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 | âⰤ0.5% | 0.11% | |
Heavy metals | âⰤ10 ppm | <10ppm | |
Sulphated ash | âⰤ0.2%, determined on 1.0 g. | 0.009% | |
Related substances | Unspecified impurities: for each impurity | âⰤ0.10% | <0.10% |
Total Impurity | âⰤ1.0% | 0.18% | |
Purity | âⰥ99.0% | 99.82% | |
Assay | 99.0%~101.0% (anhydrous substance). | 99.9% |
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