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*有机化学原料*氟康唑86386-73-4东康源售价及品质
质量报告单
CERTIFICATE OF ANALYSIS
|
品 名 Product Name |
氟康唑 Fluconazole |
批 号 Batch No |
20210824 |
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生产日期 MFG. Date |
2021.08.24 |
有 效 期 Exp. Date |
2023.08 |
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检验依据 Pef. standard |
中华人民共和国药典2010版标准 The standard of CP2010 |
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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Characteristics |
白色或类白色结晶性粉末 White crystalline powder |
符合规定 Conforms |
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熔点Melting Point |
137-141℃ |
139.7-140.8℃ |
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鉴别Identification |
λmin=261nm ②红外光吸收图谱应与对照图谱一致 ③本品显有机氟化物的鉴别反应 |
符合规定Conforms
符合规定Conforms 符合规定Conforms |
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|
氟 Fluorine |
应为11.1%-12.4% |
11.8% |
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含氯化合物Chloride |
≤0.3% |
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有关物质Related Substance |
≤1.0% |
0.27% |
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干燥失重Loss on drying |
≤0.5% |
0.19% |
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澄清度Solubility |
澄清 Solution |
符合规定Conforms |
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炽灼残渣Residue on ignition |
≤0.1% |
0.04% |
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重金属Heavy metals |
≤0.002% |
符合规定Conforms |
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含量（按干品计）Assay(on dried basis) |
≥98.5% |
99.3% |
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检验结论Conclusion |
符合中华人民共和国药典2010版标准规定 Accords with the standard of CP2010 |
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