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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 |
||
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 Impurities | ≤0.5% | 0.18% | |
Purity | ≥99.0% | 99.7% | |
Assay | 99.0%~101.0% (anhydrous substance). | 99.8% |
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