坎地沙坦酯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2000
标示量(mg)8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%
116.217850978516786847859278275785150.20
216.337821378190782020.03
单位质量响应值RSD%判断
4843.624788.850.81数据可信
坎地沙坦酯--供试品溶液-6041502批-pH6.8(内含0.1%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min114149-1414916.49217.8513.3916.4917.8513.39
215029-1502917.51817.52
314392-1439216.77616.78
416717-1671719.48619.49
518640-1864021.72721.73
612933-1293315.07515.08
10min138284-3828444.62544.965.5644.6544.985.57
237669-3766943.90843.94
336655-3665542.72642.75
439899-3989946.50746.54
542196-4219649.18549.22
636701-3670142.78042.80
15min151210-5121059.69260.182.8559.7960.282.86
251192-5119259.67159.77
350123-5012358.42558.52
452843-5284361.59561.71
553940-5394062.87462.99
650470-5047058.82958.93
20min159312-5931269.13669.542.1669.3469.752.17
259414-5941469.25569.46
358382-5838268.05268.25
461190-6119071.32571.54
561254-6125471.39971.62
658412-5841268.08768.28
30min168676-6867680.05180.281.7680.3780.601.77
268850-6885080.25380.57
367559-6755978.74979.06
470626-7062682.32482.66
569866-6986681.43881.78
667657-6765778.86379.17
45min175355-7535587.83687.681.0788.2988.141.08
275046-7504687.47687.93
374005-7400586.26286.70
476296-7629688.93389.40
575836-7583688.39688.87
674815-7481587.20687.65
60min178103-7810391.03991.270.6491.6491.870.65
278253-7825391.21491.81
377518-7751890.35790.94
478974-7897492.05492.67
578635-7863591.65992.28
678322-7832291.29491.88
极限180290-8029093.58893.860.6994.3494.610.70
280236-8023693.52594.27
379664-7966492.85893.59
480957-8095794.36695.14
580941-8094194.34795.12
681060-8106094.48695.22
坎地沙坦酯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2000
标示量(mg)8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%
116.217801177822779777781877706778670.17
216.337816478285782240.11
单位质量响应值RSD%判断
4803.644790.200.20数据可信
坎地沙坦酯--供试品溶液-6041502批-shui(内含0.25%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min115278-1527817.88016.976.7817.8816.966.80
215404-1540418.02718.03
314435-1443516.89316.89
413428-1342815.71515.71
513196-1319615.44315.44
615243-1524317.83917.84
10min143476-4347650.87948.0410.5350.9148.0710.54
245807-4580753.60753.64
341553-4155348.62948.66
437254-3725443.59843.62
534492-3449240.36540.39
643743-4374351.19251.22
15min158385-5838568.32764.928.6868.4465.028.68
260353-6035370.63070.75
357020-5702066.73066.84
450713-5071359.34959.45
548276-4827656.49756.59
658070-5807067.95868.07
20min165737-6573776.93174.426.2877.1674.646.29
267478-6747878.96879.21
365506-6550676.66176.88
459052-5905269.10869.31
558016-5801667.89568.08
665745-6574576.94077.17
30min173679-7367986.22584.464.1486.5884.804.15
274830-7483087.57287.94
373482-7348285.99586.34
468036-6803679.62179.93
568726-6872680.42980.73
674280-7428086.92987.29
45min178535-7853591.90890.522.3092.4191.002.32
278038-7803891.32791.84
378509-7850991.87892.37
474655-7465587.36887.81
575565-7556588.43388.87
678796-7879692.21492.72
60min180917-8091794.69693.731.6495.3594.361.66
279727-7972793.30393.97
381149-8114994.96795.61
478459-7845991.81992.41
578729-7872992.13592.72
681562-8156295.45196.11
极限181595-8159595.48994.921.0496.3095.701.06
281068-8106894.87395.69
381764-8176495.68796.49
479906-7990693.51394.26
580321-8032193.99894.73
681983-8198395.94396.76
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