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分析證明
Certificate of Analysis
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品名Product Name |
雌二醇17a-Estradiol CAS:57-91-0 |
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生產日期 Manufacturing Date |
2023/05/17 |
批號 Batch No. |
202305002 |
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有效期 Expiry Date |
2026/05/16 |
數量 Quantity |
2kg |
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檢驗依據 Reference Standard |
企標 |
包裝 Packing |
2kg/bag |
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檢驗項目 TEST |
質量標準 ACCEPTANCE CRITERIONS |
檢驗結果RESULTS |
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鑒別 Identification |
A:IR |
符合規定 conform |
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性狀 Characteristics |
白色或類白色結晶性粉末 White or off-white crystalline powder |
符合規定 conform |
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溶解度solubility |
溶于乙醇，丙酮，略溶于乙醚，氯仿。不溶于水 Soluble in ethyl alcohol,acetone,slight sol in ether,chloroform,insoluble in water |
符合規定 conform |
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熔點Melting point |
223.0 ~ 229.0℃ |
223.1-223.8℃ |
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比旋度 Specific rotation |
﹢51.0°~﹢56.0° |
﹢52.1° |
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含量Assay |
97 .0~ 103.0% |
99.50% |
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干燥失重 Loss on drying |
≤3.0% |
0.05% |
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有關物質 Related substances |
any individual impurity ≤0.2% total impurities ≤1.0% |
0.16% 0.76% |
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殘留溶劑 Residual solvents |
乙酸乙酯ethyl acetate≤5000ppm 乙醇ethyl alcohol ≤5000ppm |
102ppm 58ppm |
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粒度 Particle size |
100%≤20μm |
100%≤20μm |
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結論 Conclusion |
符合以上標準 Conform the above standards |
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