TESTING ITEMS | SPECIFICATIONS | RESULTS |
Characteristics | White or almost white crystalline powder | Conforms |
Identification | Meet the requirements | Conforms |
Specific rotation | -17.0°~-15.3° | -16.7° |
Loss on drying | ≤1.0% | 0.18% |
Residue on ignition | ≤0.1% | 0.06% |
Heavy metals | ≤20ppm | <20ppm |
Related substance | Any other impurity ≤0.1% | 0.01% |
Total impurities ≤0.5% | 0.01% | |
Assay | 98.5%~101.5% | 99.91% |
Conclusion: The Product Conforms to CP/USP/EP. |