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質 量 分 析 單
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
左旋氧氟沙星 levofloxacin |
數 量 Quantity |
100kg |
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批 號 Batch No |
20211213 |
報告日期 Report Date |
2021.12.13 |
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生產日期 MFG. Date |
2021.12.13 |
有 效 期 Exp. Date |
2023.12.12 |
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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Appearance |
淺黃色或黃色結晶性粉末Light yellow or yellowish white crystalline powder |
符合規定Conform |
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溶解度Solubility |
溶于三氯甲烷，微溶于甲醇和水Soluble in chloroform, slightly soluble in methanol and water |
符合規定Conform |
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鑒別 Identification |
紅外光吸收圖譜應與對照品的圖譜一致IR Similar to standard |
符合規定Conform |
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溶液的澄清度 Solution Clarity |
Clear |
符合規定Conform |
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溶液的顏色 Solution Color |
≤0.025 |
0.0065 |
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比旋度 Specific rotation |
-95o～-103o |
-97.2o |
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干燥失重 Loss on drying |
≤3.0% |
2.47% |
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熾灼殘渣 Residue on ignition |
|
0.04% |
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右旋體Limit nf(R)-oflx |
≤0.5% |
0.10% |
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重金屬Heavy metal |
≤20ppm |
符合規定Conform |
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有關物質Related substances |
單個雜質：individual impurity≤0.2% 總雜質:total impurity≤0.5% |
0.10% 0.22% |
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含量Assay |
≥98.5% |
99.2% |
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檢驗結論Conclusion |
符合企業標準規定 Conform to Enterprise Standard |
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≤0.2%
