枸橼酸西地那非片项目信息
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125
标示量(mg)100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%
116.922306462305732304252307912309552306780.09
216.922258822262502260660.12
单位质量响应值RSD%判断
13633.4513360.871.43数据可信
长期9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
2024030121126500326399826450099.2498.122.1195.94%~100.29%
225828725832725830796.91
325901125855625878497.09
4271783270930271356101.81
525647525667225657496.26
625958725953925956397.38
2024030221126377126390926384098.9998.541.9096.58%~100.51%
226588226564726576499.71
325698625653925676296.33
425669625649525659696.27
526399426413926406699.07
6268695269176268936100.90
2024030321126575526628926602299.8199.111.6597.39%~100.83%
2269907270240270074101.33
325684325687325685896.37
426314226338226326298.77
526352726315026333898.80
626521426559226540399.58
枸橼酸西地那非片项目信息
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125
标示量(mg)100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%
116.924400714401144388424406944401424399730.16
216.924414944414694414820.01
单位质量响应值RSD%判断
26003.1326092.320.25数据可信
长期9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
20240301211534549534964534756103.95102.620.97101.58%~103.66%
2524584525625525104102.08
3533664533316533490103.71
4522246521741521994101.47
5525137525029525083102.07
6527325526655526990102.44
2024030221150795950751250773698.7099.781.5598.17%~101.40%
2517452518676518064100.71
3518313517021517667100.63
4523315522631522973101.66
551165451271151218299.56
650131450116350123897.44
20240303211524035523696523866101.84101.621.5499.98%~103.25%
2523094523750523422101.75
3541670525983533826103.77
4523693522875523284101.72
550851250905950878698.90
6523104523319523212101.71
枸橼酸西地那非片项目信息
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125
标示量(mg)100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%
116.928972428965068969578973898963968968980.05
216.928984108984598984340.01
单位质量响应值RSD%判断
53008.1653098.940.13数据可信
长期9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
20240301211105045510510571050756100.28100.311.4398.81%~101.81%
2106193910606901061314101.29
310298981029117102950898.26
4106304910635571063303101.48
5106560410643901064997101.64
610365641036578103657198.93
20240302211105544110538711054656100.66101.350.98100.31%~102.38%
2105817710589051058541101.03
3106219310622661062230101.38
4108217910819561082068103.27
5105392010544731054196100.61
6105967210594481059560101.13
2024030321110271751028571102787398.1099.821.6498.10%~101.53%
210320701033178103262498.55
3104932410505621049943100.21
410416441042115104188099.44
5107559810772391076418102.73
610473221045792104655799.88
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