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
≤2.0%
0.19%
Heavy metals
≤10 ppm
<10ppm
Water
≤1.0%
0.1%
Sulphated ash
≤0.5% determined on 1.0 g.
0.009%
Residue on ignition
≤0.1%
0.03%
Related Substances
Unspecified impurities: for each impurity ≤0.10%
<0.10%
Total Impurity ≤0.5%
0.18%
Purity
≥99.0%
99.7%
Assay
99.0%~101.0% (anhydrous substance).
99.8%
Storage
Preserve in well-closed, light-resistant and airtight containers.
Complies
