枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数125
标示量(mg)100供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.909875959869259872609856209842379863270.15
217.719858449854919856680.03
单位质量响应值RSD%判断
55102.0755656.010.71数据可信
供试品溶液-EW4376批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11017729-101772993.05694.832.1393.0694.832.13
21039044-103904495.00595.01
31039095-103909595.01095.01
41019505-101950593.21993.22
51029286-102928694.11394.11
61077891-107789198.55798.56
10min11075835-107583598.36997.381.6398.5297.541.62
21053006-105300696.28296.44
31067529-106752997.61097.77
41047527-104752795.78195.94
51053372-105337296.31596.47
61092947-109294799.934100.10
15min11078236-107823698.58997.531.6298.9197.851.61
21053499-105349996.32796.65
31067591-106759197.61597.94
41046761-104676195.71196.03
51060016-106001696.92397.24
61093669-1093669100.000100.33
20min11078361-107836198.60097.491.5999.0897.971.59
21054599-105459996.42796.91
31066970-106697097.55898.04
41046144-104614495.65496.13
51058654-105865496.79897.28
61092502-109250299.893100.39
30min11075530-107553098.34197.291.5798.9997.941.56
21052948-105294896.27696.92
31064507-106450797.33397.98
41043527-104352795.41596.05
51057770-105777096.71797.36
61089819-108981999.648100.31
45min11074506-107450698.24897.231.6799.0698.041.67
21052377-105237796.22497.02
31064322-106432297.31698.12
41041673-104167395.24596.04
51055819-105581996.53997.34
61091545-109154599.806100.64
极限11072649-107264998.07897.081.6199.0598.051.61
21050653-105065396.06797.03
31062154-106215497.11898.09
41040615-104061595.14996.10
51055418-105541896.50297.46
61088781-108878199.553100.55
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数125
标示量(mg)100供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.909856099854129860239859729855259857080.03
217.719859719870249864980.08
单位质量响应值RSD%判断
55067.4955702.880.82数据可信
供试品溶液-EW4376批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11069552-106955297.78596.063.4497.7896.063.44
21078169-107816998.57298.57
31058401-105840196.76596.77
41077482-107748298.51098.51
5984348-98434889.99589.99
61036272-103627294.74294.74
10min11076407-107640798.41198.921.6198.5799.081.60
21100236-1100236100.590100.75
31073591-107359198.15498.32
41097733-1097733100.361100.53
51089605-108960599.61899.77
61054407-105440796.40096.56
15min11077915-107791598.54998.991.6298.8899.311.61
21102532-1102532100.800101.13
31071182-107118297.93498.26
41099472-1099472100.520100.85
51088066-108806699.47799.79
61056979-105697996.63596.95
20min11079080-107908098.65698.921.5899.1599.411.58
21099485-1099485100.521101.02
31071167-107116797.93298.42
41098249-1098249100.408100.91
51088606-108860699.527100.01
61055303-105530396.48296.96
30min11077562-107756298.51798.841.6899.1799.501.68
21098729-1098729100.452101.12
31070574-107057497.87898.53
41096607-1096607100.258100.92
51091625-109162599.803100.45
61051784-105178496.16096.80
45min11074663-107466398.25298.711.6599.0799.531.64
21098245-1098245100.408101.24
31067815-106781597.62698.44
41095920-1095920100.195101.03
51088453-108845399.513100.33
61052889-105288996.26197.06
极限11072896-107289698.09098.561.6399.0799.541.62
21096377-1096377100.237101.24
31067565-106756597.60398.58
41092536-109253699.886100.89
51088047-108804799.475100.46
61050792-105079296.06997.03
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数125
标示量(mg)100供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.909851219849109851019848529844809848930.03
217.719861169862469861810.01
单位质量响应值RSD%判断
55021.9655684.980.85数据可信
供试品溶液-EW4369批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11052427-105242796.27496.612.5596.2796.612.56
21078245-107824598.63698.64
31052963-105296396.32396.32
41038835-103883595.03195.03
51094450-1094450100.118100.12
61019504-101950493.26393.26
10min11083412-108341299.10998.331.9399.2798.481.93
21084816-108481699.23799.40
31075813-107581398.41498.57
41061576-106157697.11197.27
51101540-1101540100.767100.93
61041955-104195595.31695.47
15min11083554-108355499.12298.131.5499.4598.461.54
21080373-108037398.83199.16
31074557-107455798.29998.62
41063941-106394197.32897.65
51089772-108977299.691100.03
61044305-104430595.53195.85
20min11081202-108120298.90798.241.7099.4098.721.70
21081864-108186498.96799.46
31074339-107433998.27998.77
41063394-106339497.27797.76
51097858-1097858100.430100.93
61044549-104454995.55496.03
30min11082608-108260899.03598.341.7699.6998.991.76
21083108-108310899.08199.74
31076439-107643998.47199.12
41062799-106279997.22397.87
51099720-1099720100.601101.27
61045238-104523895.61796.25
45min11080233-108023398.81898.151.8199.6498.961.81
21080762-108076298.86699.69
31075004-107500498.34099.16
41059591-105959196.93097.74
51098925-1098925100.528101.36
61042974-104297495.41096.20
极限11078745-107874598.68297.881.7799.6798.851.77
21077674-107767498.58499.57
31070001-107000197.88298.86
41057115-105711596.70397.67
51095125-1095125100.180101.18
61040921-104092195.22296.17
枸橼酸西地那非片项目信息
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420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数125
标示量(mg)100供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.909840789839889841139838239840049840010.02
217.719853949859019856480.04
单位质量响应值RSD%判断
54972.1255654.880.88数据可信
供试品溶液-EW4369批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min11044464-104446495.61593.793.4195.6293.793.41
2959018-95901887.79387.79
31050517-105051796.16996.17
41045309-104530995.69295.69
51035951-103595194.83694.84
61011620-101162092.60892.61
10min11071224-107122498.06597.940.9298.2298.090.91
21085467-108546799.36999.51
31076000-107600098.50298.66
41060561-106056197.08997.25
51064853-106485397.48297.64
61060839-106083997.11497.27
15min11071728-107172898.11198.291.2498.4398.621.23
21098428-1098428100.555100.87
31075595-107559598.46598.79
41059755-105975597.01597.34
51065895-106589597.57797.90
61070972-107097298.04298.36
20min11070717-107071798.01898.141.3098.5098.621.29
21097473-1097473100.468100.95
31073622-107362298.28498.77
41057431-105743196.80297.29
51062547-106254797.27097.75
61070311-107031197.98198.46
30min11067386-106738697.71398.001.2798.3698.651.26
21095627-1095627100.299100.95
31073773-107377398.29898.95
41056872-105687296.75197.40
51062087-106208797.22897.87
61067645-106764597.73798.38
45min11067100-106710097.68797.811.2998.5098.621.28
21093756-1093756100.127100.94
31068933-106893397.85598.67
41053433-105343396.43697.24
51060340-106034097.06897.88
61067080-106708097.68598.49
极限11065576-106557697.54897.611.1898.5298.581.17
21089326-108932699.722100.70
31066376-106637697.62198.60
41052590-105259096.35997.33
51058546-105854696.90497.87
61064845-106484597.48198.45
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