CERELOSE® Anhydrous Dextrose - USP Grade - 025020
- CAS Number
- 77938-63-750-99-7
- EC Number
- 200-075-1
- Chemical Name
- Dextrose Monohydrate
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.
Properties
- Physical Form
- Crystals
- Powder
- Solid
Product families
Applications
- Parenteral
Product Families
- Active Pharmaceutical Ingredients (APIs)
Other characteristics
- Brand
- CERELOSE
- Dosage Form
- Injectables
- Labeling Claims
- Halal, Kosher, Non-GMO
- Halal
- Kosher
- Non-GMO
- 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
- 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.
- Grade
- Pharma Grade
- Markets
- Healthcare & Pharma
- Shelf LIfe
- 3 Years
- Technology
- Pharmaceuticals & Nutraceuticals
- Packaging Type
- Bags
- Bulk
- Drums
- Storage Condition
Product should be stored in a clean, dry area, not exposed to high (> 90°F / 32°C), prolonged temperature.
- Benefits and Features
- 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)
- Packaging Information
- Bags
- Totes
- Drums
- Bulk
- Certifications and Compliance
- FDA Compliant
- FSSC 22000
- GFSI Certified
- Generally Recognized As Safe (GRAS)
- Halal
- ISO 22000
- Kosher
- Non-GMO Project Verified
Technical data
Table 1 of 4
12 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Water (Identification C) | max. 1.0 | — | — |
| Dextrose Equivalent | 97.5 - 102 | % db | — |
| Identification A | Passes | — | U.S.P. Test |
| Identification B | Passes | — | U.S.P. Test |
| Maltose and Isomaltose | 0.4 | % | — |
| Maltotriose | 0.2 | % | — |
| Fructose | 0.15 | % | — |
| Unspecified Related Substances | 0.1 | % | — |
| Total Impurities | 0.5 | % | — |
| Conductivity | 20 | µS/cm | — |
| Endotoxin (EU) | 0.06 | — | — |
| Non-Soluble Residue | 1A - 2C | — | — |
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 10g | — |
Table 3 of 4
15 rows| Characteristic | Value | Unit |
|---|---|---|
| Calories | 399 | kcal/100g |
| Total Fat * | max. 0.1 | g/100g |
| Cholesterol | 0 | mg/100g |
| Sodium * | max. 2 | mg/100g |
| Total Carbohydrates | 99.9 | g/100g |
| Dietary Fiber | 0 | g/100g |
| Total Sugars * | 99.8 | 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
1 row| Characteristic | Value | Unit |
|---|---|---|
| U.S.S. #20 Mesh (841 micron) | max. 1 | % |
