氨苄西林三水物/7177-48-2/质量信息COA
质量报告单
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
氨苄西林 Ampicillin trihydrate |
批 号 Batch No |
20220814 |
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数 量 Quantity |
40千克 40kg |
包 装 Packing |
20千克/桶 20kg/drum |
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生产日期 MFG. Date |
2022.08.14 |
有 效 期 Exp. Date |
2024.08 |
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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 Characteristic |
白色结晶性粉末 A white crystalline powder |
白色结晶性粉末 A white crystalline powder |
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鉴别Certification |
与对照品的红外图谱一致 Identical with IR spectrum of CRS |
与对照品的红外图谱一致Conforms |
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含量（按干品计）Assay(on the anhydrous substance) |
≥96.0% |
99.26% |
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Water |
12.0%-15.0% |
13.16% |
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溶解度Appearance of solution |
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在盐酸溶液中In hydrochloric acid |
≤2号（not more than reference suspenaion II） |
0.5号 |
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在氧化铵溶液中In aqueous ammonin |
≤2号（not more than reference suspenaion II） |
0.5号 |
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酸值（PH） |
3.5～5.5 |
4.42 |
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transnittance |
≥85% |
96.90% |
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溶液的颜色Color of solution |
≤1号（not more than reference suspenaion I） |
1号 |
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旋光度（specific optical rotation） |
+280o～+305o |
+300.1o |
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N，N-二甲基苯胺N,N-Dimethylaniline |
≤20ppm |
＜0.10ppm |
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炽灼残渣Residue on ignition |
≤0.5% |
0.10% |
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重金属Heavy metals |
≤20ppm |
符合规定 |
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有关物质related substances |
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最大单个杂质含量 （maximum individual impurity） |
≤1.0% |
0.29% |
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总杂质含量（Total impurity） |
≤3.0% |
0.77% |
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二氯甲烷(Methylene chloride) |
≤0.2% |
0.07% |
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细菌内毒素(Bacterial endotoxins) |
＜0.10EU/mg |
符合规定 |
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