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对照品来源自制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%
112.117642337632447637587630097642697637030.08
212.147639067621577630320.17
单位质量响应值RSD%判断
63063.8362852.720.24数据可信
供试品溶液-BXJX091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%
5min1615178-61517874.06376.964.9474.0676.964.94
2595608-59560871.70771.71
3650129-65012978.27178.27
4679706-67970681.83281.83
5664713-66471380.02780.03
6629957-62995775.84375.84
10min1692911-69291183.42284.493.0383.5584.623.03
2676366-67636681.43081.55
3709517-70951785.42185.55
4733556-73355688.31588.45
5714021-71402185.96386.10
6684221-68422182.37682.50
15min1718124-71812486.45786.992.4786.7287.262.47
2698966-69896684.15184.41
3725019-72501987.28787.56
4746587-74658789.88490.17
5737833-73783388.83089.11
6708620-70862085.31385.58
20min1716257-71625786.23388.202.3986.6488.612.39
2716420-71642086.25286.65
3731566-73156688.07688.49
4757097-75709791.14991.58
5750341-75034190.33690.76
6723877-72387787.15087.56
30min1741423-74142389.26290.283.0089.8190.842.99
2730653-73065387.96688.51
3736616-73661688.68489.25
4790757-79075795.20295.79
5760465-76046591.55592.13
6739187-73918788.99389.54
45min1738574-73857488.91990.501.9589.6291.211.96
2738873-73887388.95589.64
3749509-74950990.23690.95
4772982-77298293.06293.81
5766353-76635392.26492.99
6743996-74399689.57290.27
60min1759620-75962091.45391.731.6792.3092.591.68
2752743-75274390.62591.46
3754186-75418690.79991.66
4776552-77655293.49294.39
5778945-77894593.78094.66
6749468-74946890.23191.08
极限1782267-78226794.18094.371.3595.1895.381.34
2779497-77949793.84694.83
3768751-76875192.55393.57
4788293-78829394.90595.96
5800674-80067496.39697.43
6783561-78356194.33695.33
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对照品来源自制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%
112.117648987638847649037622587642377640360.15
212.147644857635887640360.09
单位质量响应值RSD%判断
63091.3362935.420.18数据可信
供试品溶液-BXJX091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%
5min1802864-80286496.57593.294.0896.5793.294.08
2804579-80457996.78196.78
3760405-76040591.46891.47
4755403-75540390.86690.87
5800719-80071996.31796.32
6729284-72928487.72487.72
10min1822669-82266998.95797.122.5499.1297.282.54
2822666-82266698.95799.12
3795257-79525795.66095.81
4796663-79666395.82995.98
5829536-82953699.78399.94
6777744-77774493.55393.70
15min1825329-82532999.27798.601.7899.6098.921.78
2828817-82881799.697100.02
3822749-82274998.96799.28
4819423-81942398.56798.88
5830601-83060199.911100.24
6791231-79123195.17695.48
20min1815857-81585798.13897.771.6198.6398.251.60
2796645-79664595.82796.32
3810644-81064497.51197.99
4816595-81659598.22798.70
5834155-834155100.339100.83
6802721-80272196.55897.02
30min1792181-79218195.29098.232.2995.9498.872.28
2800342-80034296.27196.92
3836340-836340100.602101.24
4825357-82535799.28099.92
5835799-835799100.537101.20
6809725-80972597.40098.02
45min1827369-82736999.52399.871.14100.34100.681.13
2818899-81889998.50499.32
3844033-844033101.527102.33
4829733-82973399.807100.61
5838311-838311100.839101.67
6823309-82330999.03499.82
60min1827218-82721899.50499.671.24100.48100.651.23
2816282-81628298.18999.17
3843023-843023101.405102.38
4830235-83023599.867100.84
5836274-836274100.594101.59
6818752-81875298.48699.44
极限1826153-82615399.37699.991.02100.52101.131.02
2825325-82532599.277100.42
3845605-845605101.716102.86
4830797-83079799.935101.07
5836341-836341100.602101.77
6823215-82321599.023100.14
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