盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.073799353801933797663795413796683798210.07
212.153792033794153793090.04
单位质量响应值RSD%判断
31468.1931218.850.57数据可信
长期6月-供试品溶液-2023120221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%
2min1324573-32457378.49275.828.3178.4975.828.31
2324591-32459178.49678.50
3317317-31731776.73776.74
4343544-34354483.08083.08
5303753-30375373.45773.46
6267306-26730664.64364.64
5min1396454-39645495.87596.721.0595.8896.721.05
2403151-40315197.49597.49
3404590-40459097.84397.84
4402875-40287597.42897.43
5394323-39432395.36095.36
6398176-39817696.29296.29
10min1395270-39527095.58997.701.4195.5997.701.41
2410288-41028899.22199.22
3408626-40862698.81998.82
4406962-40696298.41698.42
5402301-40230197.28997.29
6400513-40051396.85796.86
15min1403358-40335897.54598.301.1897.5498.301.18
2411172-41117299.43499.43
3413048-41304899.88899.89
4402492-40249297.33597.34
5401724-40172497.15097.15
6406983-40698398.42198.42
20min1400235-40023596.79097.661.8396.7997.661.83
2409877-40987799.12199.12
3409521-40952199.03599.04
4410329-41032999.23199.23
5401079-40107996.99496.99
6391964-39196494.78994.79
30min1402206-40220697.26698.991.1897.2798.991.18
2415239-415239100.418100.42
3412675-41267599.79899.80
4409654-40965499.06799.07
5405251-40525198.00398.00
6411031-41103199.40099.40
45min1397268-39726896.07299.301.8896.0799.301.88
2415904-415904100.579100.58
3419376-419376101.418101.42
4409288-40928898.97998.98
5408619-40861998.81798.82
6413340-41334099.95999.96
极限1403239-40323997.51699.311.1897.5299.301.18
2417075-417075100.862100.86
3413378-41337899.96899.97
4412200-41220099.68399.68
5407429-40742998.52998.53
6410507-41050799.27499.27
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.073800593798943799033802413799263800050.04
212.153794453791733793090.06
单位质量响应值RSD%判断
31483.4331218.850.60数据可信
长期6月-供试品溶液-2023120521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%
2min1329042-32904279.55477.685.0679.5577.685.06
2310611-31061175.09775.10
3315241-31524176.21776.22
4350976-35097684.85784.86
5313468-31346875.78875.79
6308429-30842974.57074.57
5min1391370-39137094.62394.811.1694.6294.811.16
2399103-39910396.49296.49
3394034-39403495.26795.27
4393268-39326895.08295.08
5385722-38572293.25793.26
6389271-38927194.11594.12
10min1393916-39391695.23895.121.5495.2495.121.54
2401692-40169297.11897.12
3399172-39917296.50996.51
4390762-39076294.47694.48
5386132-38613293.35693.36
6388839-38883994.01194.01
15min1394713-39471395.43195.580.9595.4395.580.95
2399564-39956496.60496.60
3399825-39982596.66796.67
4394072-39407295.27695.28
5390026-39002694.29894.30
6393841-39384195.22095.22
20min1398340-39834096.30894.363.3196.3194.363.31
2402389-40238997.28797.29
3398015-39801596.22996.23
4394467-39446795.37295.37
5370589-37058989.59989.60
6377842-37784291.35291.35
30min1400585-40058596.85195.722.0696.8595.722.06
2401840-40184097.15497.15
3398829-39882996.42696.43
4396421-39642195.84495.84
5379720-37972091.80691.81
6397970-39797096.21996.22
45min1398498-39849896.34695.970.9796.3595.970.97
2400208-40020896.76096.76
3400145-40014596.74496.74
4396419-39641995.84495.84
5396517-39651795.86795.87
6389854-38985494.25694.26
极限1403548-40354897.56795.722.0197.5795.722.01
2402617-40261797.34297.34
3399009-39900996.47096.47
4384969-38496993.07593.08
5387077-38707793.58593.58
6398279-39827996.29396.29
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5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%
112.073801253799473801093798353798073799650.04
212.153826943826153826540.02
单位质量响应值RSD%判断
31480.1231494.160.04数据可信
长期6月-供试品溶液-2023120621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%
2min1346950-34695083.52076.368.9083.5276.368.91
2353662-35366285.13585.14
3310583-31058374.76574.77
4285241-28524168.66568.66
5290673-29067369.97269.97
6316116-31611676.09776.10
5min1403267-40326797.07695.941.7197.0895.941.71
2405231-40523197.54997.55
3404245-40424597.31297.31
4392679-39267994.52894.53
5388820-38882093.59993.60
6396932-39693295.55195.55
10min1405518-40551897.61896.381.9597.6296.381.95
2403865-40386597.22097.22
3408656-40865698.37498.37
4400048-40004896.30296.30
5386709-38670993.09093.09
6397456-39745695.67895.68
15min1399927-39992796.27296.361.7296.2796.361.72
2408674-40867498.37898.38
3407652-40765298.13298.13
4396640-39664095.48195.48
5390552-39055294.01694.02
6398292-39829295.87995.88
20min1402294-40229496.84296.961.5196.8496.961.51
2407532-40753298.10398.10
3411562-41156299.07399.07
4399010-39901096.05296.05
5394500-39450094.96694.97
6401911-40191196.75096.75
30min1403025-40302597.01897.481.1097.0297.481.10
2411064-41106498.95398.95
3409933-40993398.68198.68
4400427-40042796.39396.39
5401935-40193596.75696.76
6403379-40337997.10397.10
45min1405560-40556097.62897.361.7297.6397.361.72
2406101-40610197.75997.76
3413814-41381499.61599.62
4393854-39385494.81094.81
5399466-39946696.16196.16
6407891-40789198.19098.19
极限1405120-40512097.52297.501.4797.5297.501.47
2411107-41110798.96498.96
3411611-41161199.08599.09
4400098-40009896.31496.31
5396641-39664195.48195.48
6405532-40553297.62297.62
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