盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.077603197605887601197601747602247602850.03
2 12.147609307609707609500.01
单位质量响应值RSD%判断
62989.6462681.220.35数据可信
供试品溶液-BXK1KP1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1784268-78426894.20892.854.5394.2192.854.53
2828103-82810399.47499.47
3786910-78691094.52694.53
4728673-72867387.53087.53
5763771-76377191.74691.75
6746105-74610589.62489.62
10min1824439-82443999.03497.992.6899.1998.152.68
2848615-848615101.938102.10
3829400-82940099.63099.79
4798185-79818595.88096.03
5793815-79381595.35595.51
6800192-80019296.12196.27
15min1833103-833103100.07599.252.31100.4099.572.31
2853672-853672102.545102.88
3837541-837541100.608100.93
4821348-82134898.66298.97
5801377-80137796.26396.58
6810487-81048797.35897.67
20min1834171-834171100.20399.692.22100.69100.182.22
2855155-855155102.723103.23
3840450-840450100.957101.45
4831553-83155399.888100.36
5804117-80411796.59397.06
6814148-81414897.79898.27
30min1833355-833355100.105100.241.96100.76100.891.96
2854708-854708102.670103.35
3842677-842677101.225101.88
4841631-841631101.099101.74
5807101-80710196.95197.58
6827288-82728899.376100.01
45min1834454-834454100.237100.372.13101.06101.182.13
2854349-854349102.627103.48
3844771-844771101.476102.30
4849730-849730102.072102.88
5808481-80848197.11797.91
6821445-82144598.67499.47
60min1832551-832551100.008100.302.12101.00101.282.12
2852220-852220102.371103.39
3843749-843749101.353102.35
4851762-851762102.316103.29
5808377-80837797.10498.06
6821323-82132398.65999.62
90min1830583-83058399.772100.402.27100.93101.552.26
2850437-850437102.157103.35
3850273-850273102.137103.30
4854399-854399102.633103.78
5807922-80792297.05098.17
6821216-82121698.64799.78
120min1-0.0000.00-1.321.322.28
2-0.0001.36
3-0.0001.34
4-0.0001.32
5-0.0001.28
6-0.0001.29
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.321.322.28
2-0.0001.36
3-0.0001.34
4-0.0001.32
5-0.0001.28
6-0.0001.29
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.077590977590127592077586657589657589890.03
2 12.147594567593187593870.02
单位质量响应值RSD%判断
62882.2762552.470.38数据可信
供试品溶液-BXK1KP1批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1739302-73930288.97490.963.4988.9790.963.49
2787754-78775494.80594.81
3733905-73390588.32588.32
4765279-76527992.10092.10
5726065-72606587.38187.38
6782653-78265394.19194.19
10min1794700-79470095.64198.182.0295.7998.332.02
2837989-837989100.851101.01
3817976-81797698.44298.59
4820448-82044898.74098.89
5798497-79849796.09896.24
6825021-82502199.29099.45
15min1800329-80032996.31999.082.2696.6399.392.26
2847031-847031101.939102.27
3817161-81716198.34498.66
4834027-834027100.374100.69
5805282-80528296.91597.22
6835611-835611100.565100.89
20min1806107-80610797.01499.432.1897.4899.912.18
2849222-849222102.203102.70
3823053-82305399.05399.53
4837414-837414100.782101.27
5805160-80516096.90097.37
6835957-835957100.606101.10
30min1806244-80624497.03199.452.1697.66100.102.16
2849499-849499102.236102.90
3823592-82359299.11899.76
4840617-840617101.167101.82
5806239-80623997.03097.66
6831881-831881100.116100.77
45min1809804-80980497.45999.641.8098.25100.451.80
2843750-843750101.544102.38
3821091-82109198.81799.62
4841646-841646101.291102.11
5813804-81380497.94098.73
6837563-837563100.800101.62
60min1810761-81076197.57499.911.9998.53100.891.99
2847292-847292101.971102.98
3832311-832311100.168101.14
4844740-844740101.663102.65
5809359-80935997.40598.36
6836770-836770100.704101.70
90min1819670-81967098.646100.031.5899.76101.171.58
2850013-850013102.298103.47
3819731-81973198.65499.79
4841500-841500101.274102.43
5820505-82050598.74799.86
6835393-835393100.539101.70
120min1-0.0000.00-1.281.312.24
2-0.0001.35
3-0.0001.30
4-0.0001.33
5-0.0001.28
6-0.0001.33
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.281.312.24
2-0.0001.35
3-0.0001.30
4-0.0001.33
5-0.0001.28
6-0.0001.33
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.077605797602457598387598917592147599530.07
2 12.147620757615917618330.05
单位质量响应值RSD%判断
62962.1462753.950.24数据可信
供试品溶液-BXK1KP1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%
5min1190729-19072922.90323.065.8822.9023.065.89
2183405-18340522.02322.02
3178426-17842621.42521.43
4198808-19880823.87323.87
5210161-21016125.23625.24
6190828-19082822.91422.91
10min1302103-30210336.27635.833.6036.3135.873.60
2287183-28718334.48534.52
3285251-28525134.25334.29
4314200-31420037.72937.77
5301411-30141136.19336.24
6300055-30005536.03036.07
15min1376693-37669345.23343.982.8645.3344.082.86
2352451-35245142.32242.42
3358565-35856543.05643.15
4379081-37908145.52045.62
5361962-36196243.46443.57
6368575-36857544.25844.36
20min1430653-43065351.71250.182.6251.8950.362.62
2402421-40242148.32248.49
3415340-41534049.87450.04
4428241-42824151.42351.60
5409615-40961549.18649.36
6421301-42130150.58950.76
30min1502178-50217860.30158.182.6560.5658.432.65
2468714-46871456.28356.53
3487168-48716858.49958.75
4491761-49176159.05059.31
5470466-47046656.49356.75
6486641-48664158.43558.69
45min1566399-56639968.01365.552.4968.3765.902.48
2531694-53169463.84564.18
3550154-55015466.06266.41
4546766-54676665.65566.02
5529855-52985563.62463.98
6550329-55032966.08366.44
60min1609298-60929873.16470.472.1973.6470.932.19
2574264-57426468.95769.40
3589067-58906770.73571.19
4584795-58479570.22270.69
5574705-57470569.01069.47
6589059-58905970.73471.20
90min1665766-66576679.94576.822.2680.5477.402.26
2626575-62657575.23875.80
3634147-63414776.14876.72
4636097-63609776.38276.97
5629530-62953075.59376.17
6646417-64641777.62178.20
120min1695649-69564983.53380.791.8184.2681.491.81
2666789-66678980.06780.75
3664724-66472479.81980.52
4665104-66510479.86580.58
5666916-66691680.08380.78
6677586-67758681.36482.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1741598-74159889.05086.481.9389.9287.321.93
2719290-71929086.37287.19
3702385-70238584.34285.17
4725664-72566487.13787.99
5708186-70818685.03885.87
6724065-72406586.94587.79
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