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质量报告单
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
非那雄胺（Finasteride） |
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规 格 Specification |
1 kg/Tin |
批 号 Batch No |
20190528 |
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数 量 Quantity |
1kg |
生产日期 MFG. Date |
2019.05.28 |
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检验标准 Test Standard |
According to USP37 |
有效日期 Exp Date |
2021.05.28 |
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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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性状 Description |
白色或类白色结晶性粉末 White or off-white crystalline powder |
类白色结晶性粉末 Off-white crystalline powder |
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比旋度 Specific rotation |
-56°~-60° |
-58.2° |
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鉴别 Identification |
IR |
Matches with working standard |
Complies |
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HPLC |
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溶解性 Solubility |
Freely soluble in chloroform and in alcohol; Very slightly soluble in water |
Conform |
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重金属 Heavy metals |
≤10ppm |
＜10ppm |
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水分 Water |
≤0.3% |
0.22% |
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灼烧残渣 Residue on ignition |
≤0.1% |
0.05% |
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相关物质 Relative material |
最大杂质≤0.5% |
0.36% |
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总杂质≤1.0% |
0.52% |
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含量Assay |
98.5~101.0% |
99.48% |
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结论 Conclusion |
符合USP37 Passed |
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质保部主管（Director）： 复核员(tester)： 化验员(Retester)：
