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500
标示量(mg)25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%
117.369555039552359553559539419533819546830.11
217.319530059528609529320.02
单位质量响应值RSD%判断
54993.2655050.950.08数据可信
供试品溶液-2024051911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%
5min11026648-102664894.47893.461.5894.4893.461.58
2989272-98927291.03991.04
31022360-102236094.08494.08
41031276-103127694.90494.90
51003575-100357592.35592.35
61020370-102037093.90193.90
10min11065371-106537198.04297.451.4398.2097.601.43
21032199-103219994.98995.14
31065588-106558898.06298.22
41069818-106981898.45198.61
51049823-104982396.61196.76
61070650-107065098.52898.68
15min11088298-1088298100.15299.141.50100.4799.461.49
21047494-104749496.39796.71
31080641-108064199.44799.77
41087969-1087969100.121100.44
51071063-107106398.56698.88
61088150-1088150100.138100.46
20min11098531-1098531101.093100.131.52101.58100.611.52
21057077-105707797.27997.75
31090791-1090791100.381100.87
41098832-1098832101.121101.61
51083178-108317899.680100.16
61099938-1099938101.223101.71
30min11106792-1106792101.854100.631.61102.51101.281.61
21060304-106030497.57598.21
31093973-1093973100.674101.33
41102860-1102860101.492102.15
51090549-1090549100.359101.00
61106545-1106545101.831102.49
45min11106367-1106367101.814100.461.67102.64101.281.67
21057223-105722397.29298.09
31093565-1093565100.636101.46
41101213-1101213101.340102.17
51087808-1087808100.107100.92
61103664-1103664101.566102.39
极限11105373-1105373101.723100.411.70102.72101.391.70
21055951-105595197.17598.13
31091012-1091012100.401101.39
41100265-1100265101.253102.25
51089203-1089203100.235101.21
61104707-1104707101.662102.66
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500
标示量(mg)25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%
117.369558829576159564729563609571089566870.08
217.319558809555159556980.03
单位质量响应值RSD%判断
55108.7055210.750.14数据可信
供试品溶液-2024051911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%
5min1991739-99173991.03892.200.9491.0492.200.94
21013154-101315493.00493.00
31011374-101137492.84192.84
41013193-101319393.00793.01
5999363-99936391.73891.74
6997327-99732791.55191.55
10min11043862-104386295.82396.491.1695.9796.651.15
21052027-105202796.57296.73
31064520-106452097.71997.87
41066698-106669897.91998.07
51037893-103789395.27595.43
61042041-104204195.65695.81
15min11061866-106186697.47597.951.2797.7998.261.27
21064270-106427097.69698.01
31077924-107792498.95099.27
41088295-108829599.902100.22
51051886-105188696.55996.87
61057961-105796197.11797.43
20min11067532-106753297.99698.661.2898.4799.141.28
21070599-107059998.27798.76
31088125-108812599.886100.37
41095136-1095136100.530101.01
51059842-105984297.29097.76
61067680-106768098.00998.48
30min11072145-107214598.41999.031.3699.0699.671.35
21071000-107100098.31498.96
31090713-1090713100.124100.77
41102244-1102244101.182101.83
51063429-106342997.61998.25
61073223-107322398.51899.16
45min11069851-106985198.20898.871.4099.0199.671.39
21069575-106957598.18398.99
31093045-1093045100.338101.15
41098742-1098742100.861101.68
51062173-106217397.50498.30
61068761-106876198.10898.91
极限11067064-106706497.95398.731.4098.9299.701.40
21064463-106446397.71498.68
31088752-108875299.944100.93
41098970-1098970100.882101.87
51061314-106131497.42598.38
61072584-107258498.45999.42
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500
标示量(mg)25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%
117.369557179563709555599560209557259558780.04
217.319543939554219549070.08
单位质量响应值RSD%判断
55062.1055165.050.14数据可信
供试品溶液-2024051911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%
5min11051635-105163596.61796.051.1396.6296.061.13
21053559-105355996.79496.79
31035566-103556695.14195.14
41042582-104258295.78595.79
51029328-102932894.56894.57
61060358-106035897.41997.42
10min11086271-108627199.79998.671.1799.9698.831.17
21075053-107505398.76998.93
31066300-106630097.96498.12
41065851-106585197.92398.08
51059424-105942497.33397.49
61091295-1091295100.261100.42
15min11085230-108523099.70498.771.07100.0399.091.07
21075920-107592098.84899.17
31068830-106883098.19798.52
41065912-106591297.92998.25
51062633-106263397.62897.95
61091635-1091635100.292100.62
20min11085190-108519099.70098.681.05100.1999.171.05
21074775-107477598.74399.23
31067513-106751398.07698.56
41066202-106620297.95598.44
51061373-106137397.51297.99
61089562-1089562100.102100.60
30min11084309-108430999.61998.731.05100.2899.391.06
21074545-107454598.72299.38
31068636-106863698.17998.83
41065192-106519297.86398.51
51063522-106352297.70998.35
61091776-1091776100.305100.97
45min11083378-108337899.53398.551.10100.3699.371.10
21071423-107142398.43599.25
31066561-106656197.98898.80
41062456-106245697.61198.42
51061945-106194597.56498.37
61090426-1090426100.181101.01
极限11080985-108098599.31498.410.98100.3199.390.99
21068380-106838098.15699.14
31066211-106621197.95698.93
41062407-106240797.60798.58
51061780-106178097.54998.52
61087126-108712699.878100.88
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500
标示量(mg)25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%
117.369546889538269546679551579547279546130.06
217.319519629524189521900.04
单位质量响应值RSD%判断
54989.2355008.090.03数据可信
供试品溶液-2024051911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%
5min1576839-57683953.10756.6813.0753.1156.6813.07
2662673-66267361.00961.01
3578832-57883253.29053.29
4758031-75803169.78869.79
5575061-57506152.94352.94
6542477-54247749.94349.94
10min1906449-90644983.45279.9511.7183.5480.0411.70
2838958-83895877.23977.34
3769845-76984570.87670.96
4955139-95513987.93588.05
5996726-99672691.76491.85
6743441-74344168.44568.53
15min11048705-104870596.54989.619.6396.7889.849.63
2937925-93792586.35086.58
3852357-85235778.47278.68
41027182-102718294.56894.83
51084468-108446899.842100.08
6889294-88929481.87382.07
20min11073565-107356598.83893.657.1199.2394.037.11
2976152-97615289.87090.24
3898359-89835982.70883.05
41051857-105185796.83997.26
51093772-1093772100.698101.11
61009730-100973092.96193.29
30min11076041-107604199.06696.534.6999.6297.064.70
21016865-101686593.61894.14
3964055-96405588.75689.23
41072917-107291798.77899.36
51096713-1096713100.969101.54
61064609-106460998.01398.50
45min11077910-107791099.23898.352.8199.9699.052.84
21052442-105244296.89397.57
31014512-101451293.40194.02
41085486-108548699.935100.68
51094805-1094805100.793101.54
61084666-108466699.860100.51
极限11075773-107577399.04199.760.8599.92100.620.87
21076236-107623699.08499.93
31073904-107390498.86999.65
41090888-1090888100.433101.35
51093314-1093314100.656101.57
61091189-1091189100.460101.28
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