Roquette Dextrose Anhydrous Biopharma
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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
CAS Number: 50-99-7
Function: Cell Culture Nutrient
Certifications & Compliance: Japan Pharmacopeia (JP), United States Pharmacopeia (USP), GMP, Canadian Environmental Protection Act (CEPA), European Pharmacopeia (Ph. Eur.)
Physical Form: Powder, Solid
Synonyms: D-Glucose, D(+)-Glucose, Glucose
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TypeDocument Name
Technical Data Sheet
Roquette Dextrose Anhydrous Biopharma Technical Data Sheet
Roquette Dextrose Anhydrous Biopharma Technical Data Sheet
Technical Data SheetSafety Data Sheet
Roquette Dextrose Anhydrous Biopharma Safety Data Sheet (US - EN)
Roquette Dextrose Anhydrous Biopharma Safety Data Sheet (US - EN)
Safety Data SheetSafety Data Sheet
Roquette Dextrose Anhydrous Biopharma Safety Data Sheet (REC - ES)
Roquette Dextrose Anhydrous Biopharma Safety Data Sheet (REC - ES)
Safety Data SheetSafety Data Sheet
Roquette Dextrose Anhydrous Biopharma Safety Data Sheet (REC - PT)
Roquette Dextrose Anhydrous Biopharma Safety Data Sheet (REC - PT)
Safety Data SheetSafety Data Sheet
Roquette Dextrose Anhydrous Biopharma Safety Data Sheet (REC - EN)
Roquette Dextrose Anhydrous Biopharma Safety Data Sheet (REC - EN)
Safety Data SheetKnowde Enhanced TDS
Identification & Functionality
Chemical Name
Pharma & Nutraceuticals Functions
CAS No.
EC No.
Technologies
Applications & Uses
Properties
Typical Properties
| Value | Units | Test Method / Conditions | |
| Arsenic Content | max. 1 | ppm | FCC |
| Assay - Reducing Sugars | 99.5 - 100.5 | % | FCC |
| Assay (Dextrose) | 97.5 - 102.0 | % | EP / USP / JP |
| Chloride Content | max. 0.018 | % | FCC |
| Heavy Metals | max. 4 | ppm | JP |
| Lead Content | max. 0.1 | ppm | FCC |
| Loss on Drying | max. 2.0 | % | FCC |
| Optical Specific Rotation | max. 2.0 | % | FCC |
| Residue on Ignition | max. 0.1 | % | FCC |
| Soluble Starch, Sulfites | max. 15 | ppm | EP / USP / JP |
| Sulfur Dioxide | max. 0.002 | % | FCC |
| Total Impurities | max. 0.5 | % | EP / USP / JP |
| Unspecified Impurities | max. 0.10 | % | EP / USP / JP |
| Water Content | max. 1.0 | % | EP / USP / JP |
Microbiological Values
| Value | Units | Test Method / Conditions | |
| Escherichia coli | Not Detected | per gram | - |
| Pseudomonas aeruginosa | Not detected | per 10g | - |
| Salmonella | Not Detected | per 10g | - |
| Total Aerobic Microbial Count | max. 100 | CFU/g | - |
| Total Yeasts and Moulds Count | max. 100 | CFU/g | - |
Regulatory & Compliance
Grade
Quality Standards
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
- ROQ Product Code: 361417
- Article (SKU) Code: 361417102
- Package Size & Type: 12 kg lined PE drum
Storage & Handling
Shelf Life
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.
Roquette Dextrose Anhydrous Biopharma
Roquette