| 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% | |
Sulted 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% | |
Microbiological Analysis | |||
Total plate count | ≤1000cfu/g | Complies | |
Yeast and Moulds | ≤100cfu/g | Complies | |
E. Coli. | Absent | Negative | |
Salmonella | Absent | Negative | |
S.aureus | Absent | Negative | |
Storage | Preserve in well-closed, light-resistant and airtight containers. | Complies | |
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