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| Test Item | Analysis Specification | Result |
| Description | White to off white 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 | |
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