坎地沙坦酯片项目信息
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对照品来源中检所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%
115.987470175092753497472174856749440.37
216.077514475020750820.12
单位质量响应值RSD%判断
4689.864672.180.27数据可信
供试品溶液-12412515批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110722-1072212.8587.6538.6212.867.6638.59
26517-65177.8167.82
34675-46755.6075.61
46108-61087.3257.33
56770-67708.1198.12
63490-34904.1854.19
10min132413-3241338.87226.5725.7838.8926.5825.78
222661-2266127.17627.19
316657-1665719.97619.99
422015-2201526.40226.41
522260-2226026.69626.71
616932-1693220.30620.31
15min154298-5429865.11748.1120.3965.2048.1720.39
241134-4113449.33049.39
329915-2991535.87635.92
441500-4150049.76949.83
538632-3863246.33046.39
635223-3522342.24242.28
20min168399-6839982.02866.7415.5982.2266.8815.60
258456-5845670.10470.24
341998-4199850.36750.47
458325-5832569.94770.09
554358-5435865.18965.32
652380-5238062.81762.93
30min180152-8015296.12388.049.8296.4588.299.84
276974-7697492.31292.57
359655-5965571.54271.73
476918-7691892.24592.50
573627-7362788.29888.54
673158-7315887.73687.95
45min183982-83982100.71697.617.16101.2198.007.18
283944-83944100.671101.08
369519-6951983.37183.68
484132-84132100.896101.31
583479-83479100.113100.50
683288-8328899.884100.25
60min183970-83970100.70298.646.29101.3699.196.31
284321-84321101.123101.70
371708-7170885.99786.44
484805-84805101.703102.28
584259-84259101.049101.61
684418-84418101.239101.77
极限184137-84137100.90299.732.77101.73100.452.82
284520-84520101.362102.11
378484-7848494.12394.71
484053-84053100.802101.55
583934-83934100.659101.39
683831-83831100.535101.23
坎地沙坦酯片项目信息
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对照品来源中检所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%
115.987520175173750737547675169752180.21
216.077589975927759130.03
单位质量响应值RSD%判断
4707.014723.900.26数据可信
供试品溶液-12412515批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14852-48525.7767.5227.835.787.5227.80
24684-46845.5765.58
34987-49875.9375.94
46933-69338.2548.25
57420-74208.8348.83
69010-901010.72610.73
10min117818-1781821.21225.7418.2621.2225.7518.27
220630-2063024.56024.57
320680-2068024.62024.63
418040-1804021.47721.49
524632-2463229.32529.34
627919-2791933.23833.26
15min134765-3476541.38848.1214.0941.4348.1714.09
240042-4004247.67047.72
340917-4091748.71248.76
433912-3391240.37240.42
543696-4369652.02052.08
649172-4917258.53958.61
20min149797-4979759.28467.7611.1959.4067.9011.20
257873-5787368.89869.03
359326-5932670.62870.76
449129-4912958.48858.61
559681-5968171.05171.20
665695-6569578.21078.38
30min169911-6991183.22989.675.5883.4489.925.60
276880-7688091.52691.77
377357-7735792.09492.34
470154-7015483.51983.73
578042-7804292.90993.18
679573-7957394.73295.03
45min179884-7988495.10298.662.4295.4599.062.45
283592-8359299.51799.91
383765-8376599.723100.13
480929-8092996.34696.70
585004-85004101.198101.62
684078-84078100.095100.55
60min182359-8235998.04999.731.4298.56100.291.44
283985-8398599.985100.55
384414-84414100.495101.06
482609-8260998.34698.86
585561-85561101.861102.45
683702-8370299.648100.27
极限182862-8286298.648100.021.6799.32100.751.68
284148-84148100.179100.91
385067-85067101.273102.01
482652-8265298.39899.08
586188-86188102.607103.37
683173-8317399.01899.81
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