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125
标示量(mg)100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%
117.69328529323849312049319519323999321580.07
217.639310909315079312980.04
单位质量响应值RSD%判断
52963.5252824.620.19数据可信
供试品溶液-2024051611批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1651127-65112762.33160.753.5962.3360.753.59
2643578-64357861.60961.61
3597174-59717457.16757.17
4651398-65139862.35762.36
5648500-64850062.08062.08
6615712-61571258.94158.94
10min1661673-66167363.34161.661.7863.4461.761.78
2646707-64670761.90862.01
3631205-63120560.42460.52
4652027-65202762.41862.52
5636873-63687360.96761.07
6636350-63635060.91761.02
15min1678707-67870764.97262.362.8865.1862.562.87
2635026-63502660.79061.00
3628775-62877560.19260.39
4653694-65369462.57762.79
5646881-64688161.92562.13
6665478-66547863.70563.90
20min1674648-67464864.58362.122.8164.9062.422.80
2636741-63674160.95461.26
3621292-62129259.47559.77
4652926-65292662.50462.82
5651040-65104062.32362.63
6656557-65655762.85163.16
30min1661305-66130563.30660.153.3463.7360.563.33
2623807-62380759.71660.12
3612837-61283758.66659.06
4607735-60773558.17858.59
5617990-61799059.15959.57
6646083-64608361.84962.26
45min1641119-64111961.37359.182.4661.9059.702.46
2616946-61694659.05959.57
3599177-59917757.35857.85
4620862-62086259.43459.95
5604621-60462157.87958.39
6626708-62670859.99460.51
极限1592406-59240656.71054.992.3857.3455.602.37
2562643-56264353.86154.47
3554676-55467653.09853.69
4577866-57786655.31855.93
5577173-57717355.25255.86
6582092-58209255.72356.34
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125
标示量(mg)100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%
117.69327969330329315019314079315059320480.09
217.639296599323869310220.21
单位质量响应值RSD%判断
52957.2752808.960.20数据可信
供试品溶液-t4批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1616970-61697059.07457.713.4459.0757.723.44
2611997-61199758.59858.60
3562185-56218553.82853.83
4601425-60142557.58557.59
5607843-60784358.20058.20
6616197-61619759.00059.00
10min1615493-61549358.93257.233.5359.0357.323.54
2609543-60954358.36358.46
3557865-55786553.41553.50
4602318-60231857.67157.77
5608874-60887458.29958.40
6591933-59193356.67756.77
15min1615659-61565958.94857.853.4759.1558.043.47
2613189-61318958.71258.91
3563638-56363853.96754.15
4599606-59960657.41157.60
5619008-61900859.26959.46
6613896-61389658.78058.97
20min1606696-60669658.09057.313.1158.3957.603.11
2603496-60349657.78458.08
3562484-56248453.85754.13
4596137-59613757.07957.37
5613648-61364858.75659.05
6608540-60854058.26758.56
30min1592220-59222056.70456.262.9557.1056.652.94
2593781-59378156.85457.24
3554885-55488553.12953.49
4583770-58377055.89556.28
5602963-60296357.73358.12
6598173-59817357.27457.66
45min1582065-58206555.73255.242.8056.2255.722.80
2580929-58092955.62356.11
3545792-54579252.25952.71
4575588-57558855.11255.59
5590758-59075856.56457.05
6586653-58665356.17156.65
极限1547394-54739452.41251.742.3852.9952.302.39
2545594-54559452.24052.82
3515490-51549049.35749.89
4537265-53726551.44252.01
5547968-54796852.46753.05
6548269-54826952.49653.07
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125
标示量(mg)100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%
117.69326539339929320829302579325529323070.15
217.639321119322759321930.02
单位质量响应值RSD%判断
52971.9952875.380.13数据可信
供试品溶液-2024051612批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1610420-61042058.40254.814.5858.4054.814.58
2594996-59499656.92656.93
3557384-55738453.32853.33
4573005-57300554.82254.82
5538191-53819151.49151.49
6563074-56307453.87253.87
10min1591008-59100856.54553.815.4856.6453.905.48
2591600-59160056.60156.70
3562739-56273953.84053.93
4557425-55742553.33253.42
5507219-50721948.52848.61
6564700-56470054.02854.12
15min1597367-59736757.15354.444.3957.3454.624.39
2594186-59418656.84957.04
3561241-56124153.69753.88
4568321-56832154.37454.55
5529106-52910650.62250.79
6563899-56389953.95154.13
20min1594098-59409856.84054.044.6257.1354.314.61
2592173-59217356.65656.94
3558848-55884853.46853.74
4555597-55559753.15753.43
5524014-52401450.13550.39
6563972-56397253.95854.23
30min1592085-59208556.64853.294.8657.0353.654.86
2585698-58569856.03756.41
3552199-55219952.83253.19
4550986-55098652.71553.07
5522445-52244549.98550.32
6538260-53826051.49851.86
45min1567129-56712954.26052.333.9854.7452.783.99
2574893-57489355.00355.47
3540244-54024451.68852.13
4543230-54323051.97352.42
5513725-51372549.15149.57
6542636-54263651.91752.36
极限1532487-53248750.94648.654.6151.5149.194.61
2537645-53764551.43952.00
3509382-50938248.73549.27
4505782-50578248.39148.92
5481333-48133346.05146.55
6484527-48452746.35746.89
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