苯磺酸左氨氯地平缬沙坦片项目信息
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100374-202105对照品来源中检院对照品使用方法分装
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.962397772397092394912394582394952395860.07
214.052387032387282387160.01
单位质量响应值RSD%判断
17162.3216990.460.72数据可信
供试品溶液-8170102批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min160568-6056822.39521.025.1222.3921.025.10
255221-5522120.41820.42
357396-5739621.22221.22
459446-5944621.98021.98
555735-5573520.60820.61
652674-5267419.47619.48
10min1114719-11471942.41742.925.4942.4542.965.49
2112910-11291041.74841.78
3116836-11683643.20043.24
4126652-12665246.82946.87
5117983-11798343.62443.66
6107432-10743239.72339.76
15min1140450-14045051.93153.004.2652.0453.104.25
2140244-14024451.85551.96
3140226-14022651.84851.96
4155284-15528457.41657.53
5144263-14426353.34153.45
6139539-13953951.59451.69
20min1152067-15206756.22658.584.2256.4258.784.22
2156115-15611557.72357.91
3157107-15710758.09058.28
4170562-17056263.06563.28
5161001-16100159.53059.73
6153798-15379856.86657.05
30min1175624-17562464.93766.483.5165.2266.773.51
2176639-17663965.31265.60
3179107-17910766.22466.52
4192346-19234671.11971.43
5178807-17880766.11366.41
6176238-17623865.16465.44
45min1197106-19710672.87974.003.4573.2874.403.46
2196753-19675372.74973.14
3198361-19836173.34473.74
4214182-21418279.19379.63
5197419-19741972.99573.40
6197004-19700472.84273.23
60min1206950-20695076.51978.012.4777.0478.542.47
2209855-20985577.59378.11
3209026-20902677.28777.81
4221358-22135881.84782.41
5209969-20996977.63678.16
6208765-20876577.19077.70
极限1243806-24380690.14793.942.6590.7994.592.65
2251283-25128392.91193.56
3257709-25770995.28795.94
4262639-26263997.11097.81
5258002-25800295.39696.05
6250910-25091092.77393.41
苯磺酸左氨氯地平缬沙坦片项目信息
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100374-202105对照品来源中检院对照品使用方法分装
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.962403612404152406392406422405632405240.06
214.052401002398802399900.07
单位质量响应值RSD%判断
17229.5117081.140.62数据可信
供试品溶液-8170102批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min154363-5436320.00821.838.9620.0121.838.96
255015-5501520.24820.25
367792-6779224.95024.95
461094-6109422.48522.49
562138-6213822.87022.87
655431-5543120.40120.40
10min1122376-12237645.04046.916.2745.0746.946.28
2121065-12106544.55744.59
3142559-14255952.46852.51
4123433-12343345.42945.47
5129663-12966347.72247.76
6125610-12561046.23046.26
15min1154767-15476756.96157.704.6357.0757.824.63
2153830-15383056.61656.72
3170427-17042762.72562.85
4149498-14949855.02255.14
5158310-15831058.26558.38
6153876-15387656.63356.74
20min1171881-17188163.26063.764.5163.4663.974.51
2169518-16951862.39062.59
3188860-18886069.50969.74
4167576-16757661.67561.88
5171549-17154963.13863.35
6170085-17008562.59962.80
30min1195235-19523571.85571.564.3072.1671.884.30
2192446-19244670.82971.13
3210571-21057177.49977.85
4187425-18742568.98169.29
5191655-19165570.53770.86
6189271-18927169.66069.97
45min1206302-20630275.92877.623.5276.3678.053.53
2211742-21174277.93078.35
3225028-22502882.82083.30
4204610-20461075.30575.73
5210506-21050677.47577.91
6207143-20714376.23876.66
60min1219807-21980780.89981.622.7281.4582.182.73
2224669-22466982.68883.24
3232513-23251385.57586.19
4216137-21613779.54880.10
5220001-22000180.97081.54
6217410-21741080.01680.57
极限1256777-25677794.50595.452.5995.2096.162.58
2264510-26451097.35198.04
3267030-26703098.27999.04
4261994-26199496.42597.11
5248315-24831591.39192.09
6257473-25747394.76195.45
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