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CERELOSE® Anhydrous Dextrose - USP Grade - 025020

1 of 11 products in this brand
CERELOSE® Anhydrous Dextrose - USP Grade - 025020 is a white crystalline powder with Exceptional purity made particularly for the pharmaceutical industry. This high-quality dextrose is made under cGMP and used as an active ingredient for parenteral applications. The product will contain less than 1.25 units of endotoxin per gram by LAL test. Therefore, it meets the requirements of the United States Pharmacopeia, USP.

Chemical Name: Dextrose Monohydrate

CAS Number: 77938-63-7

Certifications & Compliance: FDA Compliant, FSSC 22000, GFSI Certified, Generally Recognized As Safe (GRAS), Halal, ISO 22000, Kosher, Non-GMO Project Verified, United States Pharmacopeia (USP), cGMP

Dosage Form: Injectables

Labeling Claims: Halal, Kosher, Non-GMO

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Identification & Functionality

CAS No.
50-99-7
EC No.
200-075-1

Features & Benefits

Labeling Claims
Features and Benefits
  • White Crystalline Powder
  • Manufactured under cGMP
  • Exceptional purity
  • Free flowing
  • Certified to meet U.S.P. specifications
  • < 1.25 units of endotoxin per gram (by LAL test)

Applications & Uses

Dosage Form

Properties

Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Water (Identification C)max. 1.0--
Dextrose Equivalent97.5 - 102% db-
Identification APasses-U.S.P. Test
Identification BPasses-U.S.P. Test
Maltose and Isomaltose0.4%-
Maltotriose0.2%-
Fructose0.15%-
Unspecified Related Substances0.1%-
Total Impurities0.5%-
Conductivity20µS/cm-
Endotoxin (EU)0.06--
Non-Soluble Residue1A - 2C--
Microbiological Values
ValueUnitsTest Method / Conditions
Standard Plate Countmax. 200cfu/g-
Yeast and Molds Countmax. 20cfu/g-
Coliformsmax. 10cfu/g-
Escherichia coliNegativein 10g-
SalmonellaNegativein 10g-
Nutritional Information
ValueUnitsTest Method / Conditions
Calories399kcal/100g-
Total Fat *max. 0.1g/100g-
Cholesterol0mg/100g-
Sodium *max. 2mg/100g-
Total Carbohydrates99.9g/100g-
Dietary Fiber0g/100g-
Total Sugars *99.8g/100g-
Added Sugars0g/100g-
Other Carbohydrates0.1g/100g-
Proteinmax. 0.1g/100g-
Vitamin D0mcg/100g-
Calcium *max. 2mg/100g-
Iron *max. 0.2mg/100g-
Potassium *max. 10mg/100g-
Total Ash Content *max. 0.1g/100g-
Screen Test
ValueUnitsTest Method / Conditions
U.S.S. #20 Mesh (841 micron)max. 1%-
Note
  • * Not present at level of quantification.
  • ** “Total Sugars” in this product may contribute to “Added Sugars” for nutrition labeling purposes in the final consumer product.

Regulatory & Compliance

Regulatory Data
  • CAS Number : 50-99-7
  • United States
    • Meets U.S.P. requirements
    • Standard of Identity : 21 CFR 168.110
    • GRAS Affirmation : 21 CFR 184.1857
    • Labeling : Dextrose or Dextrose anhydrous or Anhydrous dextrose
  • Canada
    • Standard Food : CFDA Regulation
    • Standard of Identity : B.18.015
    • Labeling : Dextrose or Dextrose anhydrous or Anhydrous dextrose

Packaging & Availability

Packaging Type
Regional Availability
  • Global
Packaging Information
  • Bags
  • Totes
  • Drums
  • Bulk

Storage & Handling

Shelf Life
3 Years
Storage Conditions

Product should be stored in a clean, dry area, not exposed to high (> 90°F / 32°C), prolonged temperature.