盐酸雷诺昔芬Raloxifene HCl丨COA
CERTIFICATE OF ANALYSIS
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产品名称 Product Name |
Raloxifene HCl |
CAS |
82640-04-8 |
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批号 Batch No. |
22050901 |
生产日期 Producing Date |
2022-05-09 |
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数量 Quantity |
50kg |
复测期 Retest Date |
2024-05-08 |
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项目 Items |
标准 Standard |
结论 Results |
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外观 Appearance |
类白色或浅黄色粉末 Almost white or pale-yellowish powder |
符合 Comply |
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鉴别 Identification |
IR |
符合 Comply |
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氯化物 It meets the requirements of the test for Choride |
符合 Comply |
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溶解性 Solubility |
溶于10%的氢氧化钠溶液，略溶于甲醇，不溶于水 Soluble in 10% sodium hydroxide solution, slightly soluble in methanol, insoluble in water |
符合 Comply |
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有关物质 Related Substances |
有关物质I≤0.2% ImpurityⅠ≤0.20% |
≤0.2% |
0.18% |
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其它单个杂质 Other single impurity |
≤0.1% |
0.06% |
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总杂质 Total impurities |
≤0.5% |
0.38% |
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干燥失重 Loss on drying |
≤0.5% |
0.20% |
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灼烧残渣 Residue on ignition |
≤0.1% |
0.04% |
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重金属 Heavy metals |
≤10ppm |
符合 Comply |
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有机残留 Residual solvents |
甲醇≤ 3000ppm |
符合 Comply |
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二氯甲烷≤600ppm |
符合 Comply |
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含量 Assay |
97.5%～102.0% |
99.2% |
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结论 Determination |
符合USP40标准 Complies with USP40 standard |
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