左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.341877851878521876771878451877511877820.04
217.421873411878821876120.21
单位质量响应值RSD%判断
10829.4110769.920.39数据可信
供试品溶液-24082901批-左氨氯地平-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1106480-10648099.60399.550.8899.6099.550.87
2105096-10509698.30898.31
3106238-10623899.37699.38
4105820-10582098.98598.99
5107454-107454100.514100.51
6107453-107453100.513100.51
10min1107139-107139100.21999.550.97101.33100.660.96
2105673-10567398.84899.94
3106853-10685399.952101.06
4105212-10521298.41799.52
5105803-10580398.970100.09
6107885-107885100.917102.03
15min1105617-10561798.79698.850.94101.02101.070.93
2104235-10423597.50399.69
3106099-10609999.246101.46
4104908-10490898.132100.33
5106243-10624399.381101.60
6106976-106976100.067102.30
20min1103649-10364996.95597.511.14100.27100.821.13
2103296-10329696.62499.90
3104853-10485398.081101.40
4102751-10275196.11599.40
5105085-10508598.298101.62
6105807-10580798.973102.32
30min1103456-10345696.77496.930.81101.17101.330.82
2102644-10264496.015100.36
3104058-10405897.337101.74
4102954-10295496.305100.66
5103637-10363796.943101.36
6105002-10500298.220102.67
45min1102062-10206295.47095.740.57100.94101.210.57
2101803-10180395.228100.64
3103192-10319296.527102.02
4101768-10176895.195100.62
5102824-10282496.183101.67
6102440-10244095.824101.36
60min1101276-10127694.73594.210.75101.27100.740.75
299877-9987793.42699.90
3101313-10131394.770101.33
499671-9967193.23499.71
5100883-10088394.367100.93
6101262-10126294.722101.33
90min199474-9947493.04992.990.83100.63100.570.83
298422-9842292.06599.58
399815-9981593.368100.98
498439-9843992.08199.60
599819-9981993.372100.98
6100474-10047493.985101.64
极限199118-9911892.71691.800.89101.33100.410.87
296896-9689690.63899.17
398038-9803891.706100.36
497364-9736491.07699.61
598571-9857192.205100.85
698815-9881592.433101.14
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.101960511962331959411961141957751960230.09
216.181955561957031956300.06
单位质量响应值RSD%判断
12175.3412090.850.50数据可信
供试品溶液-24082901批-叶酸-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min129623-2962325.05024.4411.6425.0524.4411.64
223317-2331719.71819.72
332051-3205127.10327.10
432024-3202427.08027.08
526748-2674822.61922.62
629661-2966125.08225.08
10min154149-5414945.79044.358.7846.0744.628.80
244823-4482337.90438.12
357294-5729448.45048.75
456214-5621447.53647.84
549767-4976742.08542.34
652437-5243744.34244.62
15min166601-6660156.32054.627.4557.1155.397.48
256513-5651347.78948.43
368887-6888758.25359.09
469400-6940058.68759.52
562844-6284453.14353.86
663328-6332853.55254.32
20min173257-7325761.94859.917.2163.3661.287.24
261808-6180852.26753.44
375353-7535363.72165.21
475271-7527163.65165.13
569492-6949258.76560.07
669874-6987459.08860.45
30min180269-8026967.87865.966.9269.9868.006.96
268441-6844157.87659.63
382188-8218869.50171.70
483341-8334170.47672.66
576363-7636364.57566.54
677423-7742365.47167.49
45min184300-8430071.28771.347.6974.1474.117.69
273790-7379062.39964.79
392115-9211577.89580.86
490142-9014276.22779.20
582308-8230869.60272.28
683551-8355170.65373.40
60min186949-8694973.52774.008.5777.1777.568.52
275730-7573064.04067.13
397724-9772482.63886.47
492447-9244778.17681.99
583964-8396471.00374.46
688203-8820374.58778.12
90min188555-8855574.88576.709.0879.3581.088.98
278389-7838966.28870.09
3102065-10206586.30991.06
495175-9517580.48385.17
585993-8599372.71876.96
694013-9401379.50083.86
极限196623-9662381.70782.835.1887.0088.065.32
289365-8936575.57080.11
3103928-10392887.88593.59
4100618-10061885.08690.67
596419-9641981.53586.59
6100734-10073485.18490.43
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