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苯甲酸雌二醇丨50-50-0丨質(zhì)量信息COA
| 分析證明 | |||
| Certificate of Analysis | |||
| 品名 | 苯甲酸雌二醇 | 數(shù)量 | Sample |
| Product Name | Estradiol Benzoate | Batch Size | 樣品 |
| 生產(chǎn)日期 | 批號(hào) | ||
| Manufacturing Date | 2023.03.06 | Batch No. | 20230306 |
| 有效期 | 報(bào)告日期 | ||
| Expiry Date | 2025.03.05 | Report Date | 2023.03.06 |
| 檢驗(yàn)依據(jù) | 美國藥典 40 版 | 包裝 | |
| Reference Standard | USP 40 | Packing | |
| 檢驗(yàn)項(xiàng)目 | 質(zhì)量標(biāo)準(zhǔn) | 檢驗(yàn)結(jié)果 | |
| TEST | ACCEPTANCE CRITERIONS | RESULTS | |
| 鑒別 | 正性反應(yīng) | ||
| Identification | TLC | Positive | |
| IR spectrum | Positive | ||
| 性狀 | 白色或類白色結(jié)晶性粉末 | 符合規(guī)定 | |
| Characteristics | almost white, crystalline powdeor colourless crystals | conform | |
| 溶解性 | practically insoluble in water ,freely soluble in methylene | 符合規(guī)定 | |
| Solubility | chloride sparingly soluble in acetone,slightly soluble in methanol | conform | |
| 灼燒殘?jiān)?/td> | |||
| Residue on ignition | ≤0.2% | 0.10% | |
| 比旋度 | |||
| Specific rotation | ﹢57.0 °~﹢63.0° | ﹢57.5° | |
| 干燥失重 | |||
| Loss on drying | ≤0.5% | 0.14% | |
| 有關(guān)物質(zhì) | Any individual impurity ≤ 1.0% | 0.25% | |
| Related substances | Total impurities ≤ 2.0% | 0.78% | |
| 含量 | |||
| Assay | 97.0 ~ 103.0% | 99.10% | |
| 有機(jī)溶劑限量 | 合格 | ||
| Limit of methanol and | ≤0.20% | Pass | |
| dichloromethane | |||
| 結(jié)論 | 本批號(hào)符合美國藥典 40 版 | ||
| Conclusion | This batch complies with USP40 | ||
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