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% |
99.92% |
conclusion |
accordance with the reference |