|
Item |
Standard |
Test Results |
|
|
Identification |
A.H-NMR:Comply with the structure |
Complies |
|
|
B.LC-MS:Comply with the structure |
Complies |
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|
C.The IR spectrum of sample should be identical with that of reference standard; |
Complies |
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|
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% |
|