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%
111.917518767546447523367508877507357520960.21
211.917615737619007617360.04
单位质量响应值RSD%判断
63148.2863957.680.91数据可信
供试品溶液-2024072721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%
5min1829191-82919198.89996.681.5498.9096.681.54
2796605-79660595.01295.01
3810410-81041096.65996.66
4808054-80805496.37896.38
5799006-79900695.29895.30
6820377-82037797.84797.85
10min1846531-846531100.96798.451.87101.1398.621.87
2806638-80663896.20996.37
3813337-81333797.00897.17
4831507-83150799.17599.34
5817340-81734097.48597.64
6837410-83741099.879100.04
15min1847619-847619101.09798.072.77101.4398.392.76
2810950-81095096.72397.04
3785058-78505893.63593.96
4837948-83794899.943100.27
5816913-81691397.43497.76
6834769-83476999.56499.89
20min1849228-849228101.28898.532.06101.7999.022.06
2810208-81020896.63597.11
3809721-80972196.57697.06
4841067-841067100.315100.81
5814661-81466197.16697.65
6831783-83178399.20899.70
30min1846977-846977101.02097.811.92101.6998.461.92
2811701-81170196.81397.45
3808380-80838096.41797.06
4831295-83129599.15099.81
5808876-80887696.47697.12
6813040-81304096.97297.63
45min1846497-846497100.96398.612.67101.8099.432.66
2807756-80775696.34297.14
3808054-80805496.37897.18
4859955-859955102.568103.39
5811880-81188096.83497.64
6826548-82654898.58399.41
60min1837699-83769999.91398.251.24100.9299.231.24
2823997-82399798.27999.24
3808621-80862196.44597.41
4829612-82961298.94999.94
5816527-81652797.38898.36
6826177-82617798.53999.53
极限1833481-83348199.41097.352.12100.5898.502.11
2807440-80744096.30497.43
3809109-80910996.50397.63
4834001-83400199.472100.63
5789890-78989094.21195.34
6823426-82342698.21199.36
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%
111.917549647543197543307537577540087542760.07
211.917535437543767539600.08
单位质量响应值RSD%判断
63331.3263304.790.03数据可信
供试品溶液-2024072721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%
5min1812627-81262797.27996.781.2897.2896.781.28
2796866-79686695.39295.39
3813459-81345997.37897.38
4809564-80956496.91296.91
5795686-79568695.25195.25
6822353-82235398.44398.44
10min1829075-82907599.24898.241.0399.4198.401.03
2813826-81382697.42297.58
3828706-82870699.20499.37
4822979-82297998.51898.68
5807899-80789996.71396.87
6821540-82154098.34698.51
15min1829009-82900999.24097.831.4599.5798.151.45
2814156-81415697.46297.78
3823549-82354998.58698.91
4825092-82509298.77199.10
5796201-79620195.31295.63
6815216-81521697.58997.92
20min1824406-82440698.68997.951.0399.1898.441.03
2811798-81179897.17997.66
3822378-82237898.44698.94
4826224-82622498.90699.40
5804548-80454896.31296.79
6820115-82011598.17598.67
30min1829340-82934099.27997.901.2299.9498.561.22
2811755-81175597.17497.82
3825209-82520998.78599.44
4819999-81999998.16198.82
5801694-80169495.97096.61
6819148-81914898.05998.71
45min1828117-82811799.13398.141.2799.9698.951.27
2810297-81029797.00097.81
3824147-82414798.65899.48
4825010-82501098.76199.58
5803373-80337396.17196.97
6827825-82782599.09899.92
60min1826097-82609798.89197.671.4599.8898.641.44
2808975-80897596.84297.81
3826021-82602198.88299.87
4824462-82446298.69599.68
5797110-79711095.42196.38
6812545-81254597.26998.25
极限1820784-82078498.25597.351.0299.4198.491.02
2807429-80742996.65697.79
3818748-81874898.01199.16
4819950-81995098.15599.30
5800073-80007395.77696.89
6812401-81240197.25298.40
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%
111.917521437521147519817521677521877521180.02
211.917550307548807549550.02
单位质量响应值RSD%判断
63150.1363388.330.27数据可信
供试品溶液-2024072921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%
5min1808222-80822296.82695.514.1596.8395.514.15
2756257-75625790.60190.60
3809649-80964996.99797.00
4825315-82531598.87498.87
5828563-82856399.26399.26
6755581-75558190.52090.52
10min1818749-81874998.08898.612.1498.2598.772.14
2796004-79600495.36395.51
3821193-82119398.38098.54
4840918-840918100.743100.91
5844099-844099101.125101.29
6817699-81769997.96298.11
15min1811231-81123197.18798.512.2097.5198.842.19
2797956-79795695.59795.91
3818925-81892598.10998.43
4844535-844535101.177101.51
5842063-842063100.881101.21
6819115-81911598.13198.45
20min1816477-81647797.81598.611.9498.3099.101.94
2799845-79984595.82396.29
3821779-82177998.45198.94
4841968-841968100.869101.37
5840369-840369100.678101.18
6818329-81832998.03798.51
30min1817141-81714197.89598.212.5998.5498.872.59
2786612-78661294.23794.87
3816445-81644597.81298.46
4842753-842753100.963101.63
5843197-843197101.016101.69
6812720-81272097.36598.01
45min1811248-81124897.18998.201.4098.0099.011.41
2810622-81062297.11497.90
3819410-81941098.16798.98
4827364-82736499.12099.96
5838752-838752100.484101.32
6810627-81062797.11597.92
60min1825735-82573598.92498.981.4299.9099.961.42
2807292-80729296.71597.66
3818575-81857598.06799.05
4835733-835733100.122101.13
5838075-838075100.403101.41
6832031-83203199.679100.64
极限1811894-81189497.26698.561.3598.4199.711.35
2823816-82381698.69599.80
3815365-81536597.68298.83
4835255-835255100.065101.23
5836643-836643100.231101.40
6813311-81331197.43698.57
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%
111.917534227531767532337536077537987534470.04
211.917523847524077523960.01
单位质量响应值RSD%判断
63261.7163173.470.10数据可信
供试品溶液-2024072921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%
5min1814043-81404397.60396.931.5297.6096.921.52
2830566-83056699.58499.58
3805386-80538696.56596.57
4797684-79768495.64295.64
5800906-80090696.02896.03
6801771-80177196.13296.13
10min1824664-82466498.87798.581.5899.0498.741.59
2845037-845037101.319101.49
3824342-82434298.83899.00
4807111-80711196.77296.93
5814430-81443097.65097.81
6817470-81747098.01498.17
15min1824872-82487298.90298.431.6599.2398.761.65
2842719-842719101.041101.38
3826757-82675799.12899.45
4805094-80509496.53096.85
5810549-81054997.18497.51
6815645-81564597.79598.12
20min1821182-82118298.45998.441.6698.9598.921.66
2847135-847135101.571102.07
3816576-81657697.90798.40
4809010-80901097.00097.48
5812006-81200697.35997.84
6820044-82004498.32398.81
30min1813498-81349897.53898.121.3498.1998.771.35
2840248-840248100.745101.42
3813380-81338097.52498.18
4812264-81226497.39098.03
5812481-81248197.41698.06
6818094-81809498.08998.74
45min1820351-82035198.35997.751.6199.1898.571.61
2838772-838772100.568101.41
3801631-80163196.11596.93
4807724-80772496.84597.65
5809422-80942297.04997.86
6813798-81379897.57498.39
60min1819114-81911498.21197.831.2999.1998.801.29
2835051-835051100.122101.13
3812529-81252997.42298.40
4805582-80558296.58997.56
5808680-80868096.96097.93
6814421-81442197.64898.62
极限1812923-81292397.46997.290.8498.6298.430.85
2822670-82267098.63899.81
3807795-80779596.85497.99
4803124-80312496.29497.42
5807998-80799896.87898.01
6814014-81401497.60098.74
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