坎地沙坦酯氢氯噻嗪片项目信息
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8000
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%
113.834319543255432414333443265432580.12
213.834355343512435320.07
单位质量响应值RSD%判断
3127.843147.650.45数据可信
加速1月-供试品溶液-2024042711批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min145209-4520990.97187.843.6890.9787.843.67
244842-4484290.23290.23
343450-4345087.43187.43
443732-4373287.99988.00
543998-4399888.53488.53
640679-4067981.85581.86
10min145639-4563991.83691.820.6592.8592.800.64
245233-4523391.01992.02
345971-4597192.50493.48
445407-4540791.36992.35
545951-4595192.46493.45
645599-4559991.75692.67
15min144737-4473790.02190.980.6292.0592.980.60
245157-4515790.86692.88
345583-4558391.72393.72
445251-4525191.05593.05
545358-4535891.27193.28
645198-4519890.94992.88
20min143568-4356887.66989.041.5090.7092.051.43
244069-4406988.67791.70
344065-4406588.66991.69
443677-4367787.88890.89
544985-4498590.52093.55
645142-4514290.83693.78
30min143021-4302186.56888.281.5190.5792.281.45
244034-4403488.60692.62
343751-4375188.03792.04
443257-4325787.04391.02
544642-4464289.83093.86
644536-4453689.61793.57
45min142723-4272385.96887.141.1790.9492.121.11
242923-4292386.37191.36
343229-4322986.98791.97
443152-4315286.83291.78
544012-4401288.56293.59
643807-4380788.15093.09
60min142532-4253285.58486.391.0091.5192.340.94
243072-4307286.67192.62
342579-4257985.67991.63
442701-4270185.92491.84
543041-4304186.60892.62
643675-4367587.88493.81
极限141944-4194484.40184.660.8491.2791.570.78
241672-4167283.85490.77
342446-4244685.41192.31
441760-4176084.03190.90
542111-4211184.73791.71
642515-4251585.55092.45
坎地沙坦酯氢氯噻嗪片项目信息
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8000
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%
113.834308643074430454299543057430510.09
213.834335643345433500.02
单位质量响应值RSD%判断
3112.873134.490.49数据可信
加速1月-供试品溶液-2024042711批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min143105-4310587.12886.815.7187.1386.805.71
244187-4418789.31589.31
342459-4245985.82285.82
446316-4631693.61893.62
542757-4275786.42486.42
638851-3885178.52978.53
10min146127-4612793.23690.444.2094.2091.414.12
245069-4506991.09892.09
346347-4634793.68194.63
441142-4114283.16084.20
545001-4500190.96091.92
644790-4479090.53491.41
15min144828-4482890.61190.030.9492.6192.000.93
244033-4403389.00491.01
344897-4489790.75092.74
444126-4412689.19291.16
544984-4498490.92692.90
644384-4438489.71391.59
20min145028-4502891.01589.451.0994.0392.421.09
243759-4375988.45091.44
344649-4464990.24993.25
444078-4407889.09592.05
544048-4404889.03492.02
643956-4395688.84891.72
30min144137-4413789.21488.312.1193.2492.272.04
243704-4370488.33992.31
344726-4472690.40494.41
441984-4198484.86288.81
543732-4373288.39592.37
643843-4384388.62092.48
45min143883-4388388.70087.720.9893.7192.660.97
242795-4279586.50191.46
343828-4382888.58993.60
443428-4342887.78192.67
543372-4337287.66892.62
643080-4308087.07791.92
60min142939-4293986.79286.470.7892.7992.390.77
242291-4229185.48291.40
343050-4305087.01793.01
442881-4288186.67592.54
543074-4307487.06592.99
642450-4245085.80491.62
极限142364-4236485.63084.841.2092.5991.721.18
242331-4233185.56392.43
342578-4257886.06393.02
441495-4149583.87490.70
541614-4161484.11491.01
641466-4146683.81590.58
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