新闻中心
环戊丙酸雌二醇,313-06-4,质检单
分析证明
Certificate of Analysis
| 品名 | 环戊丙酸雌二醇 | 数量 | |
| Product Name | Estradiol cypionate | Batch Size | 20KG |
| 生产日期 | 批号 | ||
| Manufacturing Date | 2021.02.13 | Batch No. | 20210213 |
| 有效期 | 报告日期 | ||
| Expiry Date | 2024.02.12 | Report Date | 2021.02.21 |
| 检验依据 | 美国 药典 32 版 | 包装 | 纸板桶 |
| Reference Standard | USP 32 | Packing | |
| 检验项目 | 质量标准 | 检验结果 | |
| TEST | ACCEPTANCE CRITERIONS | RESULTS | |
| 正性反应 | |||
| 鉴别 | TLC | Positive | |
| Identification | UV spectrum | Positive | |
| IR spectrum | Positive | ||
| 性状 | 白色或类白色结晶性粉末 | 符合规定 | |
| Appearance | White or Practically white crystalline powder | Confirm | |
| 熔点 | |||
| Melting point | 149 ~ 153℃ | 150~ 153℃ | |
| 比旋度 | |||
| Specific roation | ﹢39°~﹢44° |
﹢41.5° | |
| 干燥失重 | |||
| Loss on drying | ≤1.0% | 0.21% | |
| 炽灼残渣 | |||
| Residue on ignition | ≤0.2% | 0.08% | |
| 有机酸 | |||
| Free acid | ≤0.5% | 0.29% | |
| 含量 | |||
| Assay | 97.0 ~ 103.0％ | 98.68% | |
| Related substances | ≤2％ | Pass | |
| 结论 | 本批号符合 美国 药典 32 版 | ||
| Conclusion | This batch complies with USP 32 |
< 返回 >
