培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2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%
115.941530081529221527501528261528231528660.07
216.041529611531171530390.08
单位质量响应值RSD%判断
9590.099541.080.37数据可信
长期24月-供试品溶液-培哚普利-pH2.0(内含0.19g/L的EDTA)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023110721批1157006156965156986102.37102.361.39100.87%～103.84%
2160416160746160581104.71
3156765156874156820102.26
4154362154438154400100.68
5155133155207155170101.18
6157786157898157842102.93
2023110821批115168615167415168098.91100.802.1098.59%～103.02%
2156736156655156696102.18
3159975160160160068104.38
415198515185815192299.07
5153749153894153822100.30
615335215330515332899.98
2023110921批115222415217515220099.2599.961.6498.24%～101.68%
215105015106815105998.50
3155573155492155532101.42
415232615278615255699.48
5157113157288157200102.51
615119715123315121598.60
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.692887132889672887412887862886992887810.04
212.622885372886642886000.04
单位质量响应值RSD%判断
22756.5822868.460.35数据可信
长期24月-供试品溶液-吲达帕胺-pH2.0(内含0.19g/L的EDTA)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023110721批127013526997427005493.0096.362.0794.28%～98.45%
228759428728728744098.99
327747827757227752595.57
428052428049128050896.60
528227428166028196797.10
628141728149528145696.93
2023110821批128253328276228264897.3495.861.8893.97%～97.74%
227166627180427173593.58
328552128587628569898.39
427429027410227419694.43
527702627684527693695.37
627910827866227888596.04
2023110921批128759328792628776099.1096.222.0494.16%～98.28%
227757127751627754495.58
328112528109928111296.81
427434227442927438694.49
528324028296328310297.49
627237927274127256093.86
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