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
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 |