培哚普利左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DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.124423444256440774461644516443400.50
29.944408044313441960.38
单位质量响应值RSD%判断
4381.424446.281.04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
2024052721批149517500664979297.3497.501.2096.28%～98.73%
250590491714988097.51
350862509535090899.52
449379507025004097.82
549215497994950796.78
648995492674913196.05
2024052721批1525705262052595102.82101.122.0798.92%～103.31%
250881506355075899.23
3517995183151815101.29
4528035345253128103.86
5514795203151755101.18
650665499165029098.31
2024052721批1512055139851302100.2999.681.9397.66%～101.69%
2523805115751768101.20
3521225195652039101.73
4514755099851236100.16
549726494124956996.90
649822502155001897.78
培哚普利左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8000
标示量(mg)2.5 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%
114.013901539677390363910439228392120.70
214.073919639333392640.25
单位质量响应值RSD%判断
2798.862790.620.21数据可信
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
2024052721批142128432374268296.4397.772.2495.48%～100.06%
244369435084393899.26
3448604478944824101.27
443316434134336497.97
542197424934234595.66
642697423024250096.02
2024052721批1460814688146481105.01102.222.4299.63%～104.81%
2461004505745578102.97
3450644568645375102.51
4463234600846166104.30
544108441104410999.65
644182433594377098.88
2024052721批1440254500944517100.5799.591.3698.17%～101.01%
243749440194388499.14
3445094545944984101.63
444497430944379698.94
543971441424405699.53
643235433064327097.75
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