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Roquette Dextrose Anhydrous Biopharma

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

Chemical Name: Glucose

CAS Number: 50-99-7

Functions: Cell Culture Nutrient

Certifications & Compliance: Canadian Environmental Protection Act (CEPA), European Pharmacopeia (Ph. Eur.), GMP, Japan Pharmacopeia (JP), United States Pharmacopeia (USP)

Physical Form: Powder, Solid

Synonyms: D-Glucose, D(+)-Glucose, Glucose

Technical Data SheetSafety Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name
Glucose
Pharma & Nutraceuticals Functions
Cell Culture Nutrient
CAS No.
50-99-7
EC No.
200-075-1
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Processing, Purification & Testing Solutions
Cell Culture Solutions

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Pharmaceutical Manufacturing
Other Pharmaceutical Manufacturing Applications

Properties

Physical Form
Powder,
Solid
Appearance
White or almost white, crystalline powder
Typical Properties
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 1ppmFCC
Assay - Reducing Sugars99.5 - 100.5%FCC
Assay (Dextrose)97.5 - 102.0%EP / USP / JP
Chloride Contentmax. 0.018%FCC
Heavy Metalsmax. 4ppmJP
Lead Contentmax. 0.1ppmFCC
Loss on Dryingmax. 2.0%FCC
Optical Specific Rotationmax. 2.0%FCC
Residue on Ignitionmax. 0.1%FCC
Soluble Starch, Sulfitesmax. 15ppmEP / USP / JP
Sulfur Dioxidemax. 0.002%FCC
Total Impuritiesmax. 0.5%EP / USP / JP
Unspecified Impuritiesmax. 0.10%EP / USP / JP
Water Contentmax. 1.0%EP / USP / JP
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coliNot Detectedper gram-
Pseudomonas aeruginosaNot detectedper 10g-
SalmonellaNot Detectedper 10g-
Total Aerobic Microbial Countmax. 100CFU/g-
Total Yeasts and Moulds Countmax. 100CFU/g-

Regulatory & Compliance

Certifications & Compliance
Canadian Environmental Protection Act (CEPA),
European Pharmacopeia (Ph. Eur.),
GMP,
Japan Pharmacopeia (JP),
United States Pharmacopeia (USP)
Chemical Inventories
AICS (Australia),
DSL (Canada),
EINECS (EU),
ENCS (Japan),
IECSC (China),
INSQ (Mexico),
ISHL (Japan),
KECI (Korea),
NZIoC (New Zealand),
PICCS (Phillipines),
TCSI (Taiwan),
TSCA (USA)
Grade
Pharma Grade
Quality Standards
ICH Q7
Conformity

Conforms to the current edition of 

  • European Pharmacopeia (EP), GLUCOSE (0177)
  • US Pharmacopeia (USP)
  • DEXTROSE - Japanese Pharmacopeia (JP)
  • PURIFIED GLUCOSE - Food Chemical Codex (FCC), DEXTROSE

Packaging & Availability

Packaging Information
  • Article (SKU) Code: 5100002217
  • Package Size & Type: 12 KG POWDER DRUM

Storage & Handling

Shelf Life
3 Years
Storage and Handling

Those date is indicative and may vary according to packaging type and manufacturing plant. Proper information is shown on labeling and CoA. We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations of temperature and humidity. Upon opening, use the product as quickly as possible to prevent moisture regain.