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 |
Crystallinity | meets the requirements. | 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% |
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 |
China
