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%
111.807563747558557566667565167563527563530.05
211.797561117570317565710.09
单位质量响应值RSD%判断
64097.7164170.570.09数据可信
中间条件12月-供试品溶液-2024073021批-20mg规格-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%
5min1761690-76169089.64388.815.5889.6488.815.58
2748966-74896688.14588.15
3736119-73611986.63386.63
4800221-80022194.17894.18
5685992-68599280.73480.73
6794920-79492093.55493.55
10min1801757-80175794.35893.063.9794.5193.203.97
2788389-78838992.78592.93
3761418-76141889.61189.76
4819044-81904496.39396.55
5747348-74734887.95588.09
6826148-82614897.22997.38
15min1805515-80551594.80194.043.2895.1194.343.28
2798857-79885794.01794.32
3774048-77404891.09791.39
4820746-82074696.59396.91
5763753-76375389.88690.17
6831254-83125497.83098.15
20min1812573-81257395.63194.572.9096.1095.032.91
2804099-80409994.63495.09
3778377-77837791.60792.05
4822466-82246696.79697.27
5773333-77333391.01391.44
6830406-83040697.73098.21
30min1823659-82365996.93695.532.2297.5696.152.23
2812125-81212595.57996.19
3790265-79026593.00693.60
4822374-82237496.78597.42
5789767-78976792.94793.53
6832172-83217297.93898.58
45min1832131-83213197.93396.561.3398.7297.341.34
2824510-82451097.03697.81
3804421-80442194.67295.43
4821999-82199996.74197.54
5810579-81057995.39796.13
6829294-82929497.59998.41
60min1832667-83266797.99696.841.0998.9497.781.09
2828626-82862697.52198.46
3812065-81206595.57196.48
4814703-81470395.88296.84
5818289-81828996.30497.20
6830718-83071897.76798.74
极限1831785-83178597.89297.270.8899.0098.370.88
2831233-83123397.82798.93
3816042-81604296.04097.11
4818348-81834896.31197.43
5830833-83083397.78098.84
6830697-83069797.76498.90
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%
111.807567357555687565447549877536537554970.17
211.797561437550737556080.11
单位质量响应值RSD%判断
64025.1764088.890.08数据可信
中间条件12月-供试品溶液-2024073021批-20mg规格-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%
5min1790028-79002893.09091.043.5793.0991.043.57
2780412-78041291.95791.96
3774760-77476091.29191.29
4718900-71890084.70984.71
5795738-79573893.76393.76
6775848-77584891.41991.42
10min1826737-82673797.41594.713.2797.5794.863.27
2822273-82227396.88997.04
3807985-80798595.20695.36
4753457-75345788.78188.92
5808828-80882895.30595.46
6803374-80337494.66294.81
15min1827050-82705097.45295.492.4197.7795.802.41
2822943-82294396.96897.28
3815111-81511196.04596.36
4772964-77296491.07991.37
5816236-81623696.17896.49
6807899-80789995.19695.51
20min1827299-82729997.48295.862.0897.9696.332.08
2825128-82512897.22697.70
3815592-81559296.10296.57
4780832-78083292.00692.45
5818044-81804496.39196.87
6814479-81447995.97196.44
30min1833076-83307698.16296.441.5198.8097.061.52
2825456-82545697.26497.90
3817321-81732196.30696.94
4796790-79679093.88794.48
5822772-82277296.94897.58
6815201-81520196.05696.68
45min1831342-83134297.95896.801.0998.7697.591.10
2828049-82804997.57098.37
3819965-81996596.61797.41
4808375-80837595.25296.00
5827184-82718497.46898.27
6814216-81421695.94096.73
60min1829276-82927697.71596.820.8398.6897.770.83
2826945-82694597.44098.40
3817383-81738396.31397.27
4812743-81274395.76696.68
5826574-82657497.39698.36
6817271-81727196.30097.25
极限1829463-82946397.73796.890.7998.8798.000.79
2826178-82617897.34998.48
3817575-81757596.33697.45
4816346-81634696.19197.26
5828397-82839797.61198.73
6815613-81561396.10597.21
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%
111.807562347560457557867542667559087556480.11
211.797544507532187538340.12
单位质量响应值RSD%判断
64037.9763938.420.12数据可信
中间条件12月-供试品溶液-BXJX091批-20mg规格-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%
5min1722994-72299485.28386.923.5585.2886.923.55
2775406-77540691.46591.47
3714655-71465584.29984.30
4727676-72767685.83585.84
5716440-71644084.51084.51
6763946-76394690.11390.11
10min1769101-76910190.72292.892.0190.8693.042.01
2799143-79914394.26594.42
3779215-77921591.91592.06
4779938-77993892.00092.14
5784901-78490192.58592.73
6812686-81268695.86396.01
15min1785848-78584892.69794.321.2692.9994.621.27
2804432-80443294.88995.20
3799862-79986294.35094.64
4792904-79290493.52993.83
5799108-79910894.26194.56
6815378-81537896.18096.49
20min1798076-79807694.13995.080.8494.5995.540.84
2804206-80420694.86295.33
3807582-80758295.26195.71
4801232-80123294.51294.96
5807786-80778695.28595.74
6817527-81752796.43496.90
30min1804208-80420894.86395.650.7595.4796.260.75
2803156-80315694.73995.36
3814945-81494596.12996.74
4810103-81010395.55896.17
5816163-81616396.27396.88
6816731-81673196.34096.97
45min1809366-80936695.47196.150.8996.2396.920.88
2803501-80350194.77995.56
3821426-82142696.89497.66
4816162-81616296.27397.04
5820205-82020596.75097.52
6819839-81983996.70797.50
60min1811156-81115695.68296.100.9196.6097.040.90
2801681-80168194.56595.51
3821800-82180096.93897.87
4816829-81682996.35197.28
5820480-82048096.78297.71
6816491-81649196.31297.26
极限1810579-81057995.61496.091.1596.7097.181.13
2798157-79815794.14995.25
3824945-82494597.30998.40
4818043-81804396.49597.58
5819647-81964796.68497.78
6816065-81606596.26197.37
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%
111.807520087515617535677540777520287526480.15
211.797537057537937537490.01
单位质量响应值RSD%判断
63783.7363931.210.17数据可信
中间条件12月-供试品溶液-BXJX091批-20mg规格-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%
5min1722212-72221285.36587.515.2085.3787.515.20
2691148-69114881.69381.69
3760615-76061589.90489.90
4766703-76670390.62490.62
5791523-79152393.55893.56
6710188-71018883.94483.94
10min1780251-78025192.22592.732.5792.3792.872.57
2761433-76143390.00190.14
3794195-79419593.87394.02
4794728-79472893.93694.09
5813119-81311996.11096.27
6763220-76322090.21290.35
15min1790585-79058593.44794.231.9093.7494.531.91
2786188-78618892.92793.21
3811439-81143995.91296.22
4800134-80013494.57594.88
5817114-81711496.58296.90
6778036-77803691.96392.25
20min1795158-79515893.98794.961.3794.4495.421.38
2798873-79887394.42694.87
3818619-81861996.76097.23
4802051-80205194.80295.27
5814574-81457496.28296.76
6790973-79097393.49393.94
30min1802172-80217294.81695.831.1995.4296.451.19
2815593-81559396.40397.00
3824427-82442797.44798.07
4802814-80281494.89295.52
5817436-81743696.62197.26
6802217-80221794.82295.42
45min1803345-80334594.95596.281.4195.7297.051.40
2825387-82538797.56098.32
3828700-82870097.95298.74
4801275-80127594.71095.49
5818526-81852696.74997.55
6809979-80997995.73996.50
60min1806074-80607495.27896.251.4996.2097.191.48
2829947-82994798.09999.02
3828383-82838397.91498.87
4800488-80048894.61795.56
5811923-81192395.96996.93
6809020-80902095.62696.54
极限1806236-80623695.29796.141.5096.3897.241.49
2828239-82823997.89798.98
3826865-82686597.73598.85
4798333-79833394.36395.46
5814863-81486396.31697.44
6805930-80593095.26196.34
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