缬沙坦左氨氯地平片项目信息
介质体积(ml)900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4000
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%
114.221177271170301166481168951167381170080.37
214.251170171167381168780.17
单位质量响应值RSD%判断
8228.418201.960.23数据可信
加速1月-供试品溶液-左氨氯地平-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121111722111720211721290.0889.541.5588.09%~91.00%
211535211525911530688.62
311981011983511982292.09
411552611533811543288.72
511510911503111507088.44
611625211615611620489.31
2024030221111390011444811417487.7589.891.6888.30%~91.47%
211715511765711740690.23
311848211833311840891.00
411749211744211746790.28
511925711923111924491.65
611501411504811503188.41
2024030321111255911270611263286.5686.911.5285.52%~88.29%
211585411553711569688.92
311080211009911045084.89
411262511270611266686.59
511393911377311385687.50
611327611306511317086.98
缬沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
115.784585081458621645834894586765458422645851550.03
215.804615648460477246102100.17
单位质量响应值RSD%判断
290567.49291785.440.30数据可信
加速1月-供试品溶液-缬沙坦-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121152080905206610520735099.6999.931.0998.79%~101.06%
2522468052248945224787100.03
3532113953234405322290101.89
452202635219566521991499.93
551525855154665515362598.66
651913165190303519081099.37
2024030221151882885186396518734299.31101.001.3299.60%~102.39%
2523398252339405233961100.20
3532077853198005320289101.85
4532614353232055324674101.94
5536224453626035362424102.66
6522489752234825224190100.01
2024030321150518175052732505227496.7296.661.6095.04%~98.27%
251754205176954517618799.10
349625814964292496343695.02
449972374995143499619095.65
551072245106725510697497.77
649966934998780499773695.68
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