TESTING ITEMS | SPECIFICATION | RESULTS |
Appearance | White or almost white crystalline powder | Conforms |
Identification | Meet the requirement | Conforms |
Loss on drying | ≤2.5% | 1.25% |
Residue on ignition | ≤0.1% | 0.05% |
Sulphated ash | ≤0.1% | 0.06% |
Related substances | Any single impurity ≤0.1% | ND |
Total impurities ≤0.2% | 0.04% | |
Residual solvents | Ethanol ≤5000ppm | 58ppm |
Dichloromethane ≤600ppm | ND | |
Tert-butyl methyl ether ≤5000ppm | ND | |
Assay | 98.5%~ 101.5% | 99.92% |
Conclusion: The Product Conforms to CP/USP/EP. |