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)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%
112.117639487639907638547636597640027638910.02
212.147627457627317627380.01
单位质量响应值RSD%判断
63079.3662828.500.29数据可信
供试品溶液-2024072721批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1767044-76704492.35392.701.7992.3592.701.79
2794598-79459895.67195.67
3772105-77210592.96392.96
4757470-75747091.20191.20
5771225-77122592.85792.86
6757166-75716691.16491.16
10min1803997-80399796.80397.822.3196.9697.982.31
2845733-845733101.828101.99
3814740-81474098.09698.25
4798561-79856196.14896.30
5817982-81798298.48798.64
6793731-79373195.56795.72
15min1807733-80773397.25398.732.2797.5799.052.27
2852929-852929102.694103.02
3817861-81786198.47298.79
4799222-79922296.22896.54
5826368-82636899.49699.82
6815966-81596698.24498.56
20min1805853-80585397.02699.122.3197.5099.602.31
2848839-848839102.202102.70
3816857-81685798.35198.83
4811590-81159097.71798.19
5845698-845698101.824102.31
6810561-81056197.59398.07
30min1807324-80732497.20399.632.0797.84100.282.07
2855526-855526103.007103.68
3833233-833233100.323100.97
4818656-81865698.56899.20
5833521-833521100.357101.01
6816778-81677898.34298.98
45min1772393-77239392.99898.633.8993.8099.443.87
2851355-851355102.505103.35
3828957-82895799.808100.62
4790307-79030795.15495.95
5849105-849105102.234103.06
6822827-82282799.07099.87
60min1813271-81327197.91999.441.9298.88100.421.92
2852244-852244102.612103.62
3830959-830959100.049101.03
4810999-81099997.64698.60
5832425-832425100.225101.22
6815734-81573498.21699.18
极限1810591-81059197.59799.632.9698.72100.772.95
2863850-863850104.009105.19
3828695-82869599.776100.92
4793378-79337895.52496.65
5842319-842319101.417102.58
6825980-82598099.449100.58
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)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%
112.117644667643447643037640417646657643640.03
212.147639747638947639340.01
单位质量响应值RSD%判断
63118.4162927.020.22数据可信
供试品溶液-2024072721批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1751645-75164590.40089.771.5890.4089.771.58
2755376-75537690.84990.85
3751135-75113590.33990.34
4733972-73397288.27588.27
5756963-75696391.04091.04
6729307-72930787.71487.71
10min1785944-78594494.52695.671.5394.6895.821.53
2791768-79176895.22695.38
3780516-78051693.87394.02
4796618-79661895.80995.96
5804667-80466796.77796.93
6813392-81339297.82797.97
15min1798089-79808995.98696.981.6596.2997.291.65
2796854-79685495.83896.15
3796200-79620095.75996.07
4801763-80176396.42896.74
5816981-81698198.25898.57
6828405-82840599.63299.94
20min1786285-78628594.56797.302.4295.0397.772.42
2789518-78951894.95595.43
3802241-80224196.48696.95
4816435-81643598.19398.66
5824556-82455699.17099.65
6834979-834979100.423100.90
30min1805935-80593596.93096.791.7897.5697.421.77
2808285-80828597.21397.84
3776912-77691293.43994.07
4809490-80949097.35897.99
5818251-81825198.41199.05
6809700-80970097.38398.03
45min1800048-80004896.22297.512.2697.0198.302.26
2802171-80217196.47797.27
3786701-78670194.61795.40
4819191-81919198.52499.32
5817426-81742698.31299.12
6838966-838966100.903101.71
60min1793461-79346195.43097.611.7696.3898.561.75
2808698-80869897.26298.21
3800416-80041696.26697.21
4814279-81427997.93398.89
5818681-81868198.46399.43
6833881-833881100.291101.26
极限1801990-80199096.45597.951.9397.5699.071.93
2803475-80347596.63497.75
3796667-79666795.81596.92
4824692-82469299.186100.31
5824015-82401599.104100.24
6835570-835570100.494101.63
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)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%
112.117660327657117649697650887649407653480.07
212.147644057638297641170.06
单位质量响应值RSD%判断
63199.6762942.090.29数据可信
供试品溶液-2024072921批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1781201-78120193.88489.745.6993.8889.745.69
2719778-71977886.50286.50
3674531-67453181.06481.06
4760663-76066391.41591.42
5786230-78623094.48894.49
6757839-75783991.07691.08
10min1808523-80852397.16794.742.6797.3294.892.68
2777757-77775793.47093.61
3753541-75354190.55990.69
4786993-78699394.58094.73
5809582-80958297.29497.45
6793602-79360295.37495.53
15min1799313-79931396.06095.472.3196.3895.772.32
2786075-78607594.46994.77
3764219-76421991.84392.13
4797548-79754895.84896.16
5819736-81973698.51598.83
6799316-79931696.06196.37
20min1805798-80579896.84096.082.0897.3296.552.09
2789879-78987994.92795.38
3776066-77606693.26793.71
4802964-80296496.49996.97
5825476-82547699.20599.69
6796766-79676695.75496.23
30min1811221-81122197.49196.431.1198.1397.061.11
2798035-79803595.90796.52
3797355-79735595.82596.42
4798549-79854995.96896.60
5815601-81560198.01898.67
6793480-79348095.35995.99
45min1812197-81219797.60996.591.6898.4197.371.68
2799911-79991196.13296.91
3792736-79273695.27096.02
4798547-79854795.96896.76
5826873-82687399.372100.18
6791880-79188095.16795.96
60min1802528-80252896.44795.062.3597.4196.012.31
2789420-78942094.87195.81
3801900-80190096.37197.28
4800472-80047296.20097.15
5754422-75442290.66591.64
6797343-79734395.82496.77
极限1804261-80426196.65596.721.5197.7897.821.50
2806603-80660396.93698.03
3811682-81168297.54798.62
4788166-78816694.72195.83
5822676-82267698.868100.00
6795272-79527295.57596.68
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)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%
112.117650537650287650017648857658117651560.05
212.147653857652527653180.02
单位质量响应值RSD%判断
63183.8263041.020.16数据可信
供试品溶液-2024072921批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1764413-76441391.80587.496.7591.8187.496.75
2780292-78029293.71293.71
3653283-65328378.45978.46
4685205-68520582.29382.29
5750449-75044990.12890.13
6737419-73741988.56388.56
10min1795375-79537595.52493.474.0795.6893.614.08
2813262-81326297.67297.83
3725083-72508387.08287.21
4757770-75777091.00891.14
5791963-79196395.11495.26
6786152-78615294.41694.56
15min1809043-80904397.16595.093.8897.4895.393.88
2819339-81933998.40298.72
3744774-74477489.44789.72
4761638-76163891.47291.76
5805867-80586796.78497.09
6809677-80967797.24297.55
20min1814213-81421397.78695.362.8998.2695.822.89
2810835-81083597.38197.86
3755737-75573790.76391.19
4778039-77803993.44293.88
5807951-80795197.03497.50
6797299-79729995.75596.22
30min1810608-81060897.35395.642.5597.9996.262.56
2814504-81450497.82198.47
3761960-76196091.51192.09
4782723-78272394.00494.60
5800622-80062296.15496.79
6807803-80780397.01697.64
45min1812312-81231297.55896.212.9198.3696.982.92
2823715-82371598.92799.74
3759037-75903791.16091.89
4790144-79014494.89695.65
5808848-80884897.14297.93
6812285-81228597.55598.34
60min1814694-81469497.84496.182.2398.8197.122.25
2816002-81600298.00198.97
3772279-77227992.75093.63
4786017-78601794.40095.31
5803909-80390996.54997.50
6812133-81213397.53698.49
极限1819566-81956698.42997.121.9499.5598.221.95
2826369-82636999.246100.38
3784292-78429294.19395.23
4797746-79774695.80996.88
5806869-80686996.90498.02
6817095-81709598.13299.25
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