TESTING ITEMS | SPECIFICATIONS | RESULTS |
Appearance | White, crystalline powder or white or almost white crystals, slightly hydroscopic | Conforms |
Appearance of solution | B5 | Conforms |
Identification | Positive | Positive |
Melting point | 120℃~124℃ | 123℃ |
PH | 6.5~8.5 | 7.6 |
Loss on drying | 16.0%~17.5% | 16.5% |
Heavy metals | ≤10ppm | 2ppm |
Related substances | Impurity A: ≤0.1% | 0.02% |
Any other impurity: ≤0.1% | 0.07% | |
Total impurities: ≤1.0% | 0.09% | |
Assay | 99.0%~101.0% | 99.50% |
Conclusion: The Product Conforms to USP/EP. |