左氨氯地平贝那普利胶囊项目信息
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%
114.114371164371404372434371384370124371300.02
214.134359444360174359800.02
单位质量响应值RSD%判断
30980.1630854.920.29数据可信
加速1月-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
2024030121142514442492942503696.4497.421.9395.45%～99.38%
242678242643942661096.80
3446213444757445485101.08
442683042689342686296.86
542949742960942955397.47
642235442249842242695.85
2024030221143488643508543498698.70100.331.8198.43%～102.23%
243705643707943706899.17
3446190446286446238101.25
443593043584843588998.91
5442982443080443031100.53
6455888455671455780103.42
2024030321143931643917943924899.6799.480.5598.91%～100.04%
244007543991343999499.84
343822043831243826699.44
443648643623743636299.01
5441787441220441504100.18
643533443478143505898.72
左氨氯地平贝那普利胶囊项目信息
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%
19.638022308017568019628020368021498020270.03
29.598015008011228013110.04
单位质量响应值RSD%判断
83284.2283556.930.24数据可信
加速1月-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
20240301211845629845820845724100.57100.270.8599.38%～101.16%
2848285848524848404100.89
3847792848273848032100.84
4841182841611841396100.06
5845779846111845945100.60
682942182974082958098.65
2024030221180425980401580413795.6298.412.8695.46%～101.36%
281116081087381101696.44
3857215857437857326101.95
480764980773280769096.05
583166283201683183998.92
6853409853324853366101.48
2024030321182528182586482557298.1798.452.0096.38%～100.51%
283893183825783859499.72
3848583848949848766100.93
481863581830881847297.33
583448583383783416199.19
680203380149080176295.34
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