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PEARLITOL® 200 SD Mannitol - Pharma
Chemical Name:
D-mannitol
CAS Number:
69-65-8
Functions:
Binder, Filler
Dosage Form:
Orally Disintegrating Tablets (ODTs), Granules, Tablets, Powder & Powder Blends, Capsules
Labeling Claims:
Kosher, Halal, Vegan, Non-GMO, Sugar-free, Melamine-free, Acrylamide-free, BSE-free, Non-Carcinogenic, TSE-free
Certifications & Compliance:
GMP, Kosher, FSSAI, Halal, FDA IID, United States Pharmacopeia (USP), FSSC 22000, Chinese Pharmacopeia (ChP), European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), ISO 9001, EXCiPACT
Synonyms:
1,2,3,4,5,6-Hexanehexol, Cordycepic Acid, D-(-)-Mannitol, Manicol, Manitol
PEARLITOL® Mannitol is used in pharmaceutical and nutraceutical formulations as a filler, filler/binder and bulk sweetener in various oral dosage applications. Applications Swallowable, orally dispersible, chewable and effervescent tablets Lozenges Blends Granules Pellets premix Medicated confectionery Features Unique blend of exceptional physical and chemical stability and no hygroscopicity Directly compressible crystalline range with various particle sizes Great organoleptic, non-cariogenic and sugar-free properties Suitable for use in formulations addressing pediatric and diabetic patient populations
PEARLITOL® 100 SD Mannitol - Pharma
Chemical Name:
D-mannitol
Functions:
Binder, Filler
CAS Number:
69-65-8
Dosage Form:
Orally Disintegrating Tablets (ODTs), Tablets, Capsules
Labeling Claims:
BSE-free, Halal, Vegan, Non-GMO, Acrylamide-free, TSE-free, Kosher
Certifications & Compliance:
ISO 9001, Halal, FDA IID, United States Pharmacopeia (USP), EXCiPACT, Chinese Pharmacopeia (ChP), European Pharmacopeia (Ph. Eur.), GMP, Japan Pharmacopeia (JP), Kosher
Synonyms:
1,2,3,4,5,6-Hexanehexol, Cordycepic Acid, D-(-)-Mannitol, Manicol, Manitol
PEARLITOL® Mannitol pharma range is used in pharmaceutical and nutraceutical formulations as a filler, filler/binder and bulk sweetener in oral dosage form applications. Applications Swallowable, orally dispersible, chewable and effervescent tablets Lozenges Blends Granules Pellets premix Medicated confectionery Features Unique blend of exceptional physical and chemical stability and no hygroscopicity Directly compressible crystalline range with various particle sizes Great organoleptic, non-cariogenic and sugar-free properties Suitable for use in formulations addressing pediatric and diabetic patient populations
Roquette Dextrose Anhydrous Biopharma
Chemical Name:
Glucose
CAS Number:
50-99-7
Functions:
Cell Culture Nutrient
Certifications & Compliance:
European Pharmacopeia (Ph. Eur.), Canadian Environmental Protection Act (CEPA), GMP, Japan Pharmacopeia (JP), United States Pharmacopeia (USP)
Physical Form:
Solid, Powder
Synonyms:
D-Glucose, D(+)-Glucose, Glucose
Roquette Dextrose Anhydrous BioPharma is used upstream in the cell culture process as an energy and carbon source during the production of therapeutic proteins. Features In-process quality controls ensure a consistent supply of raw materials and excipients Integrated supply chain reduces the risks associated in biopharmaceutical manufacturing Multi-compendial material - USP, EP, JP
SOLUTAB® A Croscarmellose Sodium - Pharma
Chemical Name:
Croscarmellose Sodium
Functions:
Disintegrant
Certifications & Compliance:
FDA IID, National Formulary (NF), United States Pharmacopeia (USP), FSSAI, Kosher, FSSC 22000, ISO 9001, Halal, European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP)
Labeling Claims:
BSE-free, TSE-free, Kosher, Halal, Vegan
Synonyms:
E468, Sodium Croscarmellose
SOLUTAB® Croscarmellose sodium is used in pharmaceutical and nutraceutical applications as a superdisintegrant for various oral dosage forms. Applications Swallowable tablets Orally dispersible tablets Hard capsules Blends Granules Pellets premix Benefit Efficient disintegration at low use level Features Crosslinked carboxymethyl cellulose sodium Three grades are available Disintegration performance is obtained through the wicking and swelling capacity that can be maximized via the selection of its origin (wood or cotton) Can be adapted to wet and dry granulation or direct compression processes
LYCATAB® C Partially Pregelatinized Starch - Pharma
Chemical Name:
Starch, Pregelatinized
Functions:
Binder, Filler, Disintegrant
Certifications & Compliance:
United States Pharmacopeia (USP), Chinese Pharmacopeia (ChP), FSSAI, Kosher, FSSC 22000, ISO 9001, Halal, GMP, European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP)
Labeling Claims:
BSE-free, TSE-free, Melamine-free, Acrylamide-free, Kosher, Halal, Vegan, Non-GMO
LYCATAB® C partially pregelatinized starch is used in pharmaceutical and nutraceutical applications as a multifunctional for oral dosage forms. Applications gelatin capsules as a filler direct compression applications as a filler/binder swallowable tablets and hard capsules as a filler/binder/disintegrant Features Combines the disintegration power of starch granules with the high cohesion and good compressibility of pregelatinized starch Due to limited flow properties, often requires the use of additional excipients and production steps such as granulation or partial pregelatinization
PEARLITOL® 300 DC Mannitol - Pharma
Chemical Name:
D-mannitol
CAS Number:
69-65-8
Functions:
Binder, Filler
Dosage Form:
Orally Disintegrating Tablets (ODTs), Granules, Tablets, Powder & Powder Blends, Capsules
Labeling Claims:
Kosher, Halal, Vegan, Non-GMO, Sugar-free, Melamine-free, Acrylamide-free, BSE-free, Non-Carcinogenic, TSE-free
Certifications & Compliance:
GMP, Kosher, FSSAI, Halal, FDA IID, United States Pharmacopeia (USP), FSSC 22000, Chinese Pharmacopeia (ChP), European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), Canadian Environmental Protection Act (CEPA), ISO 9001, EXCiPACT
Synonyms:
1,2,3,4,5,6-Hexanehexol, Cordycepic Acid, D-(-)-Mannitol, Manicol, Manitol
PEARLITOL® Mannitol pharma range is used in pharmaceutical and nutraceutical formulations as a filler, filler/binder and bulk sweetener in various oral dosage applications. Applications Swallowable, orally dispersible, chewable and effervescent tablets Lozenges Blends Granules Pellets premix Medicated confectionery Features Unique blend of exceptional physical and chemical stability and no hygroscopicity Directly compressible crystalline range with various particle sizes Great organoleptic, non-cariogenic and sugar-free properties Suitable for use in formulations addressing pediatric and diabetic patient populations
PEARLITOL® 50 C Mannitol - Pharma
Chemical Name:
Mannitol
Functions:
Filler, Sweetener, Binder
CAS Number:
87-78-5
Dosage Form:
Tablets, Granules, Orally Disintegrating Tablets (ODTs), Capsules, Powder & Powder Blends
Labeling Claims:
Non-Carcinogenic, Halal, Vegan, Acrylamide-free, Sugar-free, Melamine-free, Kosher
Synonyms:
1,2,3,4,5,6-Hexanehexol, Cordycepic Acid, Manicol, Manitol
PEARLITOL® Mannitol pharma range is used in pharmaceutical and nutraceutical applications as a filler, filler/binder and bulk sweetener for various oral dosage forms. Applications Swallowable, orally dispersible, chewable and effervescent tablets, Lozenges Blends Granules Pellets premix Medicated confectionery Benefit Suitable for use in formulations addressing all types of patient populations, including pediatric and diabetic Features Directly compressible Unique blend of exceptional physical and chemical stability No hygroscopicity Organoleptic, non-cariogenic and sugar-free properties
MICROCEL® MC-102 Microcrystalline Cellulose - Pharma
Chemical Name:
Cellulose, Microcrystalline
Functions:
Binder, Filler
Certifications & Compliance:
FDA IID, United States Pharmacopeia (USP), Kosher, ISO 9001, Halal, European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP)
Labeling Claims:
BSE-free, TSE-free, Pesticide-free, Kosher, Halal, Vegan
Synonyms:
Crystalline cellulose, Micro Fibril Cellulose, Pyrocellulose
MICROCEL® Microcrystalline cellulose is used in pharmaceutical and nutraceutical applications as a filler/binder and fiber source in various oral dosage forms. Applications Swallowable tablets Hard capsules Blends Granules Pellets premix Features Available in a large range to meet different formulation, process and dosage form requirements Large surface area allows adsorption of particles or liquids and a certain capacity to act as a disintegrant Spray dried and offered from EXCiPACT (International Pharmaceutical Excipients Certification) certified plant
Roquette 400L-NF Corn Starch - Pharma
Chemical Name:
Corn Starch, Modified
Functions:
Binder, Filler, Disintegrant
Certifications & Compliance:
FDA IID, National Formulary (NF), United States Pharmacopeia (USP), DMF Type II, FSSAI, Kosher, FSSC 22000, ISO 9001, Halal, European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP)
Labeling Claims:
BSE-free, TSE-free, Melamine-free, Acrylamide-free, Kosher, Halal, Vegan
Roquette 400L-NF Corn Starch is an oxidized maize starch that can be used as a disintegrant filler and binder (once cooked) in a variety of nutraceutical and pharmaceutical dosage forms, including swallowable tablets, hard capsules, blends, granules and pellets premix. Benefits Acrylamide-free BSE-free Halal and Kosher certified Melamine-free TSE-free Vegan
MICROCEL® MC-101 Microcrystalline Cellulose - Pharma
Chemical Name:
Cellulose, Microcrystalline
Functions:
Binder, Filler
Certifications & Compliance:
FDA IID, United States Pharmacopeia (USP), Kosher, ISO 9001, Halal, European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP)
Labeling Claims:
BSE-free, TSE-free, Pesticide-free, Kosher, Halal, Vegan
Synonyms:
Crystalline cellulose, Micro Fibril Cellulose, Pyrocellulose
MICROCEL® Microcrystalline cellulose is used in both pharmaceutical and nutraceutical applications as a filler/binder and fiber source in various oral dosage forms. Applications Swallowable tablets Hard capsules Blends Granules Pellets premix Features Available in a large range to meet different formulation, process and dosage form requirements Large surface area allows adsorption of particles or liquids and a certain capacity to act as a disintegrant Spin flash-dried
NEOSORB® P 300 C Sorbitol - Pharma
Chemical Name:
D-Glucitol
Functions:
Binder, Filler
Certifications & Compliance:
Canadian Environmental Protection Act (CEPA), United States Pharmacopeia (USP), European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP)
Labeling Claims:
Non-Carcinogenic, Sugar-free
Synonyms:
D-Sorbitol, D-Sorbol, Diakarmon, G-ol, Glc-ol, Glucarine, Karion, Multitol, Sionit, Sionite, Sorbilande
NEOSORB® Sorbitol pharma is used in pharmaceutical and nutraceutical formulations as a filler, filler/binder and bulk sweetener in various oral dosage applications, and as a plasticizing agent well-adapted to starches in coating/film forming applications. Applications Swallowable, orally dispersible, chewable and effervescent tablets Lozenges Blends Granules Pellets premix Medicated confectionery Features Excellent tableting properties Great organoleptic, non-cariogenic and sugar-free properties Suitable for use in formulations addressing pediatric and diabetic patient populations
GLYCOLYS® Low Solvent Sodium Starch Glycolate - Pharma
Chemical Name:
Sodium Carboxymethyl Starch
Functions:
Disintegrant
Certifications & Compliance:
FDA IID, National Formulary (NF), United States Pharmacopeia (USP), FSSAI, Kosher, FSSC 22000, Canadian Environmental Protection Act (CEPA), ISO 9001, Halal, European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP)
Labeling Claims:
BSE-free, TSE-free, Kosher, Halal, Vegan
Synonyms:
Carboxymethyl starch sodium salt, Sodium starch glycolate
GLYCOLYS® Low Solvent Sodium Starch Glycolate is a superdisintegrant for pharmaceutical and nutraceutical swallowable tablets, orally dispersible tablets and hard capsules. Features Different grades designed to meet specific needs: Withstanding high shear granulation Acidic conditions Low organic solvent content
XYLISORB® 300 Xylitol - Pharma
Chemical Name:
Xylitol
Functions:
Sweetener, Binder, Filler, Film Former, Coating System
Certifications & Compliance:
United States Pharmacopeia (USP), ISO 50001, Kosher, ISO 9001, Halal, GMP, European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), EXCiPACT
Labeling Claims:
Vegetarian, Kosher, Halal, Vegan, Sugar-free, Non-GMO, Low Calorie
Synonyms:
Eutrit, Fluorette, L-Xylitol, Meso-Xylitol, Wood Sugar Alcohol, Xylisorb, Xylitab 100, Xylitab DC, Xylitol C
XYLISORB® Xylitol powders can be used in pharmaceutical and nutraceutical applications as a filler, filler/binder and bulk sweetener that provides nutrient benefits. Applications Swallowable tablets Medicated confectionaries Features Five-carbon polyol with a characteristic crystalline shape Low calorie sugar-free ingredient with high natural sweetness Suitable for use in formulations addressing pediatric and diabetic patient populations
Beauté by Roquette® PO 370 Polyol
INCI Name:
Xylitol
Ingredient Origin:
Non-Animal Origin, Natural Origin, Plant Origin
Functions:
Sweetener, Humectant, Moisturizing Agent, Exfoliant (Physical), Bacteriostatic Agent, Oral Care Agent
Labeling Claims:
Credo Clean Standard, Clean at Sephora, Biodegradable, Naturally Derived, Kosher, Natural, Vegan, Ulta Beauty's Conscious Beauty, Plant-Based, Odor-free, Halal
Certifications & Compliance:
EU Cosmetic Regulation 1223/2009 Compliant, ISO 16128, Kosher, COSMOS, NaTrue, IECIC (China), FDA Compliant, Japan Pharmacopeia (JP), Halal
Benefit Claims:
Humectancy, Moisturizing, Promotes Oral Health, Chemical Stability, Sensory Enhancement, Thermal Stability, Specific Sensory Performance, Remineralizing, Antimicrobial
Beauté by Roquette® PO 370 is a moisturizing agent that can be used in: daily facial washes, as a mild scrubbing agent flavored lipsticks, to improve overall sensorial experience by providing sweetness or masking a bitter taste oral care products, to aid in tooth remineralisation and tooth decay prevention Features High solubility in water (about 64g/100g water) Large particle size Excellent thermal and chemical stability Reduces microbial growth Reduces chemical reactions and enzyme activity in the final product Sweet flavor
Roquette Dextrose Anhydrous C - Pharma
Functions:
Binder, Filler
Certifications & Compliance:
United States Pharmacopeia (USP), European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), EXCiPACT
Labeling Claims:
Low Water Content, Natural
Dosage Form:
Tablets
Dextrose Anhydrous is a sugar carbohydrate used for as a filler and a carbohydrate source in pharma oral dosage and nutraceutical forms, including swallowable tablets, chewable tablets, effervescent tablets and medicated confectionaries. Features Monomer of natural starch polymer that is also the natural physiological sugar in the human body Provides key excipient and nutrient benefits Natural low water content compared to dextrose monohydrate t High stability Available as a range of products to meet application requirements of manufacturers
Roquette POWDERED NF CORN STARCH
Chemical Name:
Corn Starch
Functions:
Binder, Disintegrant, Filler
Certifications & Compliance:
Kosher, FDA IID, National Formulary (NF), United States Pharmacopeia (USP), ISO 9001, Halal, European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP)
Labeling Claims:
Kosher, Halal
Roquette powdered NF corn starch is used in pharmaceutical and nutraceutical formulations as a disintegrant, filler and binder (once cooked). Applications Swallowable tablets Hard capsules Blends Granules Pellets premix
StarLac® Lactose Monohydrate & Maize Starch Compound
Chemical Name:
Lactose Monohydrate, Corn Starch
Functions:
Binder, Disintegrant, Filler
Dosage Form:
Capsules, Orally Disintegrating Tablets (ODTs), Granules, Tablets
Certifications & Compliance:
National Formulary (NF), United States Pharmacopeia (USP), Japan Pharmacopeia (JP), European Pharmacopeia (Ph. Eur.)
StarLac® Co-processed lactose starch is a filler/binder with strong disintegrant properties. The co-processing offers superior benefit compared to a blend of lactose and starch. It allows to improve the performance (hardness, friability, disintegration time) of your formulation. Specifically designed for direct compression applications, StarLac® is also an excellent filler/binder in dry granulation processes. StarLac® can be used in various oral dosage forms in pharmaceutical applications including granules, swallowable tablets, orally dispersible tablets and hard capsules.
PEARLITOL® 160 C - Mannitol
Chemical Name:
D-mannitol
Functions:
Sweetener, Binder, Filler
CAS Number:
69-65-8
Dosage Form:
Tablets, Granules, Orally Disintegrating Tablets (ODTs), Powder & Powder Blends, Capsules
Labeling Claims:
Non-Cariogenic, Sugar-free
Synonyms:
1,2,3,4,5,6-Hexanehexol, Cordycepic Acid, D-(-)-Mannitol, Manicol, Manitol
PEARLITOL® Mannitol pharma range is used as a filler and filler/binder. The PEARLITOL® range offers a unique blend of exceptional physical and chemical stability with no hygroscopicity. Using different texturizing technologies, we have designed a crystalline range of directly compressible PEARLITOL® with various particle sizes, allowing you to find the right product. With great organoleptic, non-cariogenic, and sugar-free properties. PEARLITOL® is suitable to be used in formulations addressing all types of patient populations, including paediatrics and diabetics. PEARLITOL® can be used in various oral dosage forms in both pharmaceutical and nutraceutical applications, including swallowable tablets, orally dispersible tablets, chewable tablets, effervescent tablets, lozenges, blends, granules, pellet premixes, and medicated confectionary.
PEARLITOL® 200 GT-EXP
Chemical Name:
Mannitol
CAS Number:
87-78-5
Functions:
Filler, Sweetener, Binder
Dosage Form:
Pellets, Tablets, Orally Disintegrating Tablets (ODTs), Other Dosage Forms, Powder & Powder Blends, Lozenges
Labeling Claims:
Non-Cariogenic
Synonyms:
1,2,3,4,5,6-Hexanehexol, Cordycepic Acid, Manicol, Manitol
PEARLITOL® 200 GT-EXP is a direct compression excipient specifically formulated to enhance the manufacturing process of tablets. This exceptional excipient is designed to address key challenges such as capping, while improving flowability and tabletability. PEARLITOL® 200 GT-EXP is a granulated form of mannitol known for its outstanding physical and chemical stability. With its high API compatibility and non-hygroscopic nature, it ensures consistent quality and performance in pharmaceutical formulations. As a non-cariogenic and non-acidogenic sugar-free sweetener, it is suitable for various patient populations, including pediatric and diabetic individuals. PEARLITOL® 200 GT-EXP finds application in a wide range of dosage forms, including tablets (lozenges, swallowable, orally dispersible, chewable, and effervescent) as well as powder blends (sachets, oral stick packs, and hard gelatin capsules).
PEARLITOL® Flash Mannitol - Pharma
Functions:
Disintegrant, Binder, Filler
Dosage Form:
Orally Disintegrating Tablets (ODTs), Tablets
Labeling Claims:
Kosher, Non-Hazardous, BSE-free, Halal, Vegan, Non-GMO, Melamine-free, TSE-free
Certifications & Compliance:
FDA Compliant, GMP, Japan Pharmacopeia (JP), Kosher, ISO 9001, Halal, United States Pharmacopeia (USP), EXCiPACT, ISO 50001, European Pharmacopeia (Ph. Eur.)
PEARLITOL® Flash is used in nutraceutical and pharma oral dosage forms as a filler/binder for orally dispersable tablets. Applications Fast disintegrating tablets Orally dispersible tablets Benefits Excipient functional properties Disintegrant benefit Simplifies tablet formulation Features Compound of mannitol and starch adapted to direct compression formulation Excellent chemical inertness Consistent rapid disintegration under any compression force
PEARLITOL® PF Mannitol Pyrogen Free - Pharma
Chemical Name:
Mannitol
CAS Number:
87-78-5
Functions:
Isotonic Agent, Diuretic, Bulking Agent, Osmotic Agent
Dosage Form:
Injectables, Powder & Powder Blends
Labeling Claims:
Halal, Vegan, Non-GMO, Melamine-free, Pyrogen-free, BSE-free, TSE-free, Kosher, Non-Hazardous
Certifications & Compliance:
Halal, United States Pharmacopeia (USP), European Pharmacopeia (Ph. Eur.), FDA Compliant, Japan Pharmacopeia (JP), ISO 9001, Indian Pharmacopeia, EXCiPACT, ISO 50001, GMP, Kosher
Synonyms:
1,2,3,4,5,6-Hexanehexol, Cordycepic Acid, Manicol, Manitol
PEARLITOL® PF is a pyrogen-free mannitol that is used for parenteral preparations and Rx injectables. Applications Osmotic diuretic agent in small and large volume parenteral injectables Isotonic agent and bulking agent for freeze-dried powder for Rx injection or infusion Pharmaceutical API used to reduce elevated pressure in the brain (cerebral oedema) and in the eyes (note: production has to comply with the internationally accepted GMP standards)
NEOSORB® BIOPHARMA - SORBITOL
Chemical Name:
D-Glucitol
Functions:
Sweetener, Stabilizer
CAS Number:
50-70-4
Synonyms:
D-Sorbitol, D-Sorbol, Diakarmon, G-ol, Glc-ol, Glucarine, Karion, Multitol, Sionit, Sionite, Sorbilande
NEOSORB® BioPharma Low endotoxin grade sorbitol provides protein stabilization in your biopharmaceutical downstream applications. Known for its high water solubility, it is a proven formulation aid for biopharmaceuticals. Sorbitol is used as an excipient in over 35 commercial mAbs, therapeutic proteins and vaccines. Roquette's in process quality controls ensure a consistent supply of raw materials and excipients to help bring your biologics to life. Through our integrated supply chain and rigorous quality systems, we reduce the risks associated in biopharmaceutical manufacturing. NEOSORB® BioPharma is suitable for use in biopharmaceutical manufacturing and as an excipient for injectable dosage forms. Contact us today to talk about our multi-compendial materials - EP, JP, and USP.
PEARLITOL® CR-H - HYPROMELLOSE – MANNITOL
Chemical Name:
Mannitol, Hydroxypropyl Methylcellulose
Functions:
Binder, Controlled Release Agent
Dosage Form:
Lozenges, Tablets
Certifications & Compliance:
National Formulary (NF), United States Pharmacopeia (USP), Japan Pharmacopeia (JP), Chinese Pharmacopeia (ChP), FDA 29 CFR 1910.1200, European Pharmacopeia (Ph. Eur.)
PEARLITOL® CR-H - HYPROMELLOSE – MANNITOL is a combination of hypromellose (HPMC) and mannitol that offers excipient functional properties for tablet formulations. It serves as a binder while also providing controlled release characteristics. Specifically designed for direct compression formulations, Pearlitol® CR-H is suitable for use in oral tablets for both pharmaceutical and nutraceutical applications that require controlled properties.
POLYSORB® PA
Chemical Name:
Isosorbide
Functions:
Intermediate
CAS Number:
652-67-5
Chemical Family:
Diols, Alcohols, Polyols
Compatible Polymers & Resins:
Polyurethanes (PU), Polyesters
POLYSORB® PA is a high purity grade of isosorbide grade under pellets form (POLYSORB® PA). It offers valuable solutions to performance materials markets: polyesters, composites and coatings, polyurethanes, etc. Key benefits Temperature resistance Optical properties Surface hardness
GLYCOLYS® Sodium Starch Glycolate - Pharma
Chemical Name:
Sodium Carboxymethyl Starch
Functions:
Disintegrant
Certifications & Compliance:
United States Pharmacopeia (USP), ISO 50001, FDA Compliant, Chinese Pharmacopeia (ChP), Kosher, ISO 9001, Halal, GMP, European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), EXCiPACT
Labeling Claims:
BSE-free, TSE-free, Melamine-free, Kosher, Non-Hazardous, Halal, Vegan, Non-GMO
Synonyms:
Carboxymethyl starch sodium salt, Sodium starch glycolate
GLYCOLYS® Sodium Starch Glycolate is a superdisintegrant for pharmaceutical applicationbs such as swallowable tablets, orally dispersible tablets and hard capsules. Benefits BSE-free Halal and Kosher certified Melamine-free Non-GMO Non-hazardous TSE-free Vegan Features Free of off-odors Low ethanol content
NEOSORB® P 300 SD Sorbitol - Pharma
Chemical Name:
D-Glucitol
Functions:
Sweetener, Binder, Filler, Plasticizer
Certifications & Compliance:
United States Pharmacopeia (USP), European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP)
Labeling Claims:
Non-Hazardous, Non-Carcinogenic, Sugar-free
Synonyms:
D-Sorbitol, D-Sorbol, Diakarmon, G-ol, Glc-ol, Glucarine, Karion, Multitol, Sionit, Sionite, Sorbilande
NEOSORB® XTAB 300S is a directly compressible sorbitol powder that can be used for very hard, sugar-free tablets with high flavor load. Benefits Delivers a smooth, hard and uniform colored surface Provides a clean, cooling effect Does not produce acids or cause dental plaque or tooth decay Nutritional benefits (maintenance of tooth mineralization, tooth-friendly generic EU claims) recognized by European regulations Features Non-cariogenic Sugar-free
PEARLITOL® SW-F 200 - MANNITOL - USP/NF
Chemical Name:
Mannitol
Functions:
Binder, Filler
CAS Number:
87-78-5
Dosage Form:
Lozenges, Granules, Tablets, Pellets
Labeling Claims:
Non-Carcinogenic, Halal, Vegan, Sugar-free, Natural, Plant-Based, Kosher, Naturally Derived
Certifications & Compliance:
ISO 9001, Halal, National Formulary (NF), United States Pharmacopeia (USP), FSSC 22000, FCC Compliant, Hazard Analysis Critical Control Point (HACCP), Vegan, Japan Pharmacopeia (JP), Kosher, Generally Recognized As Safe (GRAS)
Synonyms:
1,2,3,4,5,6-Hexanehexol, Cordycepic Acid, Manicol, Manitol
PEARLITOL® Mannitol pharma range is used as a filler and filler/binder. The PEARLITOL® range offers a unique blend of exceptional physical and chemical stability and no hygroscopicity. Using different texturizing technologies we have designed a crystalline range of directly compressible PEARLITOL® with various particle size allowing you to find the right product. With great organoleptic, non-cariogenic and sugar-free properties PEARLITOL® is suitable to be used in formulation addressing all type of patient population including pediatric and diabetic. PEARLITOL® can be used in in various oral dosage forms in both pharmaceutical and nutraceutical applications including swallowable tablets, orally dispersible tablets, chewable tablets, effervescent tablets, lozenges, blends, granules, pellets premix and medicated confectionary
PEARLITOL® 25 C Mannitol - Pharma
Chemical Name:
D-mannitol
CAS Number:
69-65-8
Functions:
Binder, Filler, Sweetener
Dosage Form:
Powder & Powder Blends, Lozenges, Tablets, Granules, Orally Disintegrating Tablets (ODTs), Pellets
Labeling Claims:
Kosher, TSE-free, BSE-free, Non-Carcinogenic, Halal, Vegan, Non-Hazardous, Sugar-free, Melamine-free
Synonyms:
1,2,3,4,5,6-Hexanehexol, Cordycepic Acid, D-(-)-Mannitol, Manicol, Manitol
PEARLITOL® 25 C Mannitol is a filler and bulk sweetener that can be used for pharmaceutical oral dosage applications. Benefits BSE-free Halal and Kosher certified Melamine-free Non-carcinogenic Non-hazardous Sugar-free TSE-free Vegan Features High physical and chemical stability Cooling effect Non-cariogenic Low hygroscopicity
KLEPTOSE® HPB Biopharma Hydroxypropyl Betadex
Chemical Name:
(2-Hydroxypropyl)-β-cyclodextrin
Functions:
Stabilizer, Encapsulant
Certifications & Compliance:
United States Pharmacopeia (USP), GMP, European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP)
Labeling Claims:
Pyrogen-free
Synonyms:
2-Hydroxypropyl-Beta-Cyclodextrin, beta-Cyclodextrin 2-Hydroxypropyl Ethers, HPBCD, HPbetaCD, HPCD, Hydroxypropyl Betadex, Hydroxypropyl-Beta-Cyclodextrin
KLEPTOSE® HPB Biopharma Hydroxypropyl Betadex is a low endotoxin grade materials that provides protein stabilization for biopharmaceutical downstream applications. With a hydrophobic internal cavity and hydrophilic exterior, KLEPTOSE® HPB BioPharma can encapsulate molecules, forming inclusion complexes where lipophilic compounds are non-covalently bound within the cavity. It is suitable for use in biopharmaceutical manufacturing and as an excipient for injectable dosage forms. Benefits Unique ability to encapsulate and shield water insoluble materials can be utilized to shield exposed hydrophobic residues on aggregation-prone proteins, thereby modulating protein aggregation Shows promise as a multifunctional excipient suitable for biopharma applications Can serve as a tool to synergistically complement biotherapeutic formulations Multicompendial material (EP, USP, JP) Features Starch derivative Cyclic oligosaccharide with a bucket-like structure