TESTING ITEMS | SPECIFICATIONS | RESULTS |
Appearance | Light yellow or yellow crystals powder | Conforms |
Identification | Meet the requirement | Conforms |
Specific rotation | -2.5°~-3.5° | -3.25° |
Loss on drying | ≤0.5% | 0.12% |
Residue on ignition | ≤0.1% | 0.03% |
Heavy metals | ≤0.002% | 0.0001% |
Related substance | Single impurity ≤0.2% | 0.14% |
Total impurities ≤0.5% | 0.18% | |
Assay | 98.5%~102.0% | 99.60% |
Conclusion: The Product Conforms to CP/USP/EP. |