赖诺普利二水合物,83915-83-7,COA
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质检报告单——CERTIFICATE OF ANALYSIS |
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产品名称 Product Name |
赖诺普利 Lisinopril dihydrate |
产品批号 Batch No. |
230309 |
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批次数量 Quantity |
114.26KG |
生产日期 Man. Date |
2023-03-11 |
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包装规格 Packaging |
25KG/纸桶/Drum |
检测日期 Test Date |
2023-03-21 |
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有效日期 Expiry Date |
2026-03-10 |
报告日期 Report Date |
2023-03-23 |
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检验项目 Test Items |
检验指标 Standard |
检验结果 Test Results |
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性状 Characteristics |
白色或几乎白色的结晶粉末 White or almost white crystalline powder |
符合规定 Complies |
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溶解度 Solubility |
符合规定 Complies |
符合规定 Complies |
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鉴别 Identification |
A、B 符合规定 Complies |
符合规定 Complies |
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水分 Water |
8.0~9.5% |
8.6% |
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有关物质 Related substances |
杂质 A Impurity A≤0.2%杂质 E Impurity E≤0.2%杂质 F Impurity F≤0.2%杂质 GImpurity G≤0.15% 未指明杂质 Unspecified impurities≤0.10% 总杂质 Total impurities≤0.5% |
ND ＜0.05% 0.10% 0.08% ＜0.05% 0.22% |
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硫酸灰分 Sulphated ash |
≤0.1% |
0.04% |
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残留溶剂 Residual solvents |
≤5000ppm |
420ppm |
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含量 Assay |
98.5~101.5%(干品计,on dried basis) |
99.6% |
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结论 Conclusion |
本品符合 EP10.0 质量标准 Complies with EP10.0 standard |
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