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%
117.572381832383592381842376572372192379200.20
217.522374412374812374610.02
单位质量响应值RSD%判断
13541.2613553.710.07数据可信
长期30℃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
2024051611批1272366272524272445101.83101.032.2298.68%～103.37%
2276779275991276385103.30
325964125908925936596.94
4267932268246268089100.20
5272133272433272283101.77
6273362273155273258102.13
2024051612批1270534271417270976101.28100.591.4399.08%～102.10%
226382726362426372698.57
3269692269651269672100.79
426667626694426681099.72
5268583268501268542100.37
6275050275080275065102.81
2024051613批126012925938625975897.09100.261.9598.21%～102.30%
2271840271586271713101.55
326327026413126370098.56
4271481271468271474101.47
5270774270649270712101.18
6271555272563272059101.68
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%
117.574744464749364745484746874749884747210.05
217.524743244743464743350.01
单位质量响应值RSD%判断
27018.8427073.920.15数据可信
长期30℃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
2024051611批153265153312853289099.76100.331.1599.12%～101.54%
2543027543587543307101.71
3539580539882539731101.05
453171453111253141399.49
5540119540861540490101.19
652792652727852760298.77
2024051612批152805552870452838098.9298.970.2598.72%～99.22%
252917852937252927599.09
352885952900352893199.02
452699852662552681298.63
552785652782852784298.82
653090853036953063899.34
2024051613批152735252835452785398.8298.521.7996.68%～100.37%
252747952714352731198.72
353336153299853318099.82
451087251113751100495.67
552080652057252068997.48
6537899537232537566100.64
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%
117.579516589503249508989506039501259507220.07
217.529547459543529545480.03
单位质量响应值RSD%判断
54110.5354483.330.49数据可信
长期30℃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
2024051611批110684811069262106887299.6898.461.1797.26%～99.66%
210405691040023104029697.01
310646421064456106454999.28
410536821052761105322298.22
510421441043454104279997.25
610650211065331106517699.33
2024051612批110659691065653106581199.3999.750.8798.85%～100.65%
2107669210758281076260100.37
310681631068300106823299.62
4107916610772501078208100.55
510538311053506105366898.26
6107477010763131075542100.30
2024051613批110700211070115107006899.7999.971.1898.74%～101.20%
210621681062229106219899.06
3109382010909721092396101.87
410702321069968107010099.79
510572161057853105753498.62
6107946210801841079823100.70
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