Storage conditions: -20°C Freezer
| Items of Analysis | Standard of Analysis | Test Results | ||
| Appearance | Off-white to pale yellow powder | Off-white powder | ||
| Specific rotation（°） | +13.0~+18.0 | +17.9 | ||
| Identification | IR | Consistent with the reference | Consistent with the reference | |
| Calcium salt | Positive response | Positive response | ||
| GC | The main peak retention time consistent with the reference | The main peak retention time consistent with the reference | ||
| Water (%，w/w) |
≤3.0 | 2.5 | ||
| Loss on drying (%，w/w) |
≤3.0 | 1.7 | ||
| Relative Substance (%，area，HPLC) |
Single impurity | ≤0.10 | <0.05 | |
| Total impurity | ≤1.0 | <0.05 | ||
| Diastereomer (EP Imp.B) |
≤0.15 | <0.05 | ||
| EP Imp.A | ≤0.10 | Not detected | ||
| 5-Keto acid (EP Imp.C) |
≤0.10 | <0.05 | ||
| Assay (%, ESTD, HPLC) |
98.0-102.0 | 99.7 | ||
| Conclusion | Conforms to Factory Standard | |||
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