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質(zhì)量報告單
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
氟康唑 Fluconazole |
批 號 Batch No |
20210824 |
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生產(chǎn)日期 MFG. Date |
2021.08.24 |
有 效 期 Exp. Date |
2023.08 |
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檢驗依據(jù) Pef. standard |
中華人民共和國藥典2010版標準 The standard of CP2010 |
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檢驗項目 Test Items |
檢驗指標 Specification |
檢驗結(jié)果 Test Results |
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性狀Characteristics |
白色或類白色結(jié)晶性粉末 White crystalline powder |
符合規(guī)定 Conforms |
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熔點Melting Point |
137-141℃ |
139.7-140.8℃ |
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鑒別Identification |
λmin=261nm ②紅外光吸收圖譜應與對照圖譜一致 ③本品顯有機氟化物的鑒別反應 |
符合規(guī)定Conforms
符合規(guī)定Conforms 符合規(guī)定Conforms |
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氟 Fluorine |
應為11.1%-12.4% |
11.8% |
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含氯化合物Chloride |
≤0.3% |
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有關(guān)物質(zhì)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 |
符合規(guī)定Conforms |
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熾灼殘渣Residue on ignition |
≤0.1% |
0.04% |
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重金屬Heavy metals |
≤0.002% |
符合規(guī)定Conforms |
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含量（按干品計）Assay(on dried basis) |
≥98.5% |
99.3% |
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檢驗結(jié)論Conclusion |
符合中華人民共和國藥典2010版標準規(guī)定 Accords with the standard of CP2010 |
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