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CERELOSE® Coarse Dextrose NF - 020350

1 of 11 products in this brand
CERELOSE® Coarse Dextrose NF - 020350 is a coarse monohydrate dextrose product designed for applications requiring a unique coarser particle size profile, rounded and porous particle shape. This free-flowing material is manufactured according to IPEC cGMPs and tested for compliance with Dextrose Excipient NF standards. It can be used as an effective bulking agent in tablets, capsules, and other solid dosage forms to increase their volume and improve their handling properties besides having good compression ability. It meets the requirements of USP/ NF.

Ingredient Name: Dextrose Monohydrate

Labeling Claims: Halal, Kosher, Non-GMO, Not Listed In California Proposition 65

Functions: Binder, Bulking Agent, Carrier, Nutritive Sweetener, Sweetener, Taste Masker

Calories (Energy): 365.0 - 365.0 Cal/100 g

Certifications & Compliance: FDA Compliant, FSSC 22000, GFSI Certified, Generally Recognized As Safe (GRAS), Halal, ISO 22000, Kosher, National Formulary (NF), Non-GMO Project Verified, cGMP

Physical Form: Crystals, Powder, Solid

Synonyms: D(+)-Glucose, D-Glucose, Glucose

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Identification & Functionality

Ingredient Name
Food Ingredients Functions
CAS No.
77938-63-7
Ingredients
Dextrose Monohydrate
EC No.
616-580-9

Features & Benefits

Food Ingredients Features
Features and Benefits
  • Meets Dextrose Excipient NF requirements
  • Unique coarse particle size
  • Rounded, porous particle shape
  • No added binders
  • Free flowing
  • Very compressible
  • Good for tableting
  • Effective bulking
  • Carrier for flavors, colors, spices
  • Low dusting

Applications & Uses

Dosage Form
Manufacturing Technology
Food & Nutrition Applications

Properties

Odor
No detectable foreign odor
Flavor
Clean sweet taste
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Water (Identification C)7.5 - 9.5
Dextrose Equivalent97.5 - 102% db
Identification APassesU.S.P. Test
Identification BPassesU.S.P. Test
Maltose and Isomaltose0.6%
Maltotriose0.2%
Fructose0.15%
Unspecified Related Substances0.1%
Total Impurities0.7%
Elemental ImpuritiesPassesU.S.P. Test
AcidityPassesU.S.P. Test
Arsenic Content1ppm
Residue on Ignition0.1%
Chlorides180ppm
Color of SolutionPassesU.S.P. Test
DextrinPassesU.S.P. Test
Soluble Starch (Sulfites)PassesU.S.P. Test
SulfatesPassesU.S.P. Test
Microbiological Values
ValueUnitsTest Method / Conditions
Standard Plate Countmax. 200cfu/g
Yeast and Molds Countmax. 20cfu/g
Coliformsmax. 10cfu/g
Escherichia coliNegativein 10g
SalmonellaNegativein 25g
Nutritional Information
ValueUnitsTest Method / Conditions
Calories365kcal/100g
Total Fat *max. 0.1g/100g
Cholesterol0mg/100g
Sodium *max. 2mg/100g
Total Carbohydrates91.3g/100g
Dietary Fiber0g/100g
Total Sugars *91.2g/100g
Added Sugars0g/100g
Other Carbohydrates0.1g/100g
Protein *max. 0.1g/100g
Vitamin D0mcg/100g
Calcium *max. 2mg/100g
Iron *max. 0.2mg/100g
Potassium *max. 1mg/100g
Total Ash Content *max. 0.1g/100g
Screen Test
ValueUnitsTest Method / Conditions
U.S.S. #16 Mesh (1.19 mm)max. 1%
U.S.S. #30 Mesh (595 micron)max. 12%
Through U.S.S. #100 Mesh (149 microns)25%
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 NF (National Formulary) requirements
    • Standard of Identity : 21 CFR 168.111
    • GRAS Affirmation : 21 CFR 184.1857
    • Labeling : Dextrose or Dextrose monohydrate
  • Canada
    • Standard Food : CFDA Regulation
    • Standard of Identity : B.18.015
    • Labeling : Dextrose or Dextrose monohydrate

Packaging & Availability

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

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.