坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)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%
116.081764201761661760171763811766691763310.15
216.121751701759461755580.32
单位质量响应值RSD%判断
10965.8610890.690.49数据可信
供试品溶液-2024042711批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min171607-7160736.78436.795.5036.7836.795.50
269235-6923535.56635.57
365992-6599233.90033.90
473935-7393537.98037.98
577509-7750939.81639.82
671418-7141836.68736.69
10min1124760-12476064.08964.592.0364.5065.002.05
2124036-12403663.71764.11
3121969-12196962.65563.03
4127804-12780465.65266.07
5128447-12844765.98366.43
6127380-12738065.43565.84
15min1150046-15004677.07877.581.5078.2078.701.53
2149563-14956376.83077.93
3148588-14858876.32977.40
4151765-15176577.96179.11
5155024-15502479.63580.81
6151144-15114477.64278.78
20min1164355-16435584.42984.490.6186.4186.480.65
2164220-16422084.35986.32
3163229-16322983.85085.77
4164676-16467684.59386.61
5166251-16625185.40387.46
6164069-16406984.28286.28
30min1174806-17480689.79789.521.4492.7192.441.44
2172025-17202588.36991.26
3170627-17062787.65090.50
4177451-17745191.15694.11
5175118-17511889.95792.97
6175565-17556590.18793.12
45min1179339-17933992.12691.321.3596.0495.241.34
2176750-17675090.79694.67
3173941-17394189.35393.18
4180736-18073692.84396.81
5177094-17709490.97394.98
6178790-17879091.84495.78
60min1178505-17850591.69791.910.8196.6396.840.84
2178092-17809291.48596.37
3176852-17685290.84895.67
4180917-18091792.93697.94
5180027-18002792.47997.50
6179084-17908491.99596.95
极限1179603-17960392.26190.841.3198.2296.801.30
2174807-17480789.79895.70
3173724-17372489.24195.07
4177701-17770191.28497.32
5178866-17886691.88397.93
6176370-17637090.60196.58
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)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%
116.081752041754301755851757481752621754460.13
216.121752971756891754930.16
单位质量响应值RSD%判断
10910.8210886.660.16数据可信
供试品溶液-2024042711批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187306-8730644.97036.0419.2044.9736.0419.20
279184-7918440.78640.79
367279-6727934.65434.65
463130-6313032.51732.52
548860-4886025.16725.17
674019-7401938.12638.13
10min1127949-12794965.90458.948.3666.4059.348.42
2123938-12393863.83864.29
3113221-11322158.31858.70
4105440-10544054.31054.67
5104866-10486654.01554.29
6111199-11119957.27757.70
15min1157724-15772481.24175.784.9282.4776.835.01
2154375-15437579.51680.68
3145493-14549374.94175.97
4143463-14346373.89574.86
5140103-14010372.16573.04
6141515-14151572.89273.95
20min1168367-16836786.72382.833.5188.8684.733.55
2163815-16381584.37886.42
3162058-16205883.47385.34
4159210-15921082.00683.79
5159994-15999482.41084.09
6151435-15143578.00279.87
30min1178053-17805391.71289.822.3294.8192.642.33
2175083-17508390.18293.17
3175540-17554090.41893.21
4174258-17425889.75792.45
5176785-17678591.05993.66
6166604-16660485.81588.55
45min1183844-18384494.69591.712.4398.8195.522.47
2176988-17698891.16495.15
3178682-17868292.03695.83
4181860-18186093.67397.37
5172640-17264088.92492.53
6174239-17423989.74893.44
60min1179817-17981792.62191.561.2197.7996.401.17
2176073-17607390.69295.69
3174708-17470889.98994.81
4177431-17743191.39296.13
5178283-17828391.83196.43
6180221-18022192.82997.52
极限1176512-17651290.91891.090.5197.1296.950.43
2176281-17628190.79996.81
3176363-17636390.84296.66
4176130-17613090.72296.47
5177381-17738191.36696.98
6178456-17845691.92097.64
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