国产优质乳酸环丙沙星出口韩国朝鲜质量标准数据
质量报告单
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
乳酸环丙沙星Ciprofloxacin lactate |
批 号 Batch No |
2020.06.05 |
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数 量 Quantity |
2500.0KG |
生产日期 MFG. Date |
2020.06.05 |
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化验日期 Test Date |
2020.06.05 |
有 效 期 Exp Date |
2022.06.04 |
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执行标准 Quality standard |
兽药国家标准（化学药品、中药卷）第一册 |
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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 Description |
类白色至淡黄结晶性粉末 White to yellowish crystalline powder |
合格 Pass |
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无臭、味味苦，有引湿 Odorless, bitter, tastehygroscopicty |
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鉴别 Identification |
（1）碘化铋钾试验：成橙黄色沉淀。 Potassium iodide, bismuth test: a yellow-orange precipitate. |
符合规定 Conform to prescribed |
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UV: at 277nm, absorption maximum at the proper |
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IR: Infrared absorption spectrum should be consistent with the corresponding map |
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Differential response should be significantly lactate |
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含量（干品） Assay（on dry basis） |
按干燥品计算， ≥98.0% ≥98.0%(On dned tasis） |
99.1% |
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干燥失重 Loss on drying |
≤6.5%（60°C) |
4.4% |
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炽灼残渣 Residue on ignition |
≤0.1% |
0.06% |
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酸度 Acidity |
4.5~5.5 |
4.8
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重金属 Heavy metals |
≤20ppm |
合格 Pass |
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溶液澄清度Clarlty |
应澄清 Cleat |
合格 Pass |
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溶液颜色Colour |
在430nm处吸收度≤0.05 absorbance at ≤0.05 at430nm |
合格 Pass |
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氟 Fluoride |
≧4.2% |
4.5% |
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有关物质 Related substances |
单个最大杂质峰 impurity ≤0.5% 总杂质 of each impurities ≤1.0% |
合格 Pass |
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结论 Conclusion |
符合 Conforns |
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