| 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% |
| 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 |
Complaint
