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Roquette DEXTROSE ANHYDROUS BIOPHARMA
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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

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Identification & Functionality

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Properties

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Physical Form
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 detected in 1g
Pseudomonas AeruginosaNot detected in 10g
Salmonella SpeciesNot detected in 10g
Total Aerobic Microbial Countmax. 100CFU/g
Total Yeasts and Moulds Countmax. 100CFU/g
Color
White
Physical Form
Powder
Appearance
White or almost white, crystalline powder

Storage & Handling

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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.

Documents (5)

Name
Type
Roquette DEXTROSE ANHYDROUS BIOPHARMA Safety Data Sheet (US - EN)
Safety Data Sheet
Roquette DEXTROSE ANHYDROUS BIOPHARMA Safety Data Sheet (REC - PT)
Safety Data Sheet
Roquette DEXTROSE ANHYDROUS BIOPHARMA Safety Data Sheet (REC - ES)
Safety Data Sheet
Roquette DEXTROSE ANHYDROUS BIOPHARMA Safety Data Sheet (REC - EN)
Safety Data Sheet
Roquette DEXTROSE ANHYDROUS BIOPHARMA Technical Data Sheet
Technical Data Sheet