| 品名 | 苯甲孕酮 |
| Product Name | ALGESTONE ACETOPHENIDE |
| 生产日期 | |
| Manufacturing Date | 2017.03.23 |
| 有效日期 | |
| Expiry Date | 2021.03.22 |
| 检验依据 | 企业标准 |
| Reference Standard | Enterprise standard |
| 检验项目 | 标准规定 |
| TEST | ACCEPTANCE CRITERIONS |
| 鉴别 | UV spectrum |
| Identification | IR spectrum |
| 性状 | 白色或乳白色结晶性粉末 |
| Characteristics | White or almost white crystalline powder |
| 溶液颜色 | 浅黄色 |
| Colour of solution | Light yellow |
| 熔点 | |
| Melting point | About 150℃ |
| 溶解性 | Insoluble in water, Soluble in Chloroform, |
| Solubitily | Acetone and Alcohol |
| 干燥失重 | |
| Loss on drying | ≤0.5% |
| 含量 | |
| Assay | 98.0% -- 102.0% |
| 硫酸盐灰分 | |
| Sulphate ash | It should be not more than 0.1% |
| 比旋度 | |
| Specific optical rotation | ﹢45°~﹢55° (1% Chloroform） |
| 残留溶剂 | Toluene ≤890ppm |
| Residue solvents | Isopropanol ≤5000ppm |
| Heptane ≤5000ppm | |
| 有关物质 | Total Impurities : MAX 1.0% |
| Related substance | Dihydroprogesterone Acetonide less than 0.15% |
| Any other impurity not Identified less than 0.1% | |
| 结论 | 本批号符合企业标准 |
| Conclusion | This batch complies with Enterprise standard |
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