TESTING ITEMS | SPECIFICATIONS | RESULTS |
Appearance | White crystalline powder | Conforms |
Identification | Meet the requirement | Conforms |
Melting point | 195℃~201℃ | 197℃ |
Specific rotation | -0.10°~+0.10° | +0.02° |
Loss on drying | ≤0.50% | 0.11% |
Residue on ignition | ≤0.20% | 0.07% |
Heavy metals | ≤0.002% | 0.001% |
Assay | 98.0%~102.0% | 99.50% |
Conclusion: The Product Conforms to USP/EP. |