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環(huán)戊丙酸雌二醇,313-06-4,質(zhì)檢單
分析證明
Certificate of Analysis
| 品名 | 環(huán)戊丙酸雌二醇 | 數(shù)量 | |
| Product Name | Estradiol cypionate | Batch Size | 20KG |
| 生產(chǎn)日期 | 批號 | ||
| Manufacturing Date | 2021.02.13 | Batch No. | 20210213 |
| 有效期 | 報(bào)告日期 | ||
| Expiry Date | 2024.02.12 | Report Date | 2021.02.21 |
| 檢驗(yàn)依據(jù) | 美國 藥典 32 版 | 包裝 | 紙板桶 |
| Reference Standard | USP 32 | Packing | |
| 檢驗(yàn)項(xiàng)目 | 質(zhì)量標(biāo)準(zhǔn) | 檢驗(yàn)結(jié)果 | |
| TEST | ACCEPTANCE CRITERIONS | RESULTS | |
| 正性反應(yīng) | |||
| 鑒別 | TLC | Positive | |
| Identification | UV spectrum | Positive | |
| IR spectrum | Positive | ||
| 性狀 | 白色或類白色結(jié)晶性粉末 | 符合規(guī)定 | |
| Appearance | White or Practically white crystalline powder | Confirm | |
| 熔點(diǎn) | |||
| 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% | |
| 熾灼殘?jiān)?/td> | |||
| Residue on ignition | ≤0.2% | 0.08% | |
| 有機(jī)酸 | |||
| Free acid | ≤0.5% | 0.29% | |
| 含量 | |||
| Assay | 97.0 ~ 103.0％ | 98.68% | |
| Related substances | ≤2％ | Pass | |
| 結(jié)論 | 本批號符合 美國 藥典 32 版 | ||
| Conclusion | This batch complies with USP 32 |
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