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250
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%
117.184686654684024686784690654689424687500.06
217.064678264679004678630.02
单位质量响应值RSD%判断
27284.6327424.560.37数据可信
供试品溶液-2024041511批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1544673-544673100.82299.191.17100.8299.191.17
2537003-53700399.40299.40
3529638-52963898.03998.04
4530236-53023698.15098.15
5532046-53204698.48598.48
6541503-541503100.235100.24
10min1540078-54007899.97299.740.76100.1499.900.76
2542922-542922100.498100.66
3534131-53413198.87199.03
4537464-53746499.48899.65
5534649-53464998.96799.13
6543688-543688100.640100.81
15min1543705-543705100.64399.920.69100.98100.250.69
2542305-542305100.384100.72
3536619-53661999.33199.66
4538139-53813999.61399.94
5534935-53493599.02099.35
6542990-542990100.511100.85
20min1548007-548007101.439100.300.79101.94100.800.79
2542440-542440100.409100.91
3538115-53811599.608100.10
4542951-542951100.503101.00
5535995-53599599.21699.71
6543686-543686100.639101.14
30min1544429-544429100.77799.660.73101.45100.320.73
2539236-53923699.816100.48
3534279-53427998.89899.56
4538740-53874099.724100.39
5533822-53382298.81499.47
6539711-53971199.904100.57
45min1562151-562151104.057100.161.94104.90100.991.93
2537672-53767299.526100.36
3539045-53904599.780100.60
4536143-53614399.243100.07
5534024-53402498.85199.68
6537476-53747699.490100.33
极限1544451-544451100.78199.550.82101.79100.540.82
2538568-53856899.692100.69
3533272-53327298.71299.70
4539090-53909099.789100.78
5532515-53251598.57299.56
6538846-53884699.744100.75
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250
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%
117.184688504683624685134685094685194685510.04
217.064672804662534667660.16
单位质量响应值RSD%判断
27273.0527360.260.23数据可信
供试品溶液-2024041511批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1531784-53178498.57399.240.5598.5799.230.55
2538179-53817999.75899.76
3535972-53597299.34999.35
4535568-53556899.27499.27
5538639-53863999.84399.84
6532003-53200398.61398.61
10min1532790-53279098.75999.900.7298.92100.060.72
2540989-540989100.279100.45
3538264-53826499.77499.94
4541963-541963100.459100.62
5543048-543048100.661100.83
6536559-53655999.45899.62
15min1535763-53576399.31099.930.5399.64100.260.53
2539934-539934100.083100.42
3538863-53886399.885100.22
4541659-541659100.403100.74
5542407-542407100.542100.88
6535924-53592499.34099.67
20min1531473-53147398.515100.051.2099.01100.551.19
2549942-549942101.938102.44
3537581-53758199.647100.15
4542556-542556100.569101.07
5541549-541549100.383100.88
6535337-53533799.23199.73
30min1533059-53305998.80999.800.8099.47100.460.80
2542212-542212100.506101.18
3537643-53764399.659100.32
4541719-541719100.414101.08
5542132-542132100.491101.16
6533672-53367298.92399.58
45min1530258-53025898.29099.650.9399.11100.480.93
2541723-541723100.415101.25
3536002-53600299.354100.18
4542331-542331100.528101.36
5541433-541433100.361101.20
6533945-53394598.97399.80
极限1532551-53255198.71599.800.8699.70100.800.85
2543680-543680100.778101.78
3536373-53637399.423100.42
4542386-542386100.538101.54
5541086-541086100.297101.30
6534469-53446999.070100.06
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250
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%
117.184717234722854726134725534717434721830.10
217.064674854670584672720.07
单位质量响应值RSD%判断
27484.4627389.920.25数据可信
供试品溶液-2024051711批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1506541-50654193.48191.884.5593.4891.884.55
2504521-50452193.10893.11
3524438-52443896.78496.78
4511045-51104594.31294.31
5474371-47437187.54487.54
6466189-46618986.03486.03
10min1530682-53068297.93695.983.1098.0996.143.11
2526172-52617297.10497.26
3535054-53505498.74398.90
4524002-52400296.70396.86
5514174-51417494.89095.04
6490500-49050090.52190.66
15min1533672-53367298.48897.072.7098.8197.382.70
2536882-53688299.08099.40
3538208-53820899.32599.65
4523909-52390996.68697.00
5523105-52310596.53896.84
6500233-50023392.31792.61
20min1530271-53027197.86097.232.4298.3497.712.42
2539912-53991299.640100.12
3537409-53740999.17899.67
4521960-52196096.32796.81
5526961-52696197.25097.71
6504727-50472793.14693.59
30min1531434-53143498.07598.092.0698.7298.722.06
2546853-546853100.921101.57
3537082-53708299.11799.77
4523899-52389996.68497.32
5534414-53441498.62599.25
6515274-51527495.09395.70
45min1532563-53256398.28398.691.9399.0999.491.93
2551147-551147101.713102.53
3537220-53722099.14399.96
4525962-52596297.06597.87
5539261-53926199.519100.31
6522351-52235196.39997.16
极限1530239-53023997.85499.521.7798.83100.481.75
2556034-556034102.615103.60
3533007-53300798.36599.35
4533500-53350098.45699.42
5543355-543355100.275101.23
6539293-53929399.525100.45
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