*兽用药品*盐酸沙拉沙星Sarafloxacin质检单中英文版
质量报告单
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
盐酸沙拉沙星 Sarafloxacin hydrochloride |
批 号 Batch No |
2022.06.05 |
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数 量 Quantity |
426.0KG |
生产日期 MFG. Date |
2022.08.06 |
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化验日期 Test Date |
2022.08.08 |
有 效 期 Exp Date |
2024.08.09 |
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执行标准 Quality standard |
兽药质量标准2003年版 |
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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Odorless, bitter taste |
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鉴别 Identification |
（1）丙二酸-醋酸酐试验：溶液显红棕色。 Malonic acid - acetic anhydride test: the solution was red-brown |
符合规定 Conform to prescribed |
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UV：在274nm、323nm、334nm处应有最大吸 UV: at 274nm, 323nm, 334nm absorption maximum at the proper |
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R：红外光吸收图谱应与对应的图谱一致 IR: Infrared absorption spectrum should be consistent with the corresponding map |
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应显氯化物的鉴别反应 should be significant differential response chlorides |
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含量（干品） Assay（on dry basis） |
按干燥品计算，含C20H18ClF2N3O3.HCL ≥98.0% ≥98.0%(On dned tasis） |
99.3% |
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干燥失重 Loss on drying |
≤8.0%（50°C) |
6.6% |
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炽灼残渣 Residue on ignition |
≤0.2% |
0.14% |
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酸度 Acidity |
3.0~5.0 |
4.2
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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 |
小于黄色或黄绿色3号标准液 Less than yellow or yellow-green on the 3rd standard solution |
合格 Pass |
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氟 Fluoride |
≧8.1% |
8.3% |
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有关物质 Related substances |
各杂质蜂面积的和不得大于总蜂面积的3.0% 3.0% of each impurity bee area and shall not be greater than the total area of bee |
合格 Pass |
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结论 Conclusion |
符合 Conforns |
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