dimeticone crosspolymer (12 %) in cyclometicone (D5) Thickener for silicone containing formulations
Stearyl alcohol and stearoxy trime-thylsilane Melting point 53 °C
Lauryl meticone copolyol
Grade
Grade
Grade
Grade
US-DMF; TF
Cyclomethicone NF US-DMF; TF
US-DMF; TF
US-DMF
US-DMF; TF
US-DMF; TF
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Petroleum Jellies
Fluids
Product
Product
Codex Vaseline
White Oils
TI-1050 Fluids 1.5 cSt
TI-1050 Fluids 5 cSt 10 cSt
TI-1050 Fluids 50 cSt 100 cSt 200 cSt 350 cSt 1,000 cSt
TI-1050 Fluids 12,500 cSt 30,000 cSt 100,000 cSt
• Petroleum Jelly can be used as excipient or as API
• Produced under GMP conditions
• Protective, healing, moisturising and soothing properties
• Non occlusive
• Lubricant
• Spreading agent
Description
Description
Petroleum Jelly
Paraffinum liquidum
Volatile dimeticone Linear polydimethylsiloxane
Low molecular weight dimeticone Linear polydimethylsiloxane Non-volatile
Intermediate molecular weight dimeticone Linear polydimethylsiloxane Non-volatile
High molecular weight dimeticone Linear polydimethylsiloxane Non-volatile
Grade
Grade
EP, French Codex Monograph
EP, USP/NF, BP, French Codex Monograph
Consumer healthcare: topical medical device and OTC - Ingredient Regulatory Information (IRI) - Elemental Impurities
Consumer healthcare: topical medical device and OTC - Ingredient Regulatory Information (IRI) - Elemental Impurities
Consumer healthcare: topical medical device and OTC - Ingredient Regulatory Information (IRI) - Elemental Impurities
Consumer healthcare: topical medical device and OTC - Ingredient Regulatory Information (IRI) - Elemental Impurities
Dow Corning® - Topical IngredientsLow volatile fluids
Product
TI-1010 Fluids 0,65 cSt 1 cSt
• Solubilizer,
• Carrier
• Spreading agent
Description
Volatile dimeticone Linear polydimethylsiloxane
Grade
Consumer healthcare: topical medical device and OTC - Ingredient Regulatory Information (IRI) - Elemental Impurities
12 13
Speciality Fluids
Blends
Product
Product
TI-2011 SPE Specialty Fluid
TI-2021 AMS Specialty Fluid
TI-3011 Gum Blend
TI-3021 Silicone Elastomer Blend
• solubilizer and compatibilizer
• spreading agent
• Non-occlusive
• Emollient
• Non-occlusive
• Improves substantivity
Description
Description
Water dispersible silicone polyether Peg-12 dimethicone Calculated HLB 12
Caprylyl-modified trisiloxane Moderate volatility
Dimeticone and dimeticonol High molecular weight dimeticonol dispersed in a non-volatile carrier film forming agent
Dimeticone and dimeticone crosspolymer Mixture of high molecular weight Cross linked silicone (14 %) in dimeticone 5 cSt rheology modifier
Grade
Grade
Consumer healthcare: topical medical device and OTC - Ingredient Regulatory Information (IRI) - Elemental Impurities
Consumer healthcare: topical medical device and OTC - Ingredient Regulatory Information (IRI) - Elemental Impurities
Consumer healthcare: topical medical device and OTC - Ingredient Regulatory Information (IRI) - Elemental Impurities
Consumer healthcare: topical medical device and OTC - Ingredient Regulatory Information (IRI) - Elemental Impurities
Waxes
Product
TI-4021 Semi-Occlusive Wax
• Structuring agent, semi-occlusive
• helps rheology and texture modification
• broad compatibility with organic and silicone material
Description
C30-45 Alkyldimethylsilyl polypropylsil-sesquioxane Silicone wax with added resin character High melting point +/- 66 °C
Grade
Consumer healthcare: topical medical device and OTC - Ingredient Regulatory Information (IRI) - Elemental Impurities
14 15
Emulsifier
Product
TI-6021 W/O Formulation Aid
• emulsifier for W/O and W/Si emulsion
• produces low viscosity emulsion
• cold or hot processing
Description
PEG-10 dimethicone Silicone polyether copolymer Calculated HLB 4
Grade
Consumer healthcare: topical medical device and OTC - Ingredient Regulatory Information (IRI) - Elemental Impurities
Resins
Product
TI-7012 Solid Resin
TI-7021 Silicone Resin Blend
• Film former
• permeable barrier film
• long lasting film
• excellent wash-off resistance
• non-occlusive
Description
MQ resin polymer Trimethylsiloxysilicate Solventless
MQ siloxane resin diluted in a carrier fluid Dimethicone and trimethylsiloxisilicate
Grade
Consumer healthcare: topical medical device and OTC - Ingredient Regulatory Information (IRI) - Elemental Impurities
Consumer healthcare: topical medical device and OTC - Ingredient Regulatory Information (IRI) - Elemental Impurities
WNC – Ingredients
(Organic-sourced possible)
Topical Ingredients
Functional Ingredient Blends
Product
Vasegreen V, L, B
• Suitable for topical medical devices
• Alternative to Petrolatum, Paraffin and Lanolin
• Customisation possible
• Optimized functional ingredient systems based on the topical ingredients and specific plant actives
• Vegetable-sourced functional ingredients
• Customisation possible
Description
Vegetable-sourced ingredient
Grade
COSMOS certified Organic Certificated Cultivation
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Dr. Andreas LekebuschMarketing Manager PharmaTel: +49 40 [email protected]
Hella KruseProduct ManagerTel: +49 40 [email protected]
Your contact for chemical specialties in Europe
Imprint Published by: Biesterfeld Spezialchemie GmbH – Life Science, HealthcareFerdinandstrasse 41 20095 Hamburg GermanyPhone: +49 40 32008-0 [email protected]
Registered Office: Hamburg, Commercial Register: AG Hamburg, HRB 66970, VAT ID DE196 930 661Managing Directors: Dr. Nicole Hamelau, Peter Wilkes
Our raw material information, data and graphics was obtained from the records of our raw material suppliers.Local availability of products might differ from country to country.
Disclaimer:We shall not be liable for the suitability of the goods for the purpose intended by Customer, unless the achievement of a certain outcome of the utilisation was expressly incorporated into the contract. Our advice, information or recommendations regarding application shall be provided to the best of our knowledge. As the actual application is beyond our scope of influence, and as the circumstances of such application are not completely foreseeable, written and verbal indications, suggestions etc. can only be provided on a non-binding basis. They shall in particular not release Customer from the obligation to examine our products and goods for their suitability with regard to the intended processes and purposes.
Notes
Biesterfeld Spezialchemie GmbH
Ferdinandstraße 4120095 Hamburg / Germany Phone: +49 40 32008-612Fax: +49 40 [email protected]
