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質檢報告單——CERTIFICATE OF ANALYSIS
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產品名稱 Product Name |
利福布汀 Rifabutin |
產品批號 Batch No. |
221219-2 |
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批次數量 Quantity |
56KG |
生產日期 Man. Date |
2022-12-21 |
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包裝規格 Packaging |
15KG/紙桶/Drum |
檢測日期 Test Date |
2022-12-29 |
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有效日期 Expiry Date |
2024-12-20 |
報告日期 Report Date |
2022-12-30 |
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檢驗項目 Test Items |
檢驗指標 Standard |
檢驗結果 Test Results |
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外觀 Appearance |
紅紫色無定形粉末 Reddish-violet amorphous powder |
符合規定 Complies |
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鑒別 Identification |
A、B 符合規定 Complies |
符合規定 Complies |
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溶解性 Solubility |
溶于氯仿和甲醇，略溶于乙醇，極微溶于水 Soluble in chloroform and methanol, slightly soluble in ethanol, and very slightly soluble in water |
符合規定 Complies |
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水分 Water |
≤2.5% |
1.1% |
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N-異丁基哌酮 N-Isobutylpiperidone |
供試品溶液色譜圖中在 N-異丁基哌嚏酮 RF 值處的斑點不得深于 0.05mg/ml N-異丁基哌疇酮標準溶液獲得的色譜 圖中主斑點(0.5%) No spot in the chromatogram of the test solution at an RF value corresponding to that of N-isobutylpiperidone is more intense than that of the principal spot observed in the chromatogram obtained from the Standard solution containing 0.05 mg of N-isobutylpiperidone per mL (0.5%) |
符合規定 Complies |
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色譜純度 Chromatographic purity |
RRT0.5:≤1.0% RRT0.6:≤1.0% RRT0.8:≤1.0% RRT1.4:≤1.0% |
RRT0.5: 0.1% RRT0.6: 0.2% RRT0.8: 0.6% RRT1.4: 0.1% |
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其它任一雜質 Any other impurity≤0.5% |
0.2% |
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所有雜質峰和 The total of all impurity peaks≤3.0% |
1.6% |
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丙酮 Acetone≤5000ppm |
ND |
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吡啶 Pyridine≤200ppm |
ND |
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二氯甲烷 Dichloromethane≤600ppm |
183ppm |
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殘留溶劑 Residual solvent |
乙醇 Ethanol≤5000ppm 二甲基甲酰胺 Dimethylfbrmamide≤880ppm 乙二醇單甲醚 Ethylene glycol monomethyl ether≤50ppm |
271ppm ND ND |
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四氫吠喃 Tetrahydrofuran<720ppm |
ND |
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乙酸乙酯 Ethyl acetate≤5000ppm |
ND |
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環己烷 Cyclohexane≤3880ppm |
32ppm |
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含量 Assay |
950μg/mg~1020μg/mg（無水物計 on anhydrous） |
986μg/mg |
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結論 Conclusion |
本品符合 USP42 質量標準 Complies with USP42 standard |
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