盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.073837633835963839453836563838523837620.04
212.153828023821263824640.13
单位质量响应值RSD%判断
31794.7031478.520.71数据可信
供试品溶液-2023120221批-0.1mol/L盐酸溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1393085-39308594.18190.983.5394.1890.983.53
2387575-38757592.86092.86
3375091-37509189.86989.87
4355583-35558385.19585.20
5380256-38025691.10791.11
6386838-38683892.68492.68
5min1427407-427407102.40499.682.32102.4099.682.32
2418691-418691100.316100.32
3404965-40496597.02797.03
4408195-40819597.80197.80
5410411-41041198.33298.33
6426583-426583102.207102.21
10min1427593-427593102.44999.832.17102.4599.832.17
2418607-418607100.296100.30
3406328-40632897.35497.35
4408693-40869397.92097.92
5412307-41230798.78698.79
6426395-426395102.161102.16
15min1426667-426667102.22799.692.38102.2399.692.38
2420273-420273100.695100.69
3403897-40389796.77196.77
4408357-40835797.84097.84
5410352-41035298.31898.32
6426850-426850102.270102.27
20min1424938-424938101.812100.201.75101.81100.201.75
2418355-418355100.235100.24
3406335-40633597.35597.36
4413331-41333199.03199.03
5421108-421108100.895100.89
6425131-425131101.859101.86
30min1428047-428047102.55799.932.14102.5699.932.14
2420233-420233100.685100.69
3406937-40693797.49997.50
4408331-40833197.83397.83
5413225-41322599.00699.01
6425635-425635101.979101.98
45min1427207-427207102.356100.082.19102.36100.082.19
2420009-420009100.631100.63
3407442-40744297.62097.62
4409190-40919098.03998.04
5413489-41348999.06999.07
6428859-428859102.752102.75
极限1427166-427166102.346100.032.14102.35100.032.14
2420018-420018100.634100.63
3405980-40598097.27097.27
4409761-40976198.17698.18
5414670-41467099.35299.35
6427375-427375102.396102.40
盐酸伐地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号2.0对照品来源中检院对照品使用方法直接使用
对照品含量(%)90.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.073825573826123827373826543824783826080.03
212.153827133822763824940.09
单位质量响应值RSD%判断
31699.0931480.990.49数据可信
供试品溶液-2023120221批-0.1mol/L盐酸溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min1130662-13066231.35230.4220.6431.3530.4220.63
2128355-12835530.79830.80
390552-9055221.72721.73
4139574-13957433.49033.49
5106042-10604225.44425.44
6165461-16546139.70139.70
5min1218502-21850252.42855.5114.4252.4355.5114.42
2241042-24104257.83657.84
3177582-17758242.61042.61
4250576-25057660.12460.12
5224395-22439553.84253.84
6275981-27598166.22066.22
10min1282568-28256867.80071.307.5067.8071.307.50
2308132-30813273.93473.93
3260778-26077862.57262.57
4312242-31224274.92074.92
5297736-29773671.44071.44
6321593-32159377.16477.16
15min1320509-32050976.90479.633.5776.9079.633.57
2339632-33963281.49381.49
3313954-31395475.33175.33
4341365-34136581.90881.91
5334265-33426580.20580.20
6341474-34147481.93481.93
20min1345701-34570182.94984.931.9482.9584.931.94
2359377-35937786.23086.23
3344675-34467582.70382.70
4359103-35910386.16486.16
5357352-35735285.74485.74
6357562-35756285.79585.79
30min1373445-37344589.60690.941.4789.6190.941.47
2388174-38817493.14093.14
3380195-38019591.22591.23
4378212-37821290.75090.75
5380753-38075391.35991.36
6373201-37320189.54789.55
45min1392291-39229194.12895.411.7094.1395.411.70
2404450-40445097.04597.05
3405682-40568297.34197.34
4395651-39565194.93494.93
5399027-39902795.74495.74
6388646-38864693.25393.25
极限1412730-41273099.032100.212.2599.03100.212.25
2429937-429937103.161103.16
3429013-429013102.939102.94
4414315-41431599.41299.41
5411423-41142398.71898.72
6408394-40839497.99297.99
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