Specifications:
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% 0.0%
Isopropanol ≤0.2% 0.0%
Ethyl acetate≤0.2% 0.0%
Chloroform ≤0.2% 0.0%
Related substances(HPLC):
Single impurity ≤0.2% 0.05%
Total impurities ≤0.5% 0.08%
Assay: ≥99.5% 99.36%
