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%
117.279548539548109515479498769481089518390.32
217.239486869480119483480.06
单位质量响应值RSD%判断
55115.1755040.510.10数据可信
供试品溶液-2024052111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%
5min11017942-101794293.58291.677.0293.5891.677.02
21037734-103773495.40295.40
3857610-85761078.84378.84
41036480-103648095.28795.29
51034106-103410695.06895.07
6998948-99894891.83691.84
10min11069916-106991698.36098.491.0298.5298.651.02
21071985-107198598.55198.71
31072950-107295098.63998.77
41078094-107809499.11299.27
51083586-108358699.61799.78
61051691-105169196.68596.84
15min11086804-108680499.91399.571.08100.2399.891.08
21068071-106807198.19198.51
31087534-108753499.980100.28
41090722-1090722100.273100.60
51096028-1096028100.761101.09
61069357-106935798.30998.62
20min11095693-1095693100.730100.261.13101.22100.741.13
21072691-107269198.61699.10
31093011-1093011100.484100.95
41100504-1100504101.172101.66
51103023-1103023101.404101.90
61078326-107832699.13499.61
30min11098096-1098096100.951100.441.27101.61101.091.27
21075035-107503598.83199.48
31094547-1094547100.625101.25
41100784-1100784101.198101.86
51109685-1109685102.017102.68
61076787-107678798.99299.64
45min11095827-1095827100.742100.351.22101.57101.171.22
21073732-107373298.71199.53
31094136-1094136100.587101.38
41104409-1104409101.531102.36
51104343-1104343101.525102.36
61076908-107690899.00399.81
极限11093639-1093639100.54199.931.19101.53100.921.19
21070601-107060198.42399.40
31088130-1088130100.035101.00
41095096-1095096100.675101.67
51102460-1102460101.352102.35
61072276-107227698.57799.55
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%
117.279498139486199481889489429480849487290.08
217.239472769478889475820.05
单位质量响应值RSD%判断
54935.0954996.050.08数据可信
供试品溶液-2024052111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%
5min11041751-104175195.96793.772.1495.9793.772.14
21025886-102588694.50594.51
3978359-97835990.12790.13
41027907-102790794.69194.69
51010755-101075593.11193.11
61022809-102280994.22294.22
10min11077036-107703699.21797.920.9799.3898.080.98
21071290-107129098.68898.85
31047897-104789796.53396.68
41061363-106136397.77397.93
51057413-105741397.41097.56
61063057-106305797.92998.09
15min11088534-1088534100.27699.260.73100.6099.580.73
21082566-108256699.727100.05
31065539-106553998.15898.47
41074804-107480499.01299.33
51075057-107505799.03599.35
61078479-107847999.35099.67
20min11092479-1092479100.64099.920.78101.13100.410.78
21090048-1090048100.416100.90
31070218-107021898.58999.06
41079798-107979899.47299.96
51085586-1085586100.005100.49
61090073-1090073100.418100.90
30min11098157-1098157101.163100.220.65101.82100.870.65
21090886-1090886100.493101.15
31076878-107687899.20399.84
41085195-108519599.969100.62
51086843-1086843100.121100.77
61089411-1089411100.357101.01
45min11095206-1095206100.891100.050.72101.72100.860.72
21091294-1091294100.531101.35
31072959-107295998.84299.65
41081949-108194999.670100.49
51086810-1086810100.118100.93
61088045-1088045100.231101.05
极限11093884-1093884100.76999.810.75101.77100.800.75
21085613-1085613100.007101.00
31069595-106959598.53299.50
41081861-108186199.662100.65
51082354-108235499.707100.69
61087442-1087442100.176101.16
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%
117.279517379485139508989488739481249496290.17
217.239498849497549498190.01
单位质量响应值RSD%判断
54987.2055125.890.18数据可信
供试品溶液-8167339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%
5min11043147-104314795.93794.253.1695.9494.253.15
21069414-106941498.35298.35
3996726-99672691.66791.67
4985252-98525290.61290.61
51010868-101086892.96892.97
61043193-104319395.94195.94
10min11050399-105039996.60496.392.4296.7696.542.42
21079553-107955399.28599.45
31016882-101688293.52193.67
41025232-102523294.28994.44
51042279-104227995.85796.01
61074045-107404598.77898.94
15min11049779-104977996.54796.392.7496.8796.712.75
21078832-107883299.21999.55
31019733-101973393.78394.09
41014618-101461893.31393.62
51042724-104272495.89896.21
61082995-108299599.60199.93
20min11047425-104742596.33096.952.5396.8197.422.53
21086284-108628499.904100.40
31027082-102708294.45994.92
41030576-103057694.78195.24
51045955-104595596.19596.67
61087535-1087535100.019100.51
30min11045682-104568296.17096.852.7296.8197.492.72
21083839-108383999.679100.34
31015654-101565493.40894.03
41036412-103641295.31795.94
51046555-104655596.25096.88
61090225-1090225100.266100.92
45min11052297-105229796.77897.202.5897.5898.002.59
21088108-1088108100.072100.90
31022357-102235794.02594.80
41037545-103754595.42196.20
51050569-105056996.61997.41
61090275-1090275100.271101.10
极限11068727-106872798.28997.822.2999.2598.782.29
21093203-1093203100.540101.53
31038588-103858895.51796.45
41037906-103790695.45596.39
51054041-105404196.93997.89
61089351-1089351100.186101.18
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%
117.279553199573899556989567879564069563200.09
217.239477599477729477660.01
单位质量响应值RSD%判断
55374.6455006.730.48数据可信
供试品溶液-8167339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%
5min11058047-105804797.07191.4210.2597.0791.4110.25
21007825-100782592.46492.46
3791308-79130872.59972.60
41054809-105480996.77496.77
51034861-103486194.94494.94
61031567-103156794.64294.64
10min11068409-106840998.02295.943.3198.1896.093.32
21050059-105005996.33996.49
3976322-97632289.57389.69
41063195-106319597.54497.71
51057810-105781097.05097.21
61058638-105863897.12697.28
15min11069881-106988198.15796.981.4598.4897.291.46
21050790-105079096.40696.72
31029574-102957494.45994.73
41062722-106272297.50097.82
51059181-105918197.17597.50
61069863-106986398.15598.48
20min11063906-106390697.60997.291.1198.1097.761.12
21050254-105025496.35696.83
31042614-104261495.65696.08
41063998-106399897.61798.10
51067747-106774797.96198.44
61074040-107404098.53999.02
30min11062011-106201197.43597.270.8098.0997.900.82
21056591-105659196.93897.57
31046640-104664096.02596.61
41061211-106121197.36298.01
51062430-106243097.47498.12
61072380-107238098.38699.03
45min11063464-106346497.56897.301.0098.3898.101.01
21051646-105164696.48497.28
31048013-104801396.15196.90
41065240-106524097.73198.54
51057648-105764897.03597.84
61077275-107727598.83699.65
极限11080404-108040499.12398.380.96100.1099.340.96
21068836-106883698.06199.02
31064932-106493297.70398.61
41084990-108499099.543100.52
51057926-105792697.06098.03
61077041-107704198.81499.79
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