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500
标示量(mg)25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%
117.312240542252282240082241012256292246040.35
217.322261862277222269540.48
单位质量响应值RSD%判断
12975.3913103.580.70数据可信
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
2024051611批1258451260085259268100.6899.391.7197.61%～101.16%
225530225632325581299.34
324765924850024808096.34
4260667260654260660101.22
525559225551925555699.24
625556725690625623699.50
2024051711批1262765264639263702102.40102.111.27100.76%～103.46%
225690725709725700299.80
3262169260282261226101.44
4264601265679265140102.96
5264478265453264966102.89
6265278266083265680103.17
2024051911批125057225192625124997.5799.951.5698.32%～101.58%
225632125737825685099.74
3259498260975260236101.06
4262252262020262136101.79
525440125476825458498.86
6259858258615259236100.67
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500
标示量(mg)25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%
117.314679024652074666744664214674464667300.23
217.324623774629864626820.10
单位质量响应值RSD%判断
26963.0326713.740.66数据可信
供试品溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024051611批151706851835751771297.6897.760.9696.78%～98.74%
251876552129252002898.11
351989152313752151498.39
450854550829050841895.92
552226651960152093498.28
651980252087652033998.17
2024051711批1534491534223534357100.8298.581.5596.99%～100.17%
251384151529251456697.08
351972952207552090298.28
452663052599752631499.30
550870651719351295096.78
652651252531952591699.22
2024051911批152409752269952339898.7599.181.5997.54%～100.83%
252028452000052014298.13
351525951596051561097.28
452996952956552976799.95
552444852705152575099.19
6539242539821539532101.79
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500
标示量(mg)25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%
117.319220929209059334319296109319199275910.62
217.329259239297589278400.30
单位质量响应值RSD%判断
53587.0053570.440.03数据可信
供试品溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024051611批1110284810995031101176104.07101.611.6399.88%～103.35%
2108667810867831086730102.70
310594091051078105524499.73
4106857710675541068066100.94
5108162710790591080343102.10
6106079210584631059628100.14
2024051711批110542781048450105136499.3699.931.0898.80%～101.06%
2106612410609481063536100.51
3105914410595251059334100.11
410543481053272105381099.59
5107588710739251074906101.58
610410771041924104150098.43
2024051911批110453021044783104504298.76100.051.3198.68%～101.42%
2106651210726831069598101.08
310552521056618105593599.79
410533981054060105372999.58
5108082810805041080666102.13
610469021047530104721698.97
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500
标示量(mg)25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%
117.319242549295959325049329069316009301720.39
217.329249589319069284320.53
单位质量响应值RSD%判断
53736.1153604.620.18数据可信
供试品溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024051611批110358151033757103478697.6399.081.0498.00%～100.16%
210541531054240105419699.46
310407921041534104116398.23
4106615110658721066012100.57
510473991055903105165199.22
610530971053398105324899.37
2024051711批110062581011906100908295.2096.743.5593.14%～100.35%
210420271041693104186098.29
395920195896195908190.48
410576151057967105779199.80
510369501037323103713697.85
610475771047794104768698.84
2024051911批1106652410641781065351100.5198.811.3997.37%～100.24%
210458201044331104507698.60
3106070410600261060365100.04
410506331050136105038499.10
510353541033993103467497.62
610278271027932102788096.97
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