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雌三醇50-27-1,质检单
分 析 证 明
Certificate of Analysis
| 品名 | 雌三醇 | 数量 | |
| Product Name | Estriol | Batch Size | 10KG |
| 生产日期 | 批号 | ||
| Manufacturing Date | 2020.11.19 | Batch No. | 20201119 |
| 有效期 | 报告日期 | ||
| Expiry Date | 2022.11.18 | Report Date | 2020.11.19 |
| 检验依据 | 美 国 药 典 35 版 | 包装 | |
| Reference Standard | USP 35 | Packing | |
| 检验项目 | 质量标准 | 检验结果 | |
| TEST | ACCEPTANCE CRITERIONS | RESULTS | |
| 鉴别 | A:IR | Positive | |
| Identification | B:UV | Positive | |
| 性状 | 白色或类白色结晶性粉末 | 符合规定 | |
| Characteristics | White or practically white， crystalline powder | conform | |
| 比旋度 | |||
| Specific rotation | ﹢54°~﹢62° | ﹢55.60° | |
| 含量 | |||
| Assay | 97 .0~ 102.0% | 98.90% | |
| 干燥失重 | |||
| Loss on drying | ≤0.5% | 0.13% | |
| 有关物质 | Pass | ||
| Related substances | total impurities ≤2.0% | Pass | |
| 灼烧残渣 | |||
| Residual on ignition | ≤0.10% | 0.08% | |
| 结论 | 本批号符合 美 国 药 典 35 版 | ||
| Conclusion | This batch complies with USP 35 | ||
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