item | standard | test results | |
identification |
a.h-nmr:comply with the structure |
complies |
|
b.lc-ms:comply with the structure |
complies |
||
c.the ir spectrum of sample should be identical with that of reference standard; |
complies |
||
d.hplc-esi-ms the retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the assay. |
complies |
||
loss on drying |
≤0.5% |
0.11% |
|
heavy metals |
≤10 ppm |
<10ppm |
|
sulphated ash |
≤0.2%, determined on 1.0 g. |
0.009% |
|
related substances |
unspecified impurities: for each impurity |
≤0.10% |
<0.10% |
total impurity |
≤1.0% |
0.18% |
|
purity |
≥99.0% |
99.82% |
|
assay |
99.0%~101.0% (anhydrous substance). |
99.9% |