Ulipristal Acetate CAS:126784-99-4
3,20-Bis(ethylenedioxy)-19-norpregna-5(10),9(11)-dien-17-ol CAS:54201-84-2
成品检验报告单
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产品名称 Product Name |
醋酸乌利司他 Ulipristal acetate |
CAS No. |
126784-99-4 |
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产品批号 Batch No. |
150601 |
生产日期 Mfg. Date |
2015/06/10 |
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报告日期 Report Date |
2015/06/11 |
有效期至 Exp. Date |
2017/06/09 |
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数量 Quantity |
9.2Kg |
检验依据 Quality Standard |
企业标准 Enterprise Standard |
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检验项目 TEST |
标准规定 SPECIFICATIONS |
检验结果 RESULTS |
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外观 Appearance |
白色至淡黄色结晶性粉末 White or light yellow crystalline powder |
淡黄色结晶性粉末 Light yellow crystalline powder |
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熔点 Melting point |
183-188℃ |
185-188℃ |
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溶解性 Solubility |
本品在二氯甲烷中易溶，在甲醇中略溶，在乙酸乙酯中溶解，在水中几乎不溶Feely soluble in methylene chloride,sparingly soluble in methanol, soluble in ethyl acetate，Almost insoluble in water。 |
符合规定 Conforms |
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鉴别 Identification |
1 |
紫外鉴别UV identification |
Conforms |
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2 |
红外鉴别IR identification |
Conforms |
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比旋度 Specific rotation |
+192.0°～+202.0° |
+195.8° |
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有关物质 Related substances |
≤1.0% |
0.15% |
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最大未知单一杂质 Max unknown single impurity |
≤0.1% |
0.03% |
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杂质A Impurity A |
≤0.3% |
0.01% |
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醋酸 Acetic acid |
≤0.5% |
N.D. |
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干燥失重 Loss on drying |
≤0.5% |
0.30% |
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炽灼残渣 Residue on ignition |
≤0.1% |
0.06% |
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重金属 Heavy metal |
≤10ppm |
≤10ppm |
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残留溶剂 Residual solvent |
四氢呋喃 THF≤0.072％ |
0.002% |
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乙酸乙酯Ethyl acetate≤0.5％ |
0.007% |
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乙醇Ethanol≤0.5％ |
N.D. |
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异丙醇 Isopropanol≤0.5％ |
N.D. |
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二氯甲烷 Dichloromethane≤0.06％ |
N.D. |
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含量 Assay |
≥98.5% |
99.38% |
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结论 Conclusion |
本品按企业标准检验，结果符合规定。 The results conform to the Enterprise standard |
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