枸橼酸西地那非口崩片项目信息
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%
113.914734144736484739334735814734814736110.05
213.914729254729434729340.01
单位质量响应值RSD%判断
34048.2433999.570.11数据可信
加速3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
20240301211546197546252546224101.61100.910.44100.45%~101.37%
2541973541793541883100.80
3542205542163542184100.86
4542075542462542268100.88
5539013538804538908100.25
6543437543065543251101.06
20240302211537890537845537868100.06100.120.4499.65%~100.58%
2541354541973541664100.76
353658053638953648499.80
453723453725253724399.94
553559553537753548699.61
6540527540221540374100.52
2024030321153621953588653605299.72100.380.8999.45%~101.32%
2538497538428538462100.17
3540922540920540921100.63
453299753343053321499.19
5542856542198542527100.92
6546591546572546582101.68
枸橼酸西地那非口崩片项目信息
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%
113.914724254720844720874718814717524720460.06
213.914730114730024730060.01
单位质量响应值RSD%判断
33935.7334004.740.15数据可信
加速3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
20240301211537565537233537399100.13100.660.8799.75%~101.57%
2544231544131544181101.39
353571353575653573499.82
4539554539660539607100.54
5547550547578547564102.02
6536846536972536909100.04
2024030221153444053419653431899.55100.740.70100.01%~101.47%
2543799543853543826101.33
3540966540921540944100.79
4540149540057540103100.63
5539797540213540005100.61
6544864545008544936101.53
2024030321152177652183352180497.2299.151.2597.86%~100.44%
252851952855452853698.48
353411753415753413799.52
453034053082053058098.86
5537950538179538064100.25
6540013539340539676100.55
枸橼酸西地那非口崩片项目信息
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%
113.914737344736184732724734044730954734250.06
213.914745364745364745360.00
单位质量响应值RSD%判断
34034.8734114.740.17数据可信
加速3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
20240301211543343543861543602100.97100.690.55100.12%~101.26%
2542713543454543084100.88
3546147546414546280101.47
4539355539370539362100.19
553821453824553823099.98
6541820541717541768100.63
20240302211539252538887539070100.13100.000.7799.19%~100.81%
2541533541966541750100.63
353673553693153683399.72
453091053092553091898.62
5538943539483539213100.16
6542129542500542314100.73
20240303211545487545853545670101.36101.211.5199.60%~102.81%
2542821543013542917100.85
3554521554061554291102.96
4541041540567540804100.45
5553299553134553216102.76
653256253202753229498.87
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