缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
114.112488092484372485652484832487722486130.07
214.042503662503212503440.02
单位质量响应值RSD%判断
17619.6317830.770.85数据可信
供试品溶液-2批-氨氯地平-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%
5min194122-9412234.42436.844.3034.4236.844.31
299637-9963736.44136.44
399751-9975136.48336.48
4105462-10546238.57138.57
599702-9970236.46536.46
6105680-10568038.65138.65
10min1171867-17186762.85863.761.9062.9263.821.90
2171075-17107562.56862.63
3171635-17163562.77362.83
4179025-17902565.47665.54
5175461-17546164.17264.23
6176999-17699964.73564.80
15min1199796-19979673.07373.822.3873.2373.992.38
2197525-19752572.24272.41
3195692-19569271.57271.74
4206739-20673975.61275.79
5206248-20624875.43275.60
6205098-20509875.01275.18
20min1210080-21008076.83477.632.4577.1277.922.45
2206711-20671175.60275.89
3206923-20692375.67975.96
4217816-21781679.66379.96
5213556-21355678.10578.40
6218406-21840679.87980.18
30min1222979-22297981.55182.631.3781.9683.051.37
2221895-22189581.15581.57
3225184-22518482.35882.77
4229609-22960983.97684.41
5227809-22780983.31883.74
6228154-22815483.44483.87
45min1231234-23123484.57185.361.4585.1285.921.45
2230424-23042484.27484.82
3232588-23258885.06685.61
4239874-23987487.73188.30
5232562-23256285.05685.62
6233667-23366785.46086.03
60min1233572-23357285.42686.040.8086.1186.740.81
2232575-23257585.06185.75
3235642-23564286.18386.87
4237832-23783286.98487.70
5235957-23595786.29887.00
6235886-23588686.27286.98
极限1253828-25382892.83493.901.9093.6794.751.89
2248804-24880490.99791.83
3256199-25619993.70194.53
4260120-26012095.13596.00
5261777-26177795.74196.59
6259801-25980195.01995.87
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.509280285926640292661819277117928239792744760.09
215.619330256932185693260560.07
单位质量响应值RSD%判断
598353.29597441.130.11数据可信
供试品溶液-2批-缬沙坦-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%
5min17904519-790451973.69676.753.2373.7076.753.23
28008751-800875174.66874.67
38214362-821436276.58576.59
48598138-859813880.16380.16
58189827-818982776.35676.36
68474479-847447979.01079.01
10min19331768-933176887.00388.081.8287.1388.201.82
29209955-920995585.86785.99
39422138-942213887.84587.97
49647290-964729089.94590.08
59432988-943298887.94788.07
69636496-963649689.84489.98
15min19526113-952611388.81589.401.6389.0889.671.63
29351047-935104787.18387.45
39563595-956359589.16489.44
49770286-977028691.09191.37
59567517-956751789.20189.47
69751649-975164990.91891.20
20min19579475-957947589.31289.751.5589.7390.181.55
29395689-939568987.59988.01
39613250-961325089.62790.05
49800605-980060591.37491.81
59592957-959295789.43889.86
69778748-977874891.17091.60
30min19666589-966658990.12590.341.3590.6990.921.35
29478192-947819288.36888.93
39696728-969672890.40690.98
49854444-985444491.87692.46
59650297-965029789.97390.54
69794964-979496491.32191.91
45min19758907-975890790.98590.921.2191.7091.651.21
29556631-955663189.09989.81
39758680-975868090.98391.71
49908741-990874192.38293.12
59709560-970956090.52591.25
69821281-982128191.56792.30
60min19800186-980018691.37091.281.2592.2492.151.26
29593882-959388289.44790.30
39788826-978882691.26492.14
49965423-996542392.91193.81
59745167-974516790.85791.73
69847500-984750091.81192.70
极限110245918-1024591895.52694.961.0296.5495.991.02
210008889-1000888993.31694.32
310134778-1013477894.49095.52
410285079-1028507995.89196.94
510264529-1026452995.69996.72
610174022-1017402294.85695.90
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