CERELOSE® Coarse Dextrose NF - 020350
- CAS Number
- 77938-63-7
- EC Number
- 616-580-9
- Chemical Name
- Dextrose Monohydrate, Glucose
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.
Properties
- Physical Form
- Crystals, Powder, Solid
- Crystals
- Powder
- Solid
Other characteristics
- Brand
- CERELOSE
- Synonyms
- D(+)-Glucose, D-Glucose, Glucose
- Functions
Binder, Bulking Agent, Carrier, Nutritive Sweetener, Sweetener, Taste Masker
- Ingredient Name
- Dextrose Monohydrate
- Labeling Claims
Halal, Kosher, Non-GMO, Not Listed In California Proposition 65; Halal; Kosher; Non-GMO; Not Listed In California Proposition 65
- Calories (Energy)
- 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
- 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.
- Odor
- No detectable foreign odor
- Grade
- Pharma Grade
- Flavor
- Clean sweet taste
- Markets
- Food & Nutrition
- Healthcare & Pharma
- Shelf LIfe
- 3 Years
- Dosage Form
- Capsules
- Tablets
- Ingredient
- Dextrose Monohydrate
- Technology
- Food Ingredients
- Pharmaceuticals & Nutraceuticals
- Packaging Type
- Bags
- Totes (IBC)
- Storage Condition
Product should be stored in a clean, dry area, not exposed to high (> 90°F / 32°C), prolonged temperature.
Technical data
Table 1 of 4
18 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Water (Identification C) | 7.5 - 9.5 | — | — |
| Dextrose Equivalent | 97.5 - 102 | % db | — |
| Identification A | Passes | — | U.S.P. Test |
| Identification B | Passes | — | U.S.P. Test |
| Maltose and Isomaltose | 0.6 | % | — |
| Maltotriose | 0.2 | % | — |
| Fructose | 0.15 | % | — |
| Unspecified Related Substances | 0.1 | % | — |
| Total Impurities | 0.7 | % | — |
| Elemental Impurities | Passes | — | U.S.P. Test |
| Acidity | Passes | — | U.S.P. Test |
| Arsenic Content | 1 | ppm | — |
Table 2 of 4
5 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Standard Plate Count | max. 200 | cfu/g | — |
| Yeast and Molds Count | max. 20 | cfu/g | — |
| Coliforms | max. 10 | cfu/g | MTH000063--Total Coliform w/E.Coli Enumeration-Petrifilm Test |
| Escherichia coli | Negative | in 10g | — |
| Salmonella | Negative | in 25g | — |
Table 3 of 4
15 rows| Characteristic | Value | Unit |
|---|---|---|
| Calories | 365 | kcal/100g |
| Total Fat * | max. 0.1 | g/100g |
| Cholesterol | 0 | mg/100g |
| Sodium * | max. 2 | mg/100g |
| Total Carbohydrates | 91.3 | g/100g |
| Dietary Fiber | 0 | g/100g |
| Total Sugars * | 91.2 | g/100g |
| Added Sugars | 0 | g/100g |
| Other Carbohydrates | 0.1 | g/100g |
| Protein * | max. 0.1 | g/100g |
| Vitamin D | 0 | mcg/100g |
| Calcium * | max. 2 | mg/100g |
Table 4 of 4
3 rows| Characteristic | Value | Unit |
|---|---|---|
| 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 | % |
