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質量報告單
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
氟康唑 Fluconazole |
批 號 Batch No |
20240824 |
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生產日期 MFG. Date |
2024.08.24 |
有 效 期 Exp. Date |
2026.08 |
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檢驗依據 Pef. standard |
企業標準 Enterprise standards |
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檢驗項目 Test Items |
檢驗指標 Specification |
檢驗結果 Test Results |
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性狀Characteristics |
白色或類白色結晶性粉末 White crystalline powder |
符合規定 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 |
符合規定Conforms
符合規定Conforms 符合規定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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有關物質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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檢驗結論Conclusion |
企業標準 Enterprise standards |
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