伐地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
111.943761903721163741843782153745023750410.62
211.913807503787453797480.38
单位质量响应值RSD%判断
31410.4731884.801.06数据可信
长期18月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121140216940674840445896.8798.242.5295.64%～100.83%
241253341600841427099.22
339011639443739227693.96
4418273417766418020100.12
541354540976641165698.60
6418799421646420222100.65
2024030221140983941249741116898.4898.961.6197.29%～100.62%
240502240056840279596.48
341269141468341368799.09
441642341303841473099.34
541539641078441309098.94
6426341420446423394101.41
2024030321140154039821839987995.7898.492.2996.12%～100.85%
240558540323140440896.86
341319940871041095498.43
441012040474140743097.59
5421478427576424527101.68
6417852422121419986100.59
伐地那非片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
111.943793443802103811963812143808513805630.21
211.913778193782513780350.09
单位质量响应值RSD%判断
31872.9531740.970.30数据可信
长期18月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211431553431133431343102.79101.872.3999.32%～104.43%
2428395429514428954102.22
341899441963441931499.92
4444573443435444004105.81
5426888426384426636101.67
641558441376641467598.82
2024030221141453441480541467098.8298.901.4697.40%～100.41%
240688840699040693996.98
341079541054541067097.86
4424173422818423496100.92
5419858420328420093100.11
641320541545041432898.74
20240303211421032420244420638100.2497.842.1195.67%～100.00%
240057540092340074995.50
3420513419384419948100.08
441051841090841071397.88
540201140036240118695.60
641026740986241006497.72
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