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質量報告單
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
硝酸咪康唑 Econazole Nitrate |
批 號 Batch No |
20191008 |
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數 量 Quantity |
200kgs |
包 裝 Packing |
25kgs/紙板桶 25kgs/drum |
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生產日期 MFG. Date |
2019.10.08 |
有 效 期 Exp Date |
2021.10.07 |
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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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外觀Appearance |
白色或類白色結晶粉末 White or Almost white powder |
符合規定 Complies |
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鑒別 Identification |
紅外光譜吸收 IR |
與標準相近Similar to standard |
符合規定 Complies |
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溶液澄清度 Appearance of Solution |
溶液清澈，色澤不深于標準液 The solution is clear and not more intensely cloured than reference solutions |
符合規定 Complies |
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溶解性Solubility |
難溶于水，溶于甲醇，微溶于乙醇 Very slightly soluble in water; soluble in methanol ; slightly soluble in alcohol |
符合規定 Complies |
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旋光度 Angle of optical rotation |
-0.1o～+0.1o |
符合規定 Complies |
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相關物質(HPLC) Related Substances |
單個雜質 Each Impurity |
≤0.25% |
0.18% |
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雜質總和 Total Impurity |
≤0.5% |
0.25% |
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熔點Melting Point |
163～167℃ |
164.5℃ |
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干燥失重Loss on Drying |
≤0.5%（105℃2小時） |
0.32% |
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熾灼殘渣Residue on Ignition |
≤0.1% |
0.01% |
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含量（干基）Assay (on dry basis) |
98.0～102.0% |
99.38% |
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結論 Conclusion |
本品符合USP35/BP2007標準 Conform to the specification of USP35/BP2007 |
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