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分析證明
Certificate of Analysis
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品名Product Name |
十一酸雌二醇Estradiol undecanoate CAS:3571-53-7 |
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生產日期 Manufacturing Date |
2024/05/12 |
批號 Batch No. |
202405001 |
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有效期 Expiry Date |
2026/05/11 |
數量 Quantity |
500g |
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檢驗依據 Reference Standard |
企標 Company standard |
包裝 Packing |
100g/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 B:UV C:TLC B utraviolet absorption Absorptivitles at 281nm,calculated on the dried dasis,do not differ by more than 3.0% |
符合規定 Conform 符合規定 conform |
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性狀 Characteristics |
白色粉末 White crystalline powder |
符合規定 conform |
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溶解度solubility |
不溶于水，溶于乙醇，丙酮、二氧六環、氯仿，微溶于植物油 ,practiclly insoluble in water,Soluble in alcohol,acetone,dioxane,chloroform;sparingly soluble in vegetable oils. |
符合規定 conform |
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熔點Melting point |
About 110℃ |
109.8-110.6℃ |
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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 |
≤0.50% |
0.21% |
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雜質總量 Total related substance |
≤2.0% |
0.38% |
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單一雜質 Any individual impurity |
≤0.50% |
0.12% |
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灼燒殘渣 Residue ignition |
≤0.10% |
0.08% |
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純度Putity |
≥99.0% |
99.62% |
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結論 Conclusion |
本品按企業標準檢驗，結果符合規定 Company standard,conform the stipulation. |
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