TESTING ITEMS | SPECIFICATION | RESULTS |
Appearance | White crystalline powder | Conforms |
Melting point | 128℃~132℃ | 128.6℃~129.4℃ |
Loss on drying | ≤1.0% | 0.26% |
Specific optical rotation | -15.7°~-17.3° | -16.17° |
Residue on ignition | ≤0.1% | 0.04% |
Heavy metals | ≤20ppm | 10ppm |
Absence of reducing substance | The color of the solution does not change | Conforms |
Completeness and color of the solution | Absorbance ≤0.03% | 0.01% |
Assay(on the dried basis) | 99.0%~100.5% | 99.54% |
Conclusion: The Product Conforms to USP. |