培哚普利氨氯地平片项目信息
介质体积(ml)1000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%
110.442114121177212922139521228212470.48
210.432133321103212180.77
单位质量响应值RSD%判断
2035.152034.320.03数据可信
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
2022081901120640206902066596.2896.571.4695.09%～98.05%
220935209892096297.66
320991207492087097.23
420647205252058695.91
520268201882022894.24
620915211962105698.10
2022082001121402212712133699.4199.531.6297.84%～101.22%
220674207692072296.55
321411212662133899.42
4215812160321592100.60
5219812143621708101.14
6214462150821477100.06
2022082101121529213882145899.97100.080.8199.24%～100.93%
221137213182122898.90
3216412172421682101.02
421366213132134099.42
5217532140221578100.53
6216742153521604100.65
培哚普利氨氯地平片项目信息
介质体积(ml)1000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%
113.988156781592815088168381782816260.14
213.998134081408813740.06
单位质量响应值RSD%判断
5838.775816.580.27数据可信
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
2022081901177864782677806696.4996.651.2995.34%～97.96%
278911792857909897.76
378675786937868497.25
477592778297771096.05
576777762107649494.54
678949793017912597.80
2022082001180335798638009999.0098.681.6097.03%～100.33%
277820773007756095.86
379459794207944098.19
480187802948024099.17
5812628137281317100.51
680485803188040299.37
2022082101180269806488045899.4498.840.9897.83%～99.86%
278282789127859797.14
380224800308012799.03
479901793927964698.44
580810808798084499.92
680108802388017399.09
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