| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Non-Customized |
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| Items | Specification | Results | |||
| Color and Clarity of Solution | The sample solution is clear and not more intensely colored than the reference solution |
Passes Test | |||
| Identification | A. Meets the requirement | Passes Test | |||
| B. Meets the requirement | Passes Test | ||||
| C. Water≤1.0% | 0.08% | ||||
| Assay | 97.5%-102.0% | 99.7% | |||
| Related Substances | Maltose and Isomaltose≤0.4% | 0.08% | |||
| Maltotriose≤0.2% | 0.01% | ||||
| Fructose≤0.15% | 0% | ||||
| Unspecified≤0.10% | 0.01% | ||||
| Total Impurities≤0.5% | 0.1% | ||||
| Conductivity | ≤20 μS/cm | 2.1 μS/cm | |||
| Dextrin | The sample dissolves completely | Passes Test | |||
| Soluble Starch, Sulfites | ≤15ppm | <15ppm | |||
| Aerobic Plate Count | ≤1000cfu/g | 10cfu/g | |||
| Moulds and Yeasts | ≤100cfu/g | <10cfu/g | |||
| Escherichia Coli | Negative | Negative | |||
| Bacterial Endotoxin | ≤1.25EU/g | <0.03EU/g | |||
| Conclusion : | The products meet the requirements of USP43. | ||||
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