product
Producer:
Roquette Dextrose Anhydrous BioPharma from Roquette is used upstream in the cell culture process as an energy and carbon source during the production of therapeutic proteins. 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. Dextrose Anhydrous BioPharma is a multi-compendial material - USP, EP, JP. We are ready to help you with your upstream application needs for cell culture ingredients.
Roquette DEXTROSE ANHYDROUS BIOPHARMA
Producer:
Roquette Dextrose Anhydrous BioPharma from Roquette is used upstream in the cell culture process as an energy and carbon source during the production of therapeutic proteins. 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. Dextrose Anhydrous BioPharma is a multi-compendial material - USP, EP, JP. We are ready to help you with your upstream application needs for cell culture ingredients.
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Experts (1)
Knowde Enhanced TDS
Identification & Functionality
Compendial Name
Pharma & Nutraceuticals Functions
Technologies
Features & Benefits
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 in 1g | ||
| Pseudomonas Aeruginosa | Not detected in 10g | ||
| Salmonella Species | Not detected in 10g | ||
| Total Aerobic Microbial Count | max. 100 | CFU/g | |
| Total Yeasts and Moulds Count | max. 100 | CFU/g |
Color
White
Physical Form
Powder
Appearance
White or almost white, crystalline powder
Regulatory & Compliance
Quality Standards
Regulatory Status
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
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.
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