TESTING ITEMS | SPECIFICATIONS | RESULTS |
Appearance | White or almost white imperceptibility crystalline powder | Conforms |
Identification | Meet the requirement | Conforms |
Melting point | 198℃~207℃ | 205℃ |
Specific rotation | -41°~-45° | -43° |
Limit of Mercator | ≤0.10ml | 0.02ml |
Loss on drying | ≤0.50% | 0.18% |
Total impurities | ≤2.00% | 0.23% |
Methanol | ≤0.30% | Not detected |
Assay | 97.0%~103.0% | 99.80% |
Conclusion: The Product Conforms to CP/USP/EP. |