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%
117.61 9620029621819621869620659612919619450.04
217.639550169556519553340.05
单位质量响应值RSD%判断
54624.9354187.980.57数据可信
加速3月-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%
5min1991525-99152592.28092.231.1392.2892.231.13
2986390-98639091.80291.80
3972700-97270090.52890.53
4990788-99078892.21192.21
51005171-100517193.55093.55
6999345-99934593.00893.01
10min11057530-105753098.42397.491.4698.5897.641.45
21032756-103275696.11796.27
31029740-102974095.83795.99
41057502-105750298.42098.57
51040529-104052996.84197.00
61066781-106678199.28499.44
15min11081260-1081260100.63299.291.22100.9599.601.22
21050410-105041097.76098.07
31051497-105149797.86298.17
41075354-1075354100.082100.40
51068117-106811799.40899.73
61074127-107412799.968100.29
20min11090027-1090027101.44799.961.17101.93100.441.17
21059686-105968698.62499.10
31061140-106114098.75999.23
41081323-1081323100.637101.12
51069113-106911399.50199.98
61083236-1083236100.815101.30
30min11097380-1097380102.132100.511.08102.79101.161.08
21065374-106537499.15399.79
31070265-107026599.608100.25
41084886-1084886100.969101.62
51076864-1076864100.222100.87
61085067-1085067100.986101.64
45min11097749-1097749102.166100.660.96102.99101.470.96
21068950-106895099.486100.29
31071907-107190799.761100.57
41084626-1084626100.945101.77
51081647-1081647100.668101.48
61084242-1084242100.909101.73
极限11096191-1096191102.021100.581.13103.02101.561.12
21062401-106240198.87699.85
31074110-107411099.966100.94
41082092-1082092100.709101.70
51078335-1078335100.359101.34
61091052-1091052101.543102.53
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%
117.61 9571369565699561669574149569519568470.06
217.639565329550279557800.12
单位质量响应值RSD%判断
54335.4354213.270.16数据可信
加速3月-供试品溶液-2024052011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%
5min1974321-97432190.89889.893.2890.9089.893.28
2944408-94440888.10888.11
3921511-92151185.97185.97
4947753-94775388.42088.42
51008530-100853094.09094.09
6984739-98473991.87091.87
10min11037479-103747996.79095.982.7496.9496.122.74
2999556-99955693.25293.40
3993185-99318592.65892.80
41031266-103126696.21196.36
51068373-106837399.67399.83
61042586-104258697.26797.42
15min11053360-105336098.27297.841.9298.5898.151.92
21022505-102250595.39395.70
31027208-102720895.83296.13
41051143-105114398.06598.37
51070107-107010799.834100.16
61068221-106822199.65999.97
20min11062046-106204699.08298.741.7099.5699.211.70
21031853-103185396.26696.73
31042145-104214597.22697.68
41062373-106237399.11399.58
51074615-1074615100.255100.74
61077070-1077070100.484100.97
30min11065787-106578799.43199.381.45100.07100.011.45
21041363-104136397.15397.77
31054035-105403598.33598.95
41069326-106932699.762100.40
51077636-1077636100.537101.19
61082971-1082971101.035101.68
45min11065814-106581499.43499.641.83100.24100.441.83
21042321-104232197.24298.03
31052990-105299098.23899.02
41070406-107040699.862100.66
51078688-1078688100.635101.46
61097741-1097741102.413103.23
极限11063636-106363699.23199.321.44100.20100.291.45
21041140-104114097.13298.08
31055124-105512498.43799.38
41067048-106704899.549100.52
51076652-1076652100.445101.44
61084052-1084052101.135102.12
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%
117.61 9574409551349563479547399565749560470.12
217.639594559574709584620.15
单位质量响应值RSD%判断
54290.0154365.400.10数据可信
加速3月-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%
5min1986815-98681591.97391.652.7591.9791.652.75
2980888-98088891.42191.42
3968352-96835290.25390.25
4953790-95379088.89588.90
5976972-97697291.05691.06
61033185-103318596.29596.30
10min11050489-105048997.90897.731.6598.0697.881.65
21053069-105306998.14898.30
31025791-102579195.60695.76
41067362-106736299.48199.63
51030296-103029696.02696.18
61064585-106458599.22299.38
15min11065878-106587899.34299.371.5099.6699.691.50
21068224-106822499.56199.88
31053393-105339398.17998.49
41087263-1087263101.335101.65
51043628-104362897.26897.58
61078637-1078637100.531100.86
20min11072040-107204099.917100.101.14100.40100.581.14
21074444-1074444100.141100.62
31068379-106837999.575100.05
41089740-1089740101.566102.05
51055083-105508398.33698.81
61084177-1084177101.048101.54
30min11070721-107072199.794100.691.12100.44101.341.12
21081560-1081560100.804101.45
31081642-1081642100.811101.45
41092637-1092637101.836102.49
51062709-106270999.04799.68
61093072-1093072101.877102.54
45min11070587-107058799.781100.741.08100.60101.561.08
21083846-1083846101.017101.83
31085310-1085310101.153101.96
41088269-1088269101.429102.25
51063193-106319399.09299.89
61094097-1094097101.972102.80
极限11071538-107153899.870100.651.06100.85101.641.05
21079829-1079829100.642101.63
31089512-1089512101.545102.52
41083430-1083430100.978101.97
51062467-106246799.02499.99
61092802-1092802101.852102.85
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