Test Item | Analysis Specification | Result |
Description | crystalline powder | Conforms |
Melting range | 129°C~132°C | 130.8°C-131°C |
Loss on drying | ≤0.5% | 0.20 % |
Specific rotation | -58°~-62°(C=1,in CH3OH) | -61.05° |
Sulphated ash | ≤0.1% | 0.08 % |
Heavy metals | ≤10ppm | Conforms |
Chlorides | ≤0.02% | Conforms |
Sulfates | ≤0.02% | Conforms |
Fluorine | 14.7%~17.9% | 15.2% |
Residual solvent | Methanol ≤0.2% Isopropanol ≤0.2% Ethyl acetate≤0.2% Chloroform ≤0.2% | 0.0% 0.0% 0.0% 0.0% |
Related substances (HPLC) | Single impurity ≤0.2% Total impurities ≤0.5% | 0.05% 0.08% |
Assay | ≥99.5% | 99.9% |
Conclusion | Accordance with the reference |