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%
117.279484429486089478399476879474659480080.06
217.239446669459519453080.10
单位质量响应值RSD%判断
54893.3454864.070.04数据可信
供试品溶液-2024052111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%
5min11078926-107892699.54997.673.3799.5597.673.37
21064832-106483298.24898.25
31039007-103900795.86595.87
41004001-100400192.63692.64
51108693-1108693102.295102.30
61055936-105593697.42797.43
10min11089731-1089731100.546101.071.49100.71101.231.49
21081891-108189199.82299.99
31102473-1102473101.721101.88
41105866-1105866102.034102.19
51117856-1117856103.141103.31
61074377-107437799.12999.29
15min11089269-1089269100.503101.181.51100.84101.511.51
21082455-108245599.874100.20
31102824-1102824101.754102.08
41112099-1112099102.609102.93
51117020-1117020103.063103.41
61076097-107609799.28899.62
20min11085928-1085928100.195101.021.51100.70101.521.51
21081828-108182899.816100.31
31101984-1101984101.676102.17
41111156-1111156102.522103.02
51113959-1113959102.781103.30
61074130-107413099.10699.60
30min11093450-1093450100.889100.991.47101.56101.661.47
21081147-108114799.754100.42
31098794-1098794101.382102.05
41111012-1111012102.509103.18
51111501-1111501102.554103.24
61071602-107160298.87399.53
45min11083493-108349399.970100.641.48100.81101.481.48
21079772-107977299.627100.46
31096524-1096524101.172102.01
41106382-1106382102.082102.92
51109807-1109807102.398103.25
61068725-106872598.60799.43
极限11080521-108052199.696100.451.46100.70101.451.46
21077203-107720399.390100.38
31094405-1094405100.977101.98
41104756-1104756101.932102.94
51107143-1107143102.152103.18
61067948-106794898.53699.52
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%
117.279455589452199451739442929452479450980.06
217.239429679423469426560.05
单位质量响应值RSD%判断
54724.8454710.160.02数据可信
供试品溶液-2024052111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%
5min11090365-1090365100.90098.362.97100.9098.362.97
21026916-102691695.02995.03
31037286-103728695.98995.99
41069756-106975698.99398.99
51106908-1106908102.431102.43
61046021-104602196.79796.80
10min11099594-1099594101.754101.171.57101.92101.331.57
21082287-1082287100.153100.31
31075560-107556099.53099.69
41078862-107886299.836100.00
51119057-1119057103.556103.73
61104264-1104264102.187102.35
15min11098725-1098725101.674101.161.44102.01101.501.43
21084322-1084322100.341100.67
31074686-107468699.45099.78
41081543-1081543100.084100.42
51115960-1115960103.269103.61
61103986-1103986102.161102.49
20min11095162-1095162101.344101.021.40101.85101.521.39
21083268-1083268100.244100.74
31074429-107442999.42699.92
41080407-108040799.979100.48
51114952-1114952103.176103.69
61101809-1101809101.959102.46
30min11095608-1095608101.386100.901.43102.06101.571.43
21080102-108010299.951100.61
31072948-107294899.28999.95
41079347-107934799.881100.55
51113902-1113902103.079103.77
61099934-1099934101.786102.46
45min11092520-1092520101.100100.621.39101.94101.451.39
21077340-107734099.695100.52
31069945-106994599.01199.83
41076888-107688899.653100.48
51109297-1109297102.652103.51
61097940-1097940101.601102.44
极限11092827-1092827101.128100.421.28102.14101.421.28
21075451-107545199.520100.51
31068334-106833498.86299.85
41075987-107598799.570100.57
51104045-1104045102.166103.20
61094291-1094291101.264102.27
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%
117.279478639474779484179476439477389478280.04
217.239462359466319464330.03
单位质量响应值RSD%判断
54882.9254929.370.06数据可信
供试品溶液-8167339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%
5min1863074-86307479.59393.298.5379.5993.308.53
21079552-107955299.55799.56
31074700-107470099.10999.11
4962101-96210188.72588.73
51015028-101502893.60693.61
61075392-107539299.17399.17
10min11087028-1087028100.24699.791.35100.3899.941.36
21098383-1098383101.293101.46
31090894-1090894100.603100.77
41069557-106955798.63598.78
51059381-105938197.69697.85
61087021-1087021100.245100.41
15min11091807-1091807100.68799.931.34100.99100.251.34
21099092-1099092101.359101.69
31090295-1090295100.547100.88
41076737-107673799.29799.61
51058242-105824297.59197.91
61085487-1085487100.104100.44
20min11091951-1091951100.70099.761.33101.17100.251.34
21094137-1094137100.902101.41
31089621-1089621100.485100.99
41076195-107619599.24799.72
51055638-105563897.35197.83
61083248-108324899.897100.40
30min11091552-1091552100.66399.651.35101.30100.311.35
21093863-1093863100.876101.55
31086613-1086613100.208100.88
41075793-107579399.21099.85
51054192-105419297.21897.86
61081580-108158099.744100.41
45min11089401-1089401100.46599.491.33101.27100.311.33
21091885-1091885100.694101.53
31083977-108397799.965100.80
41074381-107438199.08099.89
51052599-105259997.07197.88
61080813-108081399.673100.50
极限11087070-1087070100.25099.531.38101.22100.521.37
21089388-1089388100.464101.47
31084070-108407099.973100.97
41085415-1085415100.097101.07
51049761-104976196.80997.78
61079811-107981199.581100.58
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%
117.279441579436339454719453929452399447780.09
217.239422639443539433080.16
单位质量响应值RSD%判断
54706.3154748.000.06数据可信
供试品溶液-8167339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%
5min11037629-103762996.00394.797.0296.0094.797.02
21039637-103963796.18996.19
3897994-89799483.08483.08
4993875-99387591.95591.96
51097948-1097948101.584101.58
61080317-108031799.95399.95
10min11050443-105044397.189100.222.5297.35100.382.51
21052820-105282097.40997.57
31111528-1111528102.841102.98
41077011-107701199.64799.80
51107333-1107333102.453102.62
61100262-1100262101.798101.96
15min11050698-105069897.213100.833.2697.53101.153.25
21052999-105299997.42597.75
31145195-1145195105.956106.27
41085095-1085095100.395100.71
51104303-1104303102.172102.51
61100376-1100376101.809102.15
20min11047162-104716296.885100.673.3197.37101.163.29
21052466-105246697.37697.86
31144441-1144441105.886106.37
41083763-1083763100.272100.76
51103319-1103319102.081102.59
61097352-1097352101.529102.04
30min11044416-104441696.631100.393.2697.28101.053.25
21049931-104993197.14297.79
31141608-1141608105.624106.29
41087227-1087227100.592101.25
51094151-1094151101.233101.91
61092959-1092959101.123101.80
45min11041914-104191496.400100.273.3797.21101.103.36
21044474-104447496.63797.45
31138622-1138622105.347106.19
41083718-1083718100.268101.09
51098394-1098394101.626102.47
61095314-1095314101.341102.18
极限11040960-104096096.312100.093.3097.28101.093.29
21045097-104509796.69497.66
31136799-1136799105.179106.19
41080266-108026699.948100.94
51096767-1096767101.475102.49
61091045-1091045100.946101.96
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