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炔雌醇,57-63-6,质检单
分析证明
Certificate of Analysis
| 品名 | 炔雌醇 | 数量 | 0.05kg |
| Product Name | Ethinyl Estradiol | Batch Size | 样品 |
| 生产日期 | 批号 | ||
| Manufacturing Date | 2023.07.05 | Batch No. | 20230705 |
| 有效期 | 报告日期 | ||
| Expiry Date | 2025.07.04 | Report Date | 2023.07.10 |
| 检验依据 | 美国 药典 38 版 | 包装 | |
| Reference Standard | USP38 | Packing | |
| 检验项目 | 标准 规定 | 检验结果 | |
| TEST | Specifications | RESULTS | |
| 正性反应 | |||
| 鉴别 | TLC | Positive | |
| Identification | UV spectrum | Positive | |
| UV spectrum | Positive | ||
| 性状 | 白色至乳白色无气味结晶性粉末 | 符合规定 | |
| Characteristics | White to creamy white, odorless,crystalline powder. | conform | |
| 溶解性 | |||
| Solubility | Soluble in alcohol, in chloroform, in ether, in vegetable oils, | 符合规定 | |
| and in solutions of fixed alkali hydroxides; insoluble in water. | conform | ||
| 溶液澄清度 | |||
| Completeness of solution | Dissolve 100 mg in 5 mL of alcohol; the solution is clear | 符合规定 | |
| and free from undissolved solid. | conform | ||
| 熔点 | |||
| Melting point | 180~ 186℃ | 181.6~ 183.2℃ | |
| 比旋度 | |||
| Specific optical rotation | - 28°~ -29.5° | -28.3° | |
| 干燥失重 | |||
| Loss on drying | ≤1.0% | 0.38% | |
| 含量 | |||
| Content | 97.0 ~ 102.0% | 99.32% | |
| 溶剂残留 | |||
| Residual Solvents | acetone≤5000ppm | 102ppm | |
| 结论 | 本批号符合美国 药典 38版 | ||
| Conclusion | This batch complies with USP38 | ||
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