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Roquette Dextrose Anhydrous Biopharma

Sold by Roquette
Supplier:  Roquette

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
Function: Cell Culture Nutrient
Certifications & Compliance: United States Pharmacopeia (USP), Japan Pharmacopeia (JP), Canadian Environmental Protection Act (CEPA), GMP, European Pharmacopeia (Ph. Eur.)
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Identification & Functionality

Applications & Uses

Properties

Physical Form
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

Conformity

Conforms to the current edition of 

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

Packaging & Availability

Packaging Information
  • ROQ Product Code: 361417
  • Article (SKU) Code: 361417102
  • Package Size & Type: 12 kg lined PE 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 labelling 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.

Most Viewed Documents

Document Name
Type
Products
Roquette Dextrose Anhydrous Biopharma Technical Data Sheet
Technical Data Sheet
Roquette Dextrose Anhydrous Biopharma
Technical Data Sheet
Products: Roquette Dextrose Anhydrous Biopharma
Roquette Dextrose Anhydrous Biopharma Safety Data Sheet (US - EN)
Safety Data Sheet
Roquette Dextrose Anhydrous Biopharma
Safety Data Sheet
Products: Roquette Dextrose Anhydrous Biopharma
Roquette DEXTROSE ANHYDROUS BIOPHARMA Safety Data Sheet (REC - ES)
Safety Data Sheet
Roquette Dextrose Anhydrous Biopharma
Safety Data Sheet
Products: Roquette Dextrose Anhydrous Biopharma
Roquette DEXTROSE ANHYDROUS BIOPHARMA Safety Data Sheet (REC - PT)
Safety Data Sheet
Roquette Dextrose Anhydrous Biopharma
Safety Data Sheet
Products: Roquette Dextrose Anhydrous Biopharma
Roquette DEXTROSE ANHYDROUS BIOPHARMA Safety Data Sheet (REC - EN)
Safety Data Sheet
Roquette Dextrose Anhydrous Biopharma
Safety Data Sheet
Products: Roquette Dextrose Anhydrous Biopharma