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質量報告單
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
鹽酸沙拉沙星 Sarafloxacin hydrochloride |
批 號 Batch No |
2022.06.05 |
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數 量 Quantity |
426.0KG |
生產日期 MFG. Date |
2022.08.06 |
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化驗日期 Test Date |
2022.08.08 |
有 效 期 Exp Date |
2024.08.09 |
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執行標準 Quality standard |
獸藥質量標準2003年版 |
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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 Description |
類白色至淡黃結晶性粉末 White to yellowish crystalline powder |
合格 Pass |
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無臭、味味苦Odorless, bitter taste |
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鑒別 Identification |
（1）丙二酸-醋酸酐試驗：溶液顯紅棕色。 Malonic acid - acetic anhydride test: the solution was red-brown |
符合規定 Conform to prescribed |
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UV：在274nm、323nm、334nm處應有最大吸 UV: at 274nm, 323nm, 334nm absorption maximum at the proper |
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R：紅外光吸收圖譜應與對應的圖譜一致 IR: Infrared absorption spectrum should be consistent with the corresponding map |
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應顯氯化物的鑒別反應 should be significant differential response chlorides |
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含量（干品） Assay（on dry basis） |
按干燥品計算，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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熾灼殘渣 Residue on ignition |
≤0.2% |
0.14% |
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酸度 Acidity |
3.0~5.0 |
4.2
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重金屬 Heavy metals |
≤20ppm |
合格 Pass |
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溶液澄清度Clarlty |
應澄清 Cleat |
合格 Pass |
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溶液顏色Colour |
小于黃色或黃綠色3號標準液 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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有關物質 Related substances |
各雜質蜂面積的和不得大于總蜂面積的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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結論 Conclusion |
符合 Conforns |
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