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NEOSORB® BIOPHARMA - SORBITOL

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.

Brand: NEOSORB (9 products)

Chemical Name: D-Glucitol

Functions: Stabilizer, Sweetener

CAS Number: 50-70-4

Synonyms: D-Sorbitol, D-Sorbol, Diakarmon, G-ol, Glc-ol, Glucarine, Karion, Multitol, Sionit, Sionite, Sorbilande

Technical Data SheetSafety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name
D-Glucitol
Pharma & Nutraceuticals Functions
Stabilizer,
Sweetener
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Emulsifiers & Stabilizers,
Flavors & Taste Maskers,
Formulation & Processing Aids
Chemical Structure

NEOSORB® BIOPHARMA - SORBITOL - Chemical Structure

Features & Benefits

Key Attributes
  • Solution for protein stabilization
  • Multi-compendial
  • Sole custody of the supply chain
  • Very high purity, Low endotoxin, For application in BioPharma

Applications & Uses

Markets
Food & Nutrition,
Healthcare & Pharma
Applications
Food & Nutrition — Nutrition & Well Being
Nutraceuticals & Supplements
Healthcare & Pharma — Pharmaceutical Manufacturing
Pharmaceutical Processing
Recommended Applications

NEOSORB® Biopharma low endoxin sorbitol provides protein stabilization in biopharmaceutical downstream applications. Known for its high water solubility, it is a proven formulation aid for biopharmaceuticals.

Properties

Physical Form
Powder
Soluble In
Water Soluble
Soluble in
Water
Insoluble in
Ethanol, Chloroform, Diethyl Ether.
Typical Properties
ValueUnitsTest Method / Conditions
Average Molecular Weight182.2g/mol
Assay (on Ds)min. 98%ChP
Water Content (LOD)max. 1.5%
Specific Optical Rotation4 - 7°ChP
Minimum Melting Temperature95°C
Residue on Ignitionmax. 0.1%ChP
Maximum Melting Temperature98°C
D-Mannitolmax. 2.0%ChP
Glass Transition Temperature of the Cryo-Concentrated Phase Tg-44°C
D-Iditolmax. 2.0%ChP
D-Maltitolmax. 2.0%ChP
Amount of Related Substancesmax. 3%ChP
Chloridemax. 0.005%ChP
Sulfatemax. 0.01%(w/w)ChP
Heavy Metalsmax. 10mg/kgChP
Arsenicmax. 2mg/kgChP
Loss on Dryingmax. 1%ChP
Microbiological Values
ValueUnitsTest Method / Conditions
Total Aerobic Microbial Countmax. 100CFU/g-
Total Yeasts and Molds Countmax. 100CFU/g-
Escherichia ColiNot detected in 1g--
SalmonellaNot detected in 10g--
Bacterial Endotoxinsmax. 2.5IU/g-
Solubility Information
  • Very soluble in water (235 g/100 ml of water at 25°C)
  • Practically insoluble in ethanol (96%)

Regulatory & Compliance

Certifications & Compliance
Chinese Pharmacopeia (ChP),
European Pharmacopeia (Ph. Eur.),
Japan Pharmacopeia (JP),
National Formulary (NF),
United States Pharmacopeia (USP)
Chemical Inventories
TSCA (USA)
Grade
Pharma Grade

Technical Details & Test Data

Water Sorption Isotherm at 20°C

NEOSORB® BIOPHARMA - SORBITOL - Water Sorption Isotherm At 20°C

Osmolality

NEOSORB® BIOPHARMA - SORBITOL - Osmolality

Packaging & Availability

Packaging Type
Bags
Packaging Information
  • Article (SKU) Code: 5100000950
  • Package Size & Type: 12 KG POWDER DRUM