左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.614196584191514193604201404198894196400.10
213.634272964261974267460.19
单位质量响应值RSD%判断
30833.2131309.321.09数据可信
供试品溶液-左氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024071721批143036043049643042897.1997.441.7095.71%～99.18%
242656042636342646296.29
342195742040242118095.10
443884043953343918699.17
544002844017644010299.37
643125043282643203897.55
2024071921批144175944097144136599.66100.261.1399.07%～101.44%
2446178446943446560100.83
344183944153944168999.73
4443457443935443696100.18
543762543893343827998.96
6452402452666452534102.18
2024072121批142940042926242933196.9497.260.9696.29%～98.24%
243375743446743411298.02
342353042422642387895.71
442934342902342918396.91
543375943309343342697.87
643445543462443454098.12
左氨氯地平贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.068380828378118360288361388365308369180.12
210.078499098516718507900.15
单位质量响应值RSD%判断
83192.6484487.591.10数据可信
供试品溶液-贝那普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024071721批1852483852601852542100.88100.410.7899.59%～101.23%
2855737855640855688101.25
384629084352284490699.98
484021483940083980799.37
5854340855098854719101.14
684345484418084381799.85
2024071921批181606081757081681596.6598.011.5396.44%～99.58%
282705882735182720497.88
382848282770382809297.99
481378481316581347496.26
583515783738283627098.95
6847276848540847908100.33
2024072121批181973281928881951096.9798.290.9497.33%～99.25%
283159382959183059298.28
383256883239483248198.51
482443282456582449897.56
583525783641383583598.90
684061084125884093499.51
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