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%
117.572386132380492383662386672388732385140.14
217.522389472384792387130.14
单位质量响应值RSD%判断
13575.0713625.170.27数据可信
加速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1271968271761271864101.2298.582.5495.96%～101.20%
226101326044126072797.07
325522625556525539695.09
426521726562126541998.82
5272881272794272838101.58
626242426239426240997.70
2024051612批126801126771026786099.7399.512.4296.99%～102.04%
225566625574025570395.20
326457126522926490098.63
4272740272785272762101.55
5268870269707269288100.26
6273546272838273192101.71
2024051613批1275201274928275064102.41100.071.9198.07%～102.06%
2272285272466272376101.41
3270709271113270911100.86
426087726048226068097.05
526774526617526696099.39
626634926701526668299.29
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%
117.574781284768764773294770144770514772800.11
217.524774284775824775050.03
单位质量响应值RSD%判断
27164.4827254.850.24数据可信
加速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152485452583152534297.7699.322.2297.02%～101.63%
253531753508353520099.60
3554737554866554802103.24
452217052229052223097.18
553771253672453721899.97
652784652754252769498.20
2024051612批152111852142652127297.0098.871.3797.45%～100.29%
2539345540021539683100.43
353426453313853370199.32
453004152979052991698.61
5537863538269538066100.13
652507952518052513097.72
2024051613批153078753046153062498.7499.530.6198.89%～100.17%
253505853451753478899.52
3537695538457538076100.13
4538991539330539160100.33
553403353409653406499.38
653252153241653246899.09
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%
117.579573269573279572239572979578059573960.03
217.529584949586109585520.01
单位质量响应值RSD%判断
54490.3854711.870.29数据可信
加速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1108970710903341090020101.08100.071.3798.63%～101.51%
210656981065217106545898.81
310626841062072106237898.52
410718621072822107234299.44
5110035010993971099874102.00
6108442610843901084408100.56
2024051612批1109789410987021098298101.8599.631.7997.76%～101.50%
2107888710791431079015100.06
310654231066503106596398.85
4108609810856491085874100.70
510751301074896107501399.69
610415081042444104197696.63
2024051613批1108283310848691083851100.5198.691.0497.61%～99.76%
210610761061009106104298.40
310523691051535105195297.55
410565321056889105671097.99
510670471067226106713698.96
610644981064259106437898.71
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