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质量报告单
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
硝酸咪康唑 Econazole Nitrate |
批 号 Batch No |
20191008 |
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数 量 Quantity |
200kgs |
包 装 Packing |
25kgs/纸板桶 25kgs/drum |
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生产日期 MFG. Date |
2019.10.08 |
有 效 期 Exp Date |
2021.10.07 |
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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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外观Appearance |
白色或类白色结晶粉末 White or Almost white powder |
符合规定 Complies |
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鉴别 Identification |
红外光谱吸收 IR |
与标准相近Similar to standard |
符合规定 Complies |
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溶液澄清度 Appearance of Solution |
溶液清澈，色泽不深于标准液 The solution is clear and not more intensely cloured than reference solutions |
符合规定 Complies |
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溶解性Solubility |
难溶于水，溶于甲醇，微溶于乙醇 Very slightly soluble in water; soluble in methanol ; slightly soluble in alcohol |
符合规定 Complies |
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|
旋光度 Angle of optical rotation |
-0.1o～+0.1o |
符合规定 Complies |
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相关物质(HPLC) Related Substances |
单个杂质 Each Impurity |
≤0.25% |
0.18% |
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杂质总和 Total Impurity |
≤0.5% |
0.25% |
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熔点Melting Point |
163～167℃ |
164.5℃ |
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干燥失重Loss on Drying |
≤0.5%（105℃2小时） |
0.32% |
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炽灼残渣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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结论 Conclusion |
本品符合USP35/BP2007标准 Conform to the specification of USP35/BP2007 |
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