盐酸伐地那非片项目信息
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.333676633672443673783670963676183674000.07
212.363680313678713679510.04
单位质量响应值RSD%判断
29797.2429769.500.07数据可信
加速3月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121138731838720838726398.5694.189.9584.35%~104.02%
2435403434616435010110.71
336709436702836706193.42
434267634305034286387.26
535318435320835319689.89
633534933477633506285.27
2024030221137460737474037467495.35102.893.6898.91%~106.86%
2410143410297410220104.40
3415409415861415635105.78
4410983411399411191104.65
5406149405709405929103.31
6408062407972408017103.84
20240303211393592393244393418100.1293.156.5186.79%~99.51%
238661938663238662698.39
335995936022036009091.64
433447833433433440685.10
537785837761637773796.13
634405534369934387787.52
盐酸伐地那非片项目信息
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.333671633673023673803673643673283673070.03
212.363671723669523670620.05
单位质量响应值RSD%判断
29789.7029697.570.22数据可信
长期3月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211404319404552404436103.0695.978.3087.62%~104.32%
2409775409705409740104.42
332958732990332974584.03
435201935209835205889.72
539034839045139040099.49
637318437302037310295.08
2024030221137313437211837262694.9699.415.6693.50%~105.32%
2399801399939399870101.90
336755736771936763893.69
437140637162337151494.68
5415640415479415560105.90
6413312413357413334105.33
2024030321136276936268436272692.4496.365.8390.47%~102.26%
234635034648234641688.28
336927736941236934494.12
4392968392946392957100.14
5393875394047393961100.40
6403630403193403412102.80
盐酸伐地那非片项目信息
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.333679763678183675933675343676653677170.05
212.363679353682803681080.07
单位质量响应值RSD%判断
29822.9529782.200.10数据可信
中间条件3月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121137697937695637696895.8796.906.1390.67%~103.13%
2410821411210411016104.53
336393936369036381492.53
435427635444735436290.13
5407991407770407880103.74
637190937209637200294.61
2024030221136238636258936248892.1994.105.0189.16%~99.05%
236959636908436934093.93
338452138475638463897.83
4398690398703398696101.40
535364035354235359189.93
635127035129335128289.34
2024030321138126838104038115496.94101.263.5497.51%~105.02%
239225139188539206899.72
338423038449638436397.76
4413801413451413626105.20
5407101407063407082103.53
6410753410576410664104.44
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