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質(zhì)量報(bào)告單
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
氨芐西林 Ampicillin trihydrate |
批 號(hào) Batch No |
20220814 |
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數(shù) 量 Quantity |
40千克 40kg |
包 裝 Packing |
20千克/桶 20kg/drum |
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生產(chǎn)日期 MFG. Date |
2022.08.14 |
有 效 期 Exp. Date |
2024.08 |
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檢驗(yàn)項(xiàng)目Test Items |
檢驗(yàn)指標(biāo)Specification |
檢驗(yàn)結(jié)果Test Results |
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外觀 Characteristic |
白色結(jié)晶性粉末 A white crystalline powder |
白色結(jié)晶性粉末 A white crystalline powder |
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鑒別Certification |
與對(duì)照品的紅外圖譜一致 Identical with IR spectrum of CRS |
與對(duì)照品的紅外圖譜一致Conforms |
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含量（按干品計(jì)）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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在鹽酸溶液中In hydrochloric acid |
≤2號(hào)（not more than reference suspenaion II） |
0.5號(hào) |
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在氧化銨溶液中In aqueous ammonin |
≤2號(hào)（not more than reference suspenaion II） |
0.5號(hào) |
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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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溶液的顏色Color of solution |
≤1號(hào)（not more than reference suspenaion I） |
1號(hào) |
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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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熾灼殘?jiān)黂esidue on ignition |
≤0.5% |
0.10% |
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重金屬Heavy metals |
≤20ppm |
符合規(guī)定 |
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有關(guān)物質(zhì)related substances |
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最大單個(gè)雜質(zhì)含量 （maximum individual impurity） |
≤1.0% |
0.29% |
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總雜質(zhì)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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細(xì)菌內(nèi)毒素(Bacterial endotoxins) |
＜0.10EU/mg |
符合規(guī)定 |
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