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625
标示量(mg)20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%
117.629528869519489521559519249523529522530.05
217.509551039547209549120.03
单位质量响应值RSD%判断
54043.8754566.400.69数据可信
长期36月-供试品溶液-2022051801批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11014917-101491794.63495.151.5894.6395.151.58
21010381-101038194.21194.21
31011149-101114994.28394.28
41032397-103239796.26496.26
51006534-100653493.85293.85
61047465-104746597.66997.67
10min11056015-105601598.46699.103.2198.6299.263.21
21045049-104504997.44497.60
31045461-104546197.48297.64
41065298-106529899.33299.49
51035912-103591296.59296.75
61129345-1129345105.304105.47
15min11073418-1073418100.08998.921.27100.4199.241.27
21058744-105874498.72199.04
31055728-105572898.43998.76
41080524-1080524100.751101.08
51046232-104623297.55497.87
61050430-105043097.94598.28
20min11080928-1080928100.78999.581.30101.28100.071.29
21064131-106413199.22399.71
31061039-106103998.93599.42
41087106-1087106101.365101.86
51065326-106532699.33499.81
61049257-104925797.83698.34
30min11084562-1084562101.12899.711.69101.78100.361.68
21074617-1074617100.201100.85
31062665-106266599.08699.73
41093394-1093394101.951102.61
51054289-105428998.30598.95
61046470-104647097.57698.24
45min11081775-1081775100.86899.641.62101.69100.461.62
21073581-1073581100.104100.92
31064207-106420799.230100.04
41092166-1092166101.837102.67
51053806-105380698.26099.07
61046132-104613297.54598.37
极限11079612-1079612100.66699.901.12101.66100.891.12
21070910-107091099.855100.84
31060616-106061698.89599.87
41089273-1089273101.567102.57
51057123-105712398.56999.54
61071021-107102199.865100.86
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625
标示量(mg)20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%
117.629550639555559547209540569543169547420.07
217.509542049543099542560.01
单位质量响应值RSD%判断
54185.1354528.910.45数据可信
长期36月-供试品溶液-2022051901批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11015873-101587394.63194.422.0694.6394.422.06
21021395-102139595.14695.15
3988844-98884492.11492.11
4990811-99081192.29792.30
51043886-104388697.24197.24
61021125-102112595.12195.12
10min11056217-105621798.39098.151.5798.5598.311.57
21045046-104504697.34997.51
31037280-103728096.62696.78
41038131-103813196.70596.86
51077311-1077311100.355100.52
61068017-106801799.48999.65
15min11071812-107181299.84299.301.55100.1699.621.55
21053300-105330098.11898.44
31051270-105127097.92998.24
41051434-105143497.94498.26
51090356-1090356101.570101.90
61077598-1077598100.381100.71
20min11075156-1075156100.15499.871.57100.64100.351.58
21056334-105633498.40198.88
31055318-105531898.30698.78
41064227-106422799.13699.61
51098424-1098424102.321102.82
61083049-1083049100.889101.38
30min11080308-1080308100.634100.271.34101.29100.921.34
21065592-106559299.26399.91
31056687-105668798.43399.08
41072535-107253599.910100.55
51095636-1095636102.062102.73
61087697-1087697101.322101.98
45min11079575-1079575100.565100.231.40101.39101.051.40
21059338-105933898.68099.49
31056612-105661298.42699.23
41080999-1080999100.698101.51
51095309-1095309102.031102.87
61083831-1083831100.962101.79
极限11077423-1077423100.365100.031.38101.36101.021.38
21065083-106508399.216100.19
31054958-105495898.27299.24
41066483-106648399.346100.32
51096574-1096574102.149103.16
61082360-1082360100.825101.82
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625
标示量(mg)20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%
117.629575169583909570189569859562809572380.09
217.509596639588619592620.06
单位质量响应值RSD%判断
54326.7954814.970.64数据可信
长期36月-供试品溶液-2022052001批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11002780-100278093.04793.691.0193.0593.691.01
21023367-102336794.95794.96
31005622-100562293.31093.31
4995949-99594992.41392.41
51013616-101361694.05294.05
61017073-101707394.37394.37
10min11031264-103126495.69096.700.8295.8496.860.82
21054988-105498897.89198.05
31041887-104188796.67596.83
41035200-103520096.05596.21
51047432-104743297.19097.35
61042310-104231096.71596.87
15min11044026-104402696.87497.631.0197.1997.951.01
21070067-107006799.29099.61
31052383-105238397.64997.97
41049330-104933097.36697.68
51056858-105685898.06498.38
61040386-104038696.53696.85
20min11047018-104701897.15198.571.6097.6399.051.59
21071795-107179599.45099.94
31075774-107577499.820100.30
41079854-1079854100.198100.67
51061931-106193198.53599.02
61037430-103743096.26296.74
30min11054335-105433597.83098.231.3898.4798.871.37
21064373-106437398.76299.41
31056879-105687998.06698.71
41057598-105759898.13398.78
51081594-1081594100.360101.01
61036929-103692996.21596.86
45min11054369-105436997.83498.031.0998.6398.841.08
21070872-107087299.365100.18
31056570-105657098.03898.85
41055374-105537497.92798.73
51064578-106457898.78199.59
61037071-103707196.22897.03
极限11053890-105389097.78998.400.8898.7599.370.88
21076059-107605999.846100.83
31055905-105590597.97698.95
41055621-105562197.95098.92
51067701-106770199.071100.05
61053357-105335797.74098.70
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625
标示量(mg)20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%
117.629533759533979529029524549520579528370.07
217.509551069557819554440.05
单位质量响应值RSD%判断
54077.0154596.800.68数据可信
长期36月-供试品溶液-EW4378批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11010632-101063294.17992.101.4694.1892.101.46
2988655-98865592.13192.13
3984462-98446291.74191.74
4997707-99770792.97592.97
5978023-97802391.14191.14
6970284-97028490.41990.42
10min11054985-105498598.31296.531.1398.4796.691.13
21038020-103802096.73296.89
31027466-102746695.74895.90
41041947-104194797.09897.25
51029749-102974995.96196.11
61023250-102325095.35595.51
15min11068951-106895199.61498.120.9799.9398.430.97
21057643-105764398.56098.87
31041824-104182497.08697.40
41054121-105412198.23298.55
51052857-105285798.11498.43
61042088-104208897.11197.42
20min11078184-1078184100.47498.661.38100.9699.131.38
21068902-106890299.609100.09
31040876-104087696.99897.47
41059821-105982198.76399.24
51061430-106143098.91399.39
61042815-104281597.17897.65
30min11076429-1076429100.311100.042.27100.97100.682.26
21075740-1075740100.247100.89
31058163-105816398.60999.24
41117355-1117355104.125104.77
51067349-106734999.465100.10
61046323-104632397.50598.14
45min11077342-1077342100.39699.011.45101.2299.821.44
21076842-1076842100.349101.16
31038914-103891496.81597.62
41067589-106758999.487100.31
51064280-106428099.17999.98
61049722-104972297.82298.62
极限11079582-1079582100.60599.401.53101.59100.371.53
21079968-1079968100.641101.62
31041247-104124797.03297.99
41079086-1079086100.558101.54
51066526-106652699.388100.36
61053395-105339598.16499.12
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