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%
117.159334429323259333809328399320069327980.07
217.059310299300539305410.08
单位质量响应值RSD%判断
54390.5554577.180.25数据可信
长期24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%
5min11016041-101604194.42694.261.3594.4394.261.35
2997513-99751392.70492.70
31023189-102318995.09095.09
41021548-102154894.93894.94
5997609-99760992.71392.71
61029433-102943395.67195.67
10min11060275-106027598.53798.491.2698.6998.651.26
21057827-105782798.30998.46
31067943-106794399.25099.41
41063093-106309398.79998.96
51035332-103533296.21996.37
61074191-107419199.83099.99
15min11076217-1076217100.019100.070.95100.34100.390.95
21077286-1077286100.118100.44
31080864-1080864100.450100.77
41083843-1083843100.727101.05
51057186-105718698.25098.56
61084998-1084998100.835101.16
20min11084157-1084157100.756100.591.12101.24101.081.11
21090819-1090819101.376101.86
31083873-1083873100.730101.22
41086759-1086759100.998101.49
51058591-105859198.38098.86
61090181-1090181101.316101.81
30min11092349-1092349101.518100.961.09102.17101.611.09
21093305-1093305101.607102.26
31083691-1083691100.713101.37
41092190-1092190101.503102.16
51063427-106342798.83099.47
61093148-1093148101.592102.25
45min11092555-1092555101.537100.820.92102.36101.640.92
21085952-1085952100.923101.75
31083874-1083874100.730101.56
41090194-1090194101.318102.15
51065584-106558499.03099.84
61090857-1090857101.379102.21
极限11091017-1091017101.394100.781.06102.39101.771.06
21084525-1084525100.791101.78
31082471-1082471100.600101.59
41087098-1087098101.030102.03
51063666-106366698.85299.82
61097505-1097505101.997103.00
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%
117.159280999293709292109288129301869291350.09
217.059320599322379321480.02
单位质量响应值RSD%判断
54176.9754671.440.65数据可信
长期24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%
5min1985832-98583291.72192.820.9491.7292.820.95
2994869-99486992.56192.56
31006310-100631093.62693.63
4992646-99264692.35592.35
51011280-101128094.08894.09
6995101-99510192.58392.58
10min11025203-102520395.38496.330.7195.5496.480.71
21036069-103606996.39596.55
31042317-104231796.97697.13
41042678-104267897.01097.16
51037908-103790896.56696.72
61027908-102790895.63595.79
15min11039686-103968696.73197.490.6997.0497.800.69
21046982-104698297.41097.72
31056382-105638298.28598.60
41053907-105390798.05498.37
51050701-105070197.75698.07
61039417-103941796.70697.02
20min11044031-104403197.13597.800.6197.6198.280.62
21050191-105019197.70998.19
31059074-105907498.53599.02
41057395-105739598.37998.86
51052315-105231597.90698.39
61044035-104403597.13697.61
30min11054335-105433598.09498.420.6398.7399.060.63
21057173-105717398.35899.00
31069035-106903599.462100.11
41059073-105907398.53599.18
51058365-105836598.46999.11
61048976-104897697.59698.23
45min11053192-105319297.98898.210.4098.7999.010.40
21053825-105382598.04798.85
31061709-106170998.78099.59
41058617-105861798.49399.30
51056071-105607198.25699.06
61050024-105002497.69398.49
极限11050349-105034997.72398.070.4398.6999.040.43
21052938-105293897.96498.93
31060479-106047998.66699.64
41056779-105677998.32199.29
51055431-105543198.19699.17
61048333-104833397.53698.50
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%
117.159362839339849334759332729340889342200.13
217.059330389336829333600.05
单位质量响应值RSD%判断
54473.4754742.520.35数据可信
长期24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%
5min11004149-100414993.10993.711.6393.1193.711.63
2995139-99513992.27492.27
3990379-99037991.83291.83
41018465-101846594.43794.44
51030190-103019095.52495.52
61025370-102537095.07795.08
10min11040523-104052396.48297.671.0396.6497.831.03
21059318-105931898.22598.38
31039060-103906096.34696.50
41059157-105915798.21098.37
51064395-106439598.69598.85
61057713-105771398.07698.23
15min11053011-105301197.64098.570.6997.9698.890.69
21064652-106465298.71999.04
31055338-105533897.85698.17
41067471-106747198.98199.30
51071848-107184899.38699.71
61065731-106573198.81999.14
20min11058883-105888398.18498.950.5598.6699.430.56
21067603-106760398.99399.47
31063873-106387398.64799.12
41066919-106691998.92999.42
51076603-107660399.827100.32
61068843-106884399.10899.59
30min11063773-106377398.63899.180.5699.2899.820.56
21071628-107162899.366100.01
31063532-106353298.61599.26
41069835-106983599.20099.85
51079733-1079733100.118100.77
61069071-106907199.12999.78
45min11060273-106027398.31399.100.6199.1299.920.61
21072956-107295699.489100.30
31063715-106371598.63299.44
41067872-106787299.01899.83
51078456-107845699.999100.82
61069527-106952799.17199.99
极限11060252-106025298.31198.730.4399.2899.710.43
21064022-106402298.66199.64
31062829-106282998.55099.52
41063218-106321898.58699.57
51073485-107348599.538100.53
61064985-106498598.75099.73
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