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%
117.279462319465609457029456759452929458920.06
217.239438109433549435820.04
单位质量响应值RSD%判断
54770.8254763.900.01数据可信
供试品溶液-2024052111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%
5min11027873-102787395.03195.651.7095.0395.651.70
21029737-102973795.20395.20
31025659-102565994.82694.83
41036588-103658895.83795.84
51068413-106841398.77998.78
61019249-101924994.23494.23
10min11065876-106587698.54499.071.9898.7099.231.98
21077416-107741699.61199.77
31073792-107379299.27699.43
41037257-103725795.89996.06
51102971-1102971101.974102.14
61072107-107210799.12199.28
15min11078316-107831699.695100.491.22100.02100.811.22
21085996-1085996100.405100.73
31075731-107573199.45699.78
41088565-1088565100.642100.96
51112059-1112059102.814103.15
61080774-108077499.922100.24
20min11082619-1082619100.092100.761.16100.58101.251.16
21089118-1089118100.693101.19
31075197-107519799.40699.90
41093444-1093444101.093101.58
51112301-1112301102.837103.34
61086272-1086272100.430100.92
30min11089924-1089924100.768101.140.92101.42101.800.92
21093294-1093294101.079101.74
31080699-108069999.915100.57
41095858-1095858101.316101.97
51111257-1111257102.740103.42
61092580-1092580101.013101.67
45min11085082-1085082100.320100.671.80101.14101.501.79
21053305-105330597.38298.21
31089147-1089147100.696101.52
41093976-1093976101.142101.97
51110035-1110035102.627103.48
61101393-1101393101.828102.65
极限11086239-1086239100.427100.890.73101.42101.880.73
21089984-1089984100.773101.76
31081379-108137999.978100.97
41094158-1094158101.159102.15
51104539-1104539102.119103.14
61090890-1090890100.857101.85
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%
117.279456009454639459259460729459479458010.03
217.239446179439359442760.06
单位质量响应值RSD%判断
54765.5554804.180.05数据可信
供试品溶液-2024052111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%
5min11006379-100637993.01492.604.3493.0192.604.34
2917264-91726484.77884.78
31028394-102839495.04995.05
41018336-101833694.11994.12
51037351-103735195.87795.88
61003483-100348392.74692.75
10min11041733-104173396.28298.071.5496.4498.221.53
21060128-106012897.98298.12
31058725-105872597.85298.01
41061954-106195498.15198.31
51090642-1090642100.802100.96
61053075-105307597.33097.48
15min11056687-105668797.66498.981.2597.9899.301.25
21067162-106716298.63298.94
31068990-106899098.80199.12
41074633-107463399.32299.64
51095224-1095224101.225101.55
61062790-106279098.22898.54
20min11054837-105483797.49399.111.1097.9799.591.10
21071896-107189699.06999.54
31070665-107066598.95699.44
41074320-107432099.29399.78
51091558-1091558100.887101.38
61070571-107057198.94799.43
30min11058595-105859597.84099.200.9498.4899.840.94
21073829-107382999.24899.88
31070672-107067298.95699.61
41076018-107601899.450100.10
51089579-1089579100.704101.37
61070957-107095798.98399.63
45min11057496-105749697.73898.880.9498.5499.690.94
21068410-106841098.74799.55
31066994-106699498.61699.43
41069719-106971998.86899.69
51088021-1088021100.560101.39
61068217-106821798.72999.54
极限11054409-105440997.45398.711.0298.4299.691.02
21069194-106919498.82099.78
31063362-106336298.28199.26
41067833-106783398.69499.68
51087459-1087459100.508101.51
61065956-106595698.52099.50
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%
117.279442809444489441069447279443729443870.03
217.239439179434009436580.04
单位质量响应值RSD%判断
54683.6754768.310.11数据可信
供试品溶液-8167339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%
5min11057810-105781097.87396.921.5197.8796.921.51
21040649-104064996.28596.28
31058492-105849297.93697.94
41055619-105561997.67097.67
51018209-101820994.20994.21
61054446-105444697.56197.56
10min11083957-1083957100.292100.051.75100.46100.211.74
21102463-1102463102.004102.16
31088032-1088032100.669100.83
41087440-1087440100.614100.78
51046218-104621896.80096.96
61079728-107972899.901100.06
15min11088212-1088212100.686100.331.82101.02100.661.82
21109266-1109266102.634102.96
31092249-1092249101.059101.39
41092266-1092266101.061101.39
51052319-105231997.36597.68
61071847-107184799.17199.50
20min11088758-1088758100.736100.321.83101.23100.821.83
21110436-1110436102.742103.24
31091736-1091736101.012101.51
41090971-1090971100.941101.44
51052874-105287497.41697.90
61070989-107098999.09299.59
30min11089264-1089264100.783100.171.86101.45100.831.86
21111308-1111308102.823103.50
31082283-1082283100.137100.80
41089722-1089722100.825101.49
51050974-105097497.24097.88
61072374-107237499.22099.88
45min11083336-1083336100.23499.951.85101.07100.781.85
21107285-1107285102.450103.29
31086374-1086374100.516101.35
41088021-1088021100.668101.50
51048546-104854697.01697.82
61068268-106826898.84099.67
极限11082928-1082928100.19799.891.70101.20100.891.70
21105634-1105634102.298103.31
31084188-1084188100.313101.32
41085291-1085291100.415101.42
51051357-105135797.27698.24
61068276-106827698.84199.83
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%
117.279467039464709465259466439466609466000.02
217.239424179410839417500.11
单位质量响应值RSD%判断
54811.8154657.570.20数据可信
供试品溶液-8167339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%
5min11045016-104501696.67492.109.1396.6792.109.12
2980919-98091990.74490.74
3818828-81882875.74975.75
41057238-105723897.80497.80
51047982-104798296.94896.95
61023394-102339494.67494.67
10min11079460-107946099.860100.282.31100.02100.432.31
21073757-107375799.33399.48
31088056-1088056100.655100.78
41130959-1130959104.624104.79
51073085-107308599.27099.43
61058423-105842397.91498.07
15min11084653-1084653100.341100.712.19100.67101.032.19
21077911-107791199.717100.03
31104051-1104051102.135102.43
41128470-1128470104.394104.73
51074085-107408599.36399.69
61062833-106283398.32298.64
20min11082815-1082815100.171101.012.64100.67101.502.63
21079176-107917699.834100.32
31113259-1113259102.987103.45
41139520-1139520105.416105.93
51073684-107368499.32699.82
61062927-106292798.33198.82
30min11082655-1082655100.156101.142.58100.82101.802.57
21085341-1085341100.404101.05
31115428-1115428103.188103.82
41138605-1138605105.332106.02
51072896-107289699.25399.91
61064727-106472798.49799.15
45min11076147-107614799.554100.752.63100.38101.582.62
21075460-107546099.490100.31
31112613-1112613102.927103.73
41136060-1136060105.096105.96
51070827-107082799.06299.89
61063500-106350098.38499.20
极限11078290-107829099.752100.612.53100.75101.612.52
21073494-107349499.308100.29
31109935-1109935102.679103.66
41132462-1132462104.763105.80
51068141-106814198.81399.80
61063304-106330498.36699.34
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