酮洛芬/酮基布洛芬 22071-15-4现货纯粉原料质量指标检测结果分析
质量报告单
CERTIFICATE OF ANALYSIS
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品 名Product Name |
酮洛芬ketoprofen |
批 号Batch No |
20201215 |
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生产日期MFG. Date |
2020.12.15 |
出厂日期Sale Date |
2020.12.15 |
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有效期Expiry date |
3年3 years |
重量Quantity |
6.0kg |
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检验项目Test Items |
检验指标Specification |
检验结果Test Results |
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鉴别 Identification |
A.熔点melting point |
94-97 ℃ |
95.0℃ |
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B.紫外吸收光谱UV |
255nm处有最大吸收（max=255nm）,E1%1CM=615-680 |
254nm处有最大吸收（max=255nm）,E1%1CM=676 |
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C.红外吸收光谱IR |
与对照品图谱一致，corresponding to reference spectrum |
与对照品图谱一致，corresponding to reference spectrum |
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D 薄层色谱TCL |
与对照品R1值一致，corresponding to reference R1 |
与对照品R1值一致，corresponding to reference R1 |
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澄清度Clarity |
澄清（≤Ref.Susp.I）,clear |
澄清（≤Ref.Susp.I）,clear |
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颜色color |
不深于对照液，≤Y6 |
不深于对照液，≤Y6 |
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有关物质 杂质impurityC 杂质impurityE 杂质impurityB 杂质impurityD 杂质impurityA 杂质impurityF 其他单个杂质 Any other impurity 除杂质A和C外，其他杂质总和apart from A and C,other total |
≤0.2% ≤0.2% ≤0.2% ≤0.2% ≤0.2% ≤0.2% ≤0.10%
≤0.4%
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≤0.05% ≤0.05% ≤0.05% ≤0.05% ≤0.05% ≤0.05% ≤0.05%
≤0.05% |
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含量（on dried basis） % Assay |
99.0～100.5% |
99.8% |
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水分 % Water |
＜0.5% |
≤0.05% |
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重金属 % Heavy metals |
≤10ppm |
＜10ppm |
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硫酸化灰分sulphated ash |
≤0.1% |
≤0.04% |
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结论 Conclusion |
符合药典USP36版 Comply with USP36 |
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