Macron™ 4908-04 Dextrose, Anhydrous, Granular, USP Grade, 500g POLYSTORMOR Bottle
- 12 x 500g POLYSTORMOR Bottles/Case
- Manufacturer Part No: MK-4908-04
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Details
Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Identification C: Water (H₂O) | <= 1.0 % |
| USP - Assay (Anhydrous basis) | 97.5 - 102.0 % |
| USP - Related substances: Maltose and isomaltose | <= 0.4 % |
| USP - Related substances: Maltotriose | <= 0.2 % |
| USP - Related substances: Fructose | <= 0.15 % |
| USP - Related substances: Unspecified impurities, each | <= 0.10 % |
| USP - Related substances: Total Impurities | <= 0.5 % |
| USP - Color and Clarity of Solution | Passes Test |
| USP - Soluble Starch, Sulfites | <= 15 ppm |
| USP - Conductivity (uS cm-1) | <= 20 µS/cm |
| USP - Heavy Metals (as Pb) | <= 0.0005 % |
| USP - Dextrin | Passes Test |
| USP - Endotoxin Concentration (EU/g) | <= 2.5 |
| Solubility | Passes Test |
| Appearance (white, granular powder) | |
| Odorless | |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| Metallic Residues: No metal catalysts or metal reagents, as defined by | |
| EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | |
| this material. | |
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Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Identification C: Water (H₂O) | <= 1.0 % |
| USP - Assay (Anhydrous basis) | 97.5 - 102.0 % |
| USP - Related substances: Maltose and isomaltose | <= 0.4 % |
| USP - Related substances: Maltotriose | <= 0.2 % |
| USP - Related substances: Fructose | <= 0.15 % |
| USP - Related substances: Unspecified impurities, each | <= 0.10 % |
| USP - Related substances: Total Impurities | <= 0.5 % |
| USP - Color and Clarity of Solution | Passes Test |
| USP - Soluble Starch, Sulfites | <= 15 ppm |
| USP - Conductivity (uS cm-1) | <= 20 µS/cm |
| USP - Heavy Metals (as Pb) | <= 0.0005 % |
| USP - Dextrin | Passes Test |
| USP - Endotoxin Concentration (EU/g) | <= 2.5 |
| Solubility | Passes Test |
| Appearance (white, granular powder) | |
| Odorless | |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| Metallic Residues: No metal catalysts or metal reagents, as defined by | |
| EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | |
| this material. | |