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Ethisterone炔孕酮434-03-7東康源純粉現(xiàn)貨質(zhì)量怎么樣？
分析證明
Certificate of Analysis
| 品名 | 炔孕酮 | 數(shù)量 | Sample |
| Product Name | Ethisterone | Batch Size | |
| 生產(chǎn)日期 | 批號 | ||
| Manufacturing Date | 2020.12.11 | Batch No. | 20201211 |
| 有效期 | 報告日期 | ||
| Expiry Date | 2023.12.10 | Report Date | 2020.12.18 |
| 檢驗依據(jù) | 中國藥典2015版 | 包裝 | |
| Reference Standard | CP2015 | Packing | |
| 檢驗項目 | 質(zhì)量標(biāo)準(zhǔn) | 檢驗結(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 | 合格 | |
| Characteristics | White or almost white crystalline powder | Conform | |
| 比旋度 | |||
| Specific rotation | ﹢28°~﹢33° | +30° | |
| 干燥失重 | |||
| Loss on drying | ≤0.5% | 0.19% | |
| 含量 | |||
| Assay | 97.0~ 103.0% | 98.21% | |
| 有關(guān)物質(zhì) | 合格 | ||
| Related substances | ≤0.5% | Pass | |
| 結(jié)論 | 本批號符合中國藥典2015版 | ||
| Conclusion | This batch complies with CP2015 |
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