| ITEM | STANDARD | RESULTS |
| Appearance | 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% | 99.92% |
| Conclusion | Accordance with the reference |
