TESTING ITEMS | SPECIFICATION | RESULTS |
Appearance | White or yellow-white crystalline powder | Conforms |
Identification | Meet the requirement | Conforms |
Melting point | 149℃~153℃ | 152℃ |
Specific rotation | +18.5°~+20.5° | +19.7° |
Acidity | ≤0.1ml | <0.1ml |
Loss on drying | ≤0.5% | 0.21% |
Residue on ignition | ≤0.1% | 0.05% |
Sulphated ash | ≤0.1% | 0.04% |
Related substances | ≤0.5% | 0.19% |
Assay | 98.0%~ 102.0% | 99.10% |
Conclusion: The Product Conforms to CP/USP/EP. |