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質(zhì)檢報(bào)告單——CERTIFICATE OF ANALYSIS |
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產(chǎn)品名稱 Product Name |
賴諾普利 Lisinopril dihydrate |
產(chǎn)品批號(hào) Batch No. |
230309 |
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批次數(shù)量 Quantity |
114.26KG |
生產(chǎn)日期 Man. Date |
2023-03-11 |
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包裝規(guī)格 Packaging |
25KG/紙桶/Drum |
檢測(cè)日期 Test Date |
2023-03-21 |
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有效日期 Expiry Date |
2026-03-10 |
報(bào)告日期 Report Date |
2023-03-23 |
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檢驗(yàn)項(xiàng)目 Test Items |
檢驗(yàn)指標(biāo) Standard |
檢驗(yàn)結(jié)果 Test Results |
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性狀 Characteristics |
白色或幾乎白色的結(jié)晶粉末 White or almost white crystalline powder |
符合規(guī)定 Complies |
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溶解度 Solubility |
符合規(guī)定 Complies |
符合規(guī)定 Complies |
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鑒別 Identification |
A、B 符合規(guī)定 Complies |
符合規(guī)定 Complies |
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水分 Water |
8.0~9.5% |
8.6% |
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有關(guān)物質(zhì) Related substances |
雜質(zhì) A Impurity A≤0.2%雜質(zhì) E Impurity E≤0.2%雜質(zhì) F Impurity F≤0.2%雜質(zhì) GImpurity G≤0.15% 未指明雜質(zhì) Unspecified impurities≤0.10% 總雜質(zhì) 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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殘留溶劑 Residual solvents |
≤5000ppm |
420ppm |
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含量 Assay |
98.5~101.5%(干品計(jì),on dried basis) |
99.6% |
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結(jié)論 Conclusion |
本品符合 EP10.0 質(zhì)量標(biāo)準(zhǔn) Complies with EP10.0 standard |
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