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質(zhì)量報告單
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
乳酸環(huán)丙沙星Ciprofloxacin lactate |
批 號 Batch No |
2020.06.05 |
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數(shù) 量 Quantity |
2500.0KG |
生產(chǎn)日期 MFG. Date |
2020.06.05 |
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化驗日期 Test Date |
2020.06.05 |
有 效 期 Exp Date |
2022.06.04 |
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執(zhí)行標準 Quality standard |
獸藥國家標準（化學藥品、中藥卷）第一冊 |
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檢驗項目 Test Items |
檢驗指標 Specification |
檢驗結(jié)果 Test Results |
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外觀 Description |
類白色至淡黃結(jié)晶性粉末 White to yellowish crystalline powder |
合格 Pass |
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無臭、味味苦，有引濕 Odorless, bitter, tastehygroscopicty |
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鑒別 Identification |
（1）碘化鉍鉀試驗：成橙黃色沉淀。 Potassium iodide, bismuth test: a yellow-orange precipitate. |
符合規(guī)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） |
按干燥品計算， ≥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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熾灼殘渣 Residue on ignition |
≤0.1% |
0.06% |
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酸度 Acidity |
4.5~5.5 |
4.8
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重金屬 Heavy metals |
≤20ppm |
合格 Pass |
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溶液澄清度Clarlty |
應(yīng)澄清 Cleat |
合格 Pass |
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溶液顏色Colour |
在430nm處吸收度≤0.05 absorbance at ≤0.05 at430nm |
合格 Pass |
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氟 Fluoride |
≧4.2% |
4.5% |
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有關(guān)物質(zhì) Related substances |
單個最大雜質(zhì)峰 impurity ≤0.5% 總雜質(zhì) of each impurities ≤1.0% |
合格 Pass |
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結(jié)論 Conclusion |
符合 Conforns |
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