培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.834039239972401314021540176401770.38
29.894012940208401680.14
单位质量响应值RSD%判断
4087.184061.480.45数据可信
长期9月-供试品溶液-培哚普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121147109471144711298.6698.331.2397.07%~99.59%
246094460084605196.44
347560474354749899.47
446625464054651597.41
547068470094703898.50
647506475124750999.49
20240302211480204787747948100.4198.441.9596.43%~100.45%
245471454374545495.19
346707467944675097.90
447527476734760099.68
546671466764667497.74
647626476164762199.72
20240303211488414883848840102.2898.952.0296.85%~101.04%
246414463384637697.12
347216474284732299.10
447530476064756899.61
546363460104618696.72
647237471734720598.85
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.081644611648921645711647181646321646550.10
214.081646521648101647310.07
单位质量响应值RSD%判断
11694.2511699.640.04数据可信
长期9月-供试品溶液-氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121117499017470217484696.9096.450.7895.66%~97.23%
217473917480117477096.86
317493717422217458096.75
417151217178717165095.13
517317617317517317695.98
617501117528917515097.07
2024030221117598217650817624597.6896.831.1295.69%~97.97%
217240717288317264595.68
317664117679117671697.94
417539717525617532697.17
517207317182917195195.30
617518217562617540497.21
2024030321117977617948717963299.5596.351.8694.48%~98.23%
216967016978516972894.06
317321317366317343896.12
417317817292617305295.91
517411417432117421896.55
617305817308417307195.92
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