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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
111.973860383857103862683858093858343859320.06
211.993858823857593858200.03
单位质量响应值RSD%判断
32241.6032178.480.14数据可信
供试品溶液-2024072521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%
5min1196988-19698892.71191.112.5092.7191.112.50
2192711-19271190.69890.70
3190408-19040889.61589.61
4196307-19630792.39192.39
5199053-19905393.68393.68
6186049-18604987.56387.56
10min1225043-225043105.91599.183.96106.0799.343.96
2214674-214674101.035101.19
3200398-20039894.31694.47
4207964-20796497.87798.03
5208496-20849698.12898.28
6207855-20785597.82697.97
15min1212021-21202199.78797.522.20100.1297.842.20
2208922-20892298.32898.65
3199683-19968393.98094.29
4203920-20392095.97496.29
5209856-20985698.76899.09
6208817-20881798.27998.59
20min1210241-21024198.94997.411.6699.4597.891.66
2208159-20815997.96998.45
3200356-20035694.29794.76
4207294-20729497.56298.04
5208476-20847698.11898.60
6207347-20734797.58798.06
30min1212491-212491100.00897.602.28100.6798.242.28
2210260-21026098.95899.60
3198712-19871293.52394.14
4208234-20823498.00498.64
5207898-20789897.84698.49
6206626-20662697.24797.88
45min1212801-212801100.15499.021.27100.9899.821.26
2210525-21052599.08299.89
3214101-214101100.766101.54
4208245-20824598.00998.81
5209495-20949598.59899.41
6207149-20714997.49498.29
60min1212804-212804100.15597.342.38101.1598.312.37
2208970-20897098.35199.33
3198407-19840793.37994.32
4204971-20497196.46997.43
5209252-20925298.48399.46
6206591-20659197.23198.19
90min1229132-229132107.84098.864.83109.0099.994.79
2210378-21037899.013100.15
3198808-19880893.56894.67
4207211-20721197.52398.65
5206746-20674697.30498.44
6207998-20799897.89399.02
120min1-0.0000.00-1.341.302.04
2-0.0001.31
3-0.0001.26
4-0.0001.29
5-0.0001.30
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1-0.0000.00-1.341.302.04
2-0.0001.31
3-0.0001.26
4-0.0001.29
5-0.0001.30
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
111.973858473858343859553860053861753859630.04
211.993857183852053854620.10
单位质量响应值RSD%判断
32244.1932148.620.21数据可信
供试品溶液-2024072521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%
5min1191849-19184990.33190.982.9090.3390.982.91
2185006-18500687.10987.11
3201037-20103794.65794.66
4189833-18983389.38289.38
5195075-19507591.85091.85
6196621-19662192.57892.58
10min1199533-19953393.94998.705.9594.1098.855.95
2202457-20245795.32695.47
3209588-20958898.68398.84
4208840-20884098.33198.48
5203478-20347895.80795.96
6233835-233835110.100110.25
15min1201208-20120894.73898.724.5595.0499.044.54
2204210-20421096.15196.46
3211204-21120499.44499.77
4227933-227933107.321107.63
5206838-20683897.38997.70
6206625-20662597.28897.63
20min1200223-20022394.27497.794.0194.7498.274.00
2204342-20434296.21396.68
3208046-20804697.95798.45
4210732-21073299.22299.71
5200402-20040294.35894.83
6222408-222408104.720105.22
30min1200831-20083194.56096.692.0095.1897.342.00
2203668-20366895.89696.52
3209424-20942498.60699.26
4208199-20819998.02998.69
5200815-20081594.55395.19
6209228-20922898.51499.19
45min1197983-19798393.21996.822.7194.0097.632.70
2208906-20890698.36299.15
3208577-20857798.20799.02
4211547-21154799.606100.43
5199422-19942293.89794.69
6207405-20740597.65698.49
60min1199438-19943893.90496.062.2294.8497.022.23
2203612-20361295.87096.82
3205906-20590696.95097.93
4207950-20795097.91298.90
5198006-19800693.23094.18
6209134-20913498.47099.47
90min1191462-19146290.14995.163.2991.2496.293.27
2201968-20196895.09696.20
3204882-20488296.46897.61
4211086-21108699.389100.54
5198642-19864293.53094.63
6204616-20461696.34297.51
120min1-0.0000.00-1.241.292.77
2-0.0001.27
3-0.0001.30
4-0.0001.32
5-0.0001.26
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1-0.0000.00-1.241.292.77
2-0.0001.27
3-0.0001.30
4-0.0001.32
5-0.0001.26
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
111.973866383866023855063846233846613856060.26
211.993874733872983873860.04
单位质量响应值RSD%判断
32214.3732309.090.21数据可信
供试品溶液-2024072621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%
5min1116059-11605954.53553.219.2654.5453.219.26
293191-9319143.79043.79
3120182-12018256.47256.47
4110880-11088052.10252.10
5117836-11783655.37055.37
6121298-12129856.99757.00
10min1158376-15837674.42068.518.1274.5168.608.12
2124383-12438358.44658.52
3153383-15338372.07372.17
4142308-14230866.86966.96
5147318-14731869.22369.32
6149093-14909370.05870.15
15min1162903-16290376.54774.335.2476.7674.535.25
2142333-14233366.88167.05
3165140-16514077.59877.81
4156442-15644273.51173.71
5161781-16178176.01976.23
6160488-16048875.41275.62
20min1171148-17114880.42178.165.1380.7678.485.13
2149760-14976070.37170.65
3172487-17248781.05081.39
4165142-16514277.59977.92
5170867-17086780.28980.62
6168605-16860579.22679.56
30min1182311-18231185.66684.354.4686.1484.814.47
2164574-16457477.33277.73
3186968-18696887.85588.33
4177778-17777883.53683.99
5184920-18492086.89287.36
6180540-18054084.83485.30
45min1192024-19202490.23089.213.9490.8589.803.95
2176915-17691583.13183.66
3198987-19898793.50294.13
4188361-18836188.50989.10
5194206-19420691.25691.87
6188567-18856788.60689.22
60min1196557-19655792.36091.743.2393.1392.493.25
2184131-18413186.52287.19
3201837-20183794.84195.62
4193836-19383691.08291.82
5200482-20048294.20594.97
6194632-19463291.45692.21
90min1201701-20170194.77895.325.4195.7096.225.39
2191552-19155290.00990.82
3206250-20625096.91597.85
4197777-19777792.93493.82
5222862-222862104.721105.64
6196949-19694992.54593.46
120min1202626-20262695.21294.292.7096.2995.352.72
2192674-19267490.53691.50
3207502-20750297.50398.60
4198617-19861793.32894.37
5204984-20498496.32097.42
6197625-19762592.86293.93
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1203637-20363795.68796.585.1296.9397.795.09
2194600-19460091.44192.55
3225112-225112105.778107.04
4203635-20363595.68696.89
5206993-20699397.26498.52
6199209-19920993.60794.83
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
111.973866263866633861793863913862033864120.06
211.993862953863253863100.01
单位质量响应值RSD%判断
32281.7032219.350.14数据可信
供试品溶液-2024072621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%
5min1116714-11671454.86253.986.6254.8653.986.62
2110109-11010951.75751.76
3121289-12128957.01257.01
4104149-10414948.95648.96
5124764-12476458.64658.65
6112007-11200752.64952.65
10min1147265-14726569.22267.522.7569.3167.622.76
2143069-14306967.25067.34
3145433-14543368.36168.46
4138866-13886665.27565.36
5148031-14803169.58369.68
6139252-13925265.45665.54
15min1159675-15967575.05672.872.0075.2673.072.00
2153175-15317572.00172.20
3157397-15739773.98574.19
4153677-15367772.23672.43
5155072-15507272.89273.11
6151093-15109371.02271.22
20min1167580-16758078.77277.751.5779.1078.081.56
2161638-16163875.97976.30
3165368-16536877.73278.06
4163906-16390677.04577.36
5165078-16507877.59677.93
6168896-16889679.39079.71
30min1179336-17933684.29882.262.1784.7682.712.17
2172250-17225080.96781.41
3176390-17639082.91383.37
4177920-17792083.63284.07
5175040-17504082.27882.74
6169072-16907279.47379.92
45min1188105-18810588.42087.101.9889.0287.691.97
2182044-18204485.57186.15
3187566-18756688.16688.77
4189626-18962689.13489.71
5184001-18400186.49087.09
6180489-18048984.84085.42
60min1191696-19169690.10789.302.0590.8690.042.04
2186461-18646187.64788.37
3191678-19167890.09990.85
4195846-19584692.05892.79
5188857-18885788.77389.52
6185307-18530787.10487.83
90min1197105-19710592.65091.942.2293.5592.822.20
2192711-19271190.58591.45
3198588-19858893.34794.24
4201769-20176994.84295.72
5193346-19334690.88391.78
6190026-19002689.32290.19
120min1196230-19623092.23992.572.1393.2993.602.12
2194387-19438791.37292.39
3200439-20043994.21795.27
4203310-20331095.56796.61
5195310-19531091.80692.85
6191901-19190190.20491.22
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1197788-19778892.97193.652.9794.1894.842.94
2207107-20710797.35198.52
3201123-20112394.53995.75
4203510-20351095.66196.86
5195098-19509891.70792.90
6190767-19076789.67190.84
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