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苯甲酸雌二醇丨50-50-0丨质量信息COA
| 分析证明 | |||
| Certificate of Analysis | |||
| 品名 | 苯甲酸雌二醇 | 数量 | Sample |
| Product Name | Estradiol Benzoate | Batch Size | 样品 |
| 生产日期 | 批号 | ||
| Manufacturing Date | 2023.03.06 | Batch No. | 20230306 |
| 有效期 | 报告日期 | ||
| Expiry Date | 2025.03.05 | Report Date | 2023.03.06 |
| 检验依据 | 美国药典 40 版 | 包装 | |
| Reference Standard | USP 40 | Packing | |
| 检验项目 | 质量标准 | 检验结果 | |
| TEST | ACCEPTANCE CRITERIONS | RESULTS | |
| 鉴别 | 正性反应 | ||
| Identification | TLC | Positive | |
| IR spectrum | Positive | ||
| 性状 | 白色或类白色结晶性粉末 | 符合规定 | |
| Characteristics | almost white, crystalline powdeor colourless crystals | conform | |
| 溶解性 | practically insoluble in water ,freely soluble in methylene | 符合规定 | |
| Solubility | chloride sparingly soluble in acetone,slightly soluble in methanol | conform | |
| 灼烧残渣 | |||
| Residue on ignition | ≤0.2% | 0.10% | |
| 比旋度 | |||
| Specific rotation | ﹢57.0 °~﹢63.0° | ﹢57.5° | |
| 干燥失重 | |||
| Loss on drying | ≤0.5% | 0.14% | |
| 有关物质 | Any individual impurity ≤ 1.0% | 0.25% | |
| Related substances | Total impurities ≤ 2.0% | 0.78% | |
| 含量 | |||
| Assay | 97.0 ~ 103.0% | 99.10% | |
| 有机溶剂限量 | 合格 | ||
| Limit of methanol and | ≤0.20% | Pass | |
| dichloromethane | |||
| 结论 | 本批号符合美国药典 40 版 | ||
| Conclusion | This batch complies with USP40 | ||
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