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%
111.807512187516357513347511157509747512550.04
211.797544177535707539940.08
单位质量响应值RSD%判断
63665.6863951.990.32数据可信
中间条件12月-供试品溶液-2024072721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%
5min1793945-79394593.91690.193.6593.9290.193.66
2728834-72883486.21486.21
3787985-78798593.21193.21
4777388-77738891.95791.96
5735017-73501786.94586.95
6751491-75149188.89488.89
10min1830741-83074198.26895.222.4298.4295.372.42
2789745-78974593.41993.56
3822027-82202797.23897.39
4811653-81165396.01096.16
5781994-78199492.50292.65
6793692-79369293.88694.03
15min1836464-83646498.94596.382.0499.2796.692.04
2801999-80199994.86895.17
3827706-82770697.90998.23
4822788-82278897.32897.64
5794335-79433593.96294.26
6805282-80528295.25795.56
20min1838794-83879499.22196.931.8799.7197.401.87
2808024-80802495.58196.04
3830563-83056398.24798.73
4828515-82851598.00598.48
5800001-80000194.63295.09
6810577-81057795.88396.35
30min1841426-84142699.53297.651.64100.1898.281.64
2821067-82106797.12497.74
3834969-83496998.76999.41
4833496-83349698.59499.23
5805192-80519295.24695.86
6817036-81703696.64797.27
45min1840253-84025399.39497.801.62100.2198.601.62
2826837-82683797.80798.59
3833460-83346098.59099.40
4836986-83698699.00799.81
5804543-80454395.16995.94
6818588-81858896.83197.62
60min1839952-83995299.35897.871.62100.3498.831.62
2829051-82905198.06899.01
3832638-83263898.49399.47
4839013-83901399.247100.22
5805385-80538595.26996.20
6818128-81812896.77697.72
极限1839777-83977799.33797.841.65100.4898.961.65
2829736-82973698.14999.25
3830942-83094298.29299.43
4839612-83961299.318100.45
5804797-80479795.19996.29
6817661-81766196.72197.83
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%
111.807541767543557535227525917524347534160.12
211.797606587593417600000.13
单位质量响应值RSD%判断
63848.8164461.410.68数据可信
中间条件12月-供试品溶液-2024072721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%
5min1789011-78901192.83090.052.9992.8390.052.99
2780377-78037791.81491.81
3782293-78229392.04092.04
4736793-73679386.68686.69
5765148-76514890.02290.02
6738560-73856086.89486.89
10min1826149-82614997.19994.572.7697.3594.722.76
2807282-80728294.98095.13
3832577-83257797.95698.11
4780009-78000991.77191.92
5794390-79439093.46393.61
6782213-78221392.03092.18
15min1834210-83421098.14895.712.2598.4696.012.25
2810750-81075095.38895.70
3837472-83747298.53298.85
4798645-79864593.96394.26
5805050-80505094.71795.02
6794614-79461493.48993.79
20min1835149-83514998.25896.112.0098.7496.582.00
2809825-80982595.27995.75
3839414-83941498.76099.24
4808325-80832595.10295.56
5808609-80860995.13695.60
6799878-79987894.10994.56
30min1837633-83763398.55196.581.8199.1997.211.81
2809226-80922695.20895.84
3841710-84171099.03099.68
4816136-81613696.02196.63
5812624-81262495.60896.23
6808176-80817695.08595.70
45min1836917-83691798.46696.681.6799.2797.471.67
2806147-80614794.84695.63
3839414-83941498.76099.57
4821548-82154896.65897.43
5811986-81198695.53396.31
6814420-81442095.81996.59
60min1836579-83657998.42796.821.6899.4097.771.68
2806920-80692094.93795.88
3841571-84157199.01499.99
4824429-82442996.99797.93
5813518-81351895.71396.65
6814543-81454395.83496.76
极限1836144-83614498.37596.781.6499.5197.891.64
2804759-80475994.68395.79
3840079-84007998.83899.98
4823026-82302696.83297.93
5816535-81653596.06897.17
6814734-81473495.85696.95
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%
111.807549327546387556987555347557607553120.07
211.797589927586867588390.03
单位质量响应值RSD%判断
64009.4964362.930.39数据可信
中间条件12月-供试品溶液-2024072921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%
5min1790885-79088593.00492.712.5493.0092.712.54
2761934-76193489.60089.60
3809948-80994895.24695.25
4766677-76667790.15790.16
5794513-79451393.43193.43
6806276-80627694.81494.81
10min1822365-82236596.70696.430.7796.8696.580.77
2810589-81058995.32195.47
3827129-82712997.26697.42
4817084-81708496.08596.24
5817004-81700496.07596.23
6825704-82570497.09997.26
15min1826832-82683297.23196.710.7497.5597.020.74
2814757-81475795.81196.12
3830270-83027097.63597.96
4821605-82160596.61796.93
5816221-81622195.98396.30
6824499-82449996.95797.28
20min1831333-83133397.76096.750.7398.2497.230.72
2815682-81568295.92096.39
3826993-82699397.25097.73
4822246-82224696.69297.16
5816968-81696896.07196.55
6823209-82320996.80597.29
30min1835441-83544198.24496.820.8898.8897.460.88
2818359-81835996.23596.86
3826618-82661897.20697.85
4824618-82461896.97197.60
5815317-81531795.87796.51
6819842-81984296.40997.05
45min1831061-83106197.72896.830.7798.5397.630.77
2818504-81850496.25297.04
3829149-82914997.50498.31
4825873-82587397.11897.91
5814783-81478395.81496.61
6821307-82130796.58197.38
60min1837116-83711698.44196.970.9099.4197.930.89
2821927-82192796.65497.60
3826996-82699697.25098.22
4826181-82618197.15598.11
5816197-81619795.98196.94
6819297-81929796.34597.31
极限1836030-83603098.31396.850.8799.4497.970.87
2819893-81989396.41597.52
3824986-82498697.01498.15
4826033-82603397.13798.26
5817452-81745296.12897.24
6817092-81709296.08697.21
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%
111.807589267579117568157557347555217569810.20
211.797712147665967689050.43
单位质量响应值RSD%判断
64150.9365216.711.17数据可信
中间条件12月-供试品溶液-2024072921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%
5min1779493-77949390.96593.133.1390.9693.133.13
2811658-81165894.71894.72
3816925-81692595.33395.33
4809757-80975794.49694.50
5814717-81471795.07595.08
6755617-75561788.17888.18
10min1816728-81672895.31095.831.0795.4695.981.08
2826192-82619296.41496.57
3829129-82912996.75796.92
4822807-82280796.01996.18
5826699-82669996.47396.63
6805541-80554194.00494.15
15min1814760-81476095.08096.230.8695.3996.540.87
2827143-82714396.52596.84
3830273-83027396.89197.21
4826985-82698596.50796.82
5831660-83166097.05297.37
6816847-81684795.32495.63
20min1814216-81421695.01796.160.9095.4996.630.90
2826307-82630796.42896.91
3827860-82786096.60997.09
4827201-82720196.53297.01
5832723-83272397.17697.66
6815595-81559595.17895.64
30min1813405-81340594.92296.231.0395.5596.871.03
2825376-82537696.31996.96
3830551-83055196.92397.57
4829860-82986096.84297.48
5833521-83352197.27097.91
6815177-81517795.12995.75
45min1816764-81676495.31496.490.6896.1097.290.68
2824435-82443596.20997.01
3829352-82935296.78397.59
4828872-82887296.72797.53
5832730-83273097.17797.98
6828957-82895796.73797.52
60min1817377-81737795.38696.350.8596.3397.300.84
2826688-82668896.47297.43
3824762-82476296.24797.21
4818389-81838995.50496.47
5834911-83491197.43298.40
6831490-83149097.03397.97
极限1813107-81310794.88796.481.0195.9997.601.00
2825367-82536796.31897.44
3823810-82381096.13697.26
4829241-82924196.77097.89
5837386-83738697.72198.85
6831854-83185497.07598.18
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