Roquette Dextrose Anhydrous C - Pharma

Dextrose Anhydrous is a sugar carbohydrate used for as a filler and a carbohydrate source in pharma oral dosage and nutraceutical forms, including swallowable tablets, chewable tablets, effervescent tablets and medicated confectionaries. Features Monomer of natural starch polymer that is also the natural physiological sugar in the human body Provides key excipient and nutrient benefits Natural low water content compared to dextrose monohydrate t High stability Available as a range of products to meet application requirements of manufacturers

Functions: Binder, Filler

Certifications & Compliance: EXCiPACT, European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), United States Pharmacopeia (USP)

Labeling Claims: Low Water Content, Natural

Dosage Form: Tablets

Knowde Enhanced TDS

Identification & Functionality

Chemical Family
Pharma & Nutraceuticals Functions

Features & Benefits

Applications & Uses

Dosage Form
Food & Nutrition Applications


Physical Form
White or almost white crystalline powder
Soluble in
Water, Ethanol (96%)
Typical Properties
ValueUnitsTest Method / Conditions
Average Particle Size (Laser)300microns
Bulk Densityapprox. 0.85kg/l
Conductivitymax. 20microS/cmEP / USP-NF
DextrinCompliesEP / USP-NF
Identification Test ACompliesEP
Identification Test A (*)CompliesUSP-NF
Identification Test BCompliesEP / USP-NF
Identification Test CCompliesUSP-NF
Identification Test ECompliesEP
Impurity C, Maltotriosemax. 0.2%EP / USP-NF
Impurity D: Fructosemax. 0.15%EP / USP-NF
Particle Size (min. 1000 microns)max. 5%
Particle Size (min. 250 microns)max. 70%
Particle Size (min. 40 microns)min. 90%
Soluble Starch Sulfitesmax. 15ppmEP / USP-NF
Sum of Impurities A and B, Maltose and Isomaltosemax. 0.4%EP / USP-NF
Total Impuritiesmax. 0.5%
Unspecified Impuritiesmax. 0.10%EP / USP-NF
Water Contentmax. 1.0%EP / USP-NF
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Assay Content97.5 - 102.0%EP / USP-NF
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coli (**)Not detectedper gram
Total Aerobic Microbial Count (**)max. 1000CFU/g
Total Yeasts and Moulds Count (**)max. 100CFU/g
Salmonella (**)Not detectedper 10g
  • (*) - Compliance data - Tests not performed
  • (**) - Monitoring plan

Regulatory & Compliance

Conforms to the requirements of the current monograph
  • European Pharmacopeia (EP)
  • US Pharmacopeia (USP)
  • Please contact us for any statement regarding compliance to the General Chapters (elemental impurities, residual solvents, organic volatile impurities, metal catalyst, metal reagent).

Technical Details & Test Data

Test Data

Methods used by Roquette may be the Pharmacopeia methods or alternative validated methods which have been compared to the Pharmacopeia methods.

Packaging & Availability

Packaging Information
  • ROQ Product Code: 361413
  • Article (SKU) Code: 361413331G
  • Package Size & Type: 25 kg paper bag

Storage & Handling

Storage & Shelf Life
  • Expiry date Manufacturing date + 5 years, in its unopened packaging.
  • We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations in temperature and humidity.