| | |
Identification
| A.H-NMR:Comply with the structure | |
B.LC-MS:Comply with the structure | |
C.The IR spectrum of sample should be identical with that of reference standard. | |
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. | |
Loss on drying | ≤2.0% | |
Heavy metals | ≤10 ppm | |
Water | ≤1.0% | |
Sulphated ash | ≤0.5% determined on 1.0 g. | |
Residue on ignition | ≤0.1% | |
| Unspecified impurities: for each impurity | ≤0.10% | |
Total Impurities | ≤0.5% | |
Purity | ≥99.0% | |
Assay | 99.0%~101.0% (anhydrous substance). | |
Storage | Preserve in well-closed, light-resistant and airtight containers. | |
China
