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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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%
111.813687373700353691423684843692033691200.17
211.833685393683723684560.04
单位质量响应值RSD%判断
31254.8731145.900.25数据可信
影响因素5天-供试品溶液-pH1.0盐酸溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024072521139455539427139441395.4296.754.0592.64%~100.86%
237106837073437090189.73
3416219416654416436100.74
440529340599140564298.13
540079540053040066296.93
641163541132941148299.54
2024073021138498738576638537693.2397.183.4393.68%~100.68%
239254239190539222494.89
3415329415666415498100.52
441233841279741256899.81
5413729414666414198100.20
639041439033439037494.44
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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%
111.813684743691563678093690013693063687490.17
211.833703683698813701240.10
单位质量响应值RSD%判断
31223.4531286.900.15数据可信
影响因素10天-供试品溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024072521140794740796740795798.5297.301.3195.97%~98.63%
240098640013340056096.73
340904440903940904298.78
439454939467139461095.30
540224340256040240297.18
640293040276240284697.28
2024073021136452636456136454488.0395.026.0089.04%~101.00%
236229836337836283887.62
3415434415253415344100.30
441071941125141098599.25
540661540680140670898.22
640004640062840033796.68
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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%
111.817397207393307396547381597403677394460.11
211.837392857416737404790.23
单位质量响应值RSD%判断
62611.8562593.320.03数据可信
影响因素5天-供试品溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024072521175547775490575519191.0594.844.1690.71%~98.98%
281245181059281152297.84
378698078504978601494.77
4828849829967829408100.00
574306374423074364689.66
679412479385279398895.73
20240730211870436871966871201105.04100.942.1698.67%~103.22%
2833839832324833082100.44
3837715836878837296100.95
481881281889381885298.73
582681882644682663299.67
6836000836789836394100.84
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12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%
111.817402787401897390017380857369887389080.20
211.837390697418437404560.27
单位质量响应值RSD%判断
62566.3062591.380.03数据可信
影响因素10天-供试品溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024072521180260080232680246396.7994.144.0090.19%~98.09%
278319378135178227294.35
380220580265480243096.78
480943781150281047097.75
575099475135275117390.60
673437873405573421688.56
2024073021182011081859181935098.8398.823.0895.63%~102.01%
277586077590177588093.58
381461681461781461698.25
4831967831641831804100.33
5853991850908852450102.82
682205582142082173899.11
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