枸橼酸西地那非片项目信息
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%
114.454764854779154772904779444778644775000.14
214.454762634764154763390.03
单位质量响应值RSD%判断
33044.9832964.640.18数据可信
影响因素30天-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
1批1525201526235525718100.82100.300.7299.54%～101.05%
252120252147452133899.98
3529208529510529359101.52
451978251957851968099.66
552128952062052095499.90
652116452081952099299.91
1批1526983527805527394101.14101.500.71100.75%～102.26%
2528011528492528252101.30
3534954535112535033102.60
4532894532724532809102.18
5525471525734525602100.79
6526514526795526654101.00
1批1525768525687525728100.82100.990.52100.45%～101.53%
2525679526045525862100.84
3523472525305524388100.56
4525716527265526490100.97
5532065531839531952102.01
6524872526004525438100.76
枸橼酸西地那非片项目信息
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%
114.454755034746244753414765884763344756780.17
214.454780354767404773880.20
单位质量响应值RSD%判断
32918.8933037.230.26数据可信
影响因素30天-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
1批149087449148549118094.2799.012.4296.50%～101.52%
251826551966451896499.60
3522422522361522392100.26
451817751794851806299.43
5525347526470525908100.94
651809951926651868299.55
1批1522431523540522986100.37101.271.09100.11%～102.42%
2537745537747537746103.21
3522012521639521826100.15
4527058526961527010101.15
5529039530221529630101.65
6526036527226526631101.07
1批149970449986749978695.9299.672.0597.53%～101.81%
252066652113052089899.97
3522318521300521809100.15
451671251665051668199.16
5529990529604529797101.68
6527099526631526865101.12
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