枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.824672474717704766944717164706824716220.72
213.884693084697304695190.07
单位质量响应值RSD%判断
34126.0533827.020.63数据可信
加速6月-供试品溶液-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211553504553010553257103.07100.811.5399.20%~102.42%
2544830541364543097101.17
353251553231753241699.18
4542068537941540004100.60
553196153183053189699.09
6548648543731546190101.75
20240302211537360537162537261100.09101.070.78100.24%~101.90%
2549686550419550052102.47
3536304547124541714100.92
4546696538368542532101.07
5543761542364543062101.17
6541024540122540573100.70
20240303211542515544312543414101.23100.201.4398.70%~101.70%
252626352712152669298.12
353289353235353262399.22
4544894544161544528101.44
553429953489253459699.59
6545202545531545366101.60
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.824662844675644674754679884677984674220.15
213.884684034677474680750.10
单位质量响应值RSD%判断
33822.1433722.980.21数据可信
加速6月-供试品溶液-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211540935539877540406101.28101.770.97100.74%~102.79%
2544165543220543692101.89
3544096544516544306102.01
4551531550621551076103.28
5537996532286535141100.29
6542454544468543461101.85
20240302211548767548668548718102.84102.910.32102.57%~103.25%
2550314549148549731103.03
3550134550711550422103.15
4549055548243548649102.82
5551783550303551043103.27
6546413545952546182102.36
20240303211548750545581547166102.54102.160.65101.46%~102.85%
2544001542586543294101.82
3542486540277541382101.46
4546522546409546466102.41
5541931541676541804101.54
6549891550990550440103.16
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数200
标示量(mg)50供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.824693314651934656274667124664044666530.35
213.884691044682094686560.14
单位质量响应值RSD%判断
33766.5033764.840.01数据可信
加速6月-供试品溶液-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211543034540623541828101.56101.120.83100.25%~102.00%
2535553534954535254100.33
3535898533206534552100.20
4537282537994537638100.78
5546223546074546148102.37
6543366539483541424101.49
20240302211547767547711547739102.67101.620.90100.67%~102.57%
2542778537599540188101.26
3539811537228538520100.94
4536442536743536592100.58
5542008540900541454101.49
6548233548259548246102.77
2024030321152975152977552976399.30101.361.16100.14%~102.59%
2544051543672543862101.95
3545084539899542492101.69
4545885546265546075102.36
5537478536884537181100.69
6548055542356545206102.20
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