氨氯地平沙库巴曲缬沙坦钠片项目信息
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%
114.699070290630905129043990381905330.15
214.719075890761907600.01
单位质量响应值RSD%判断
6162.906169.950.09数据可信
供试品溶液-氨氯地平-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121179926800057996684.0785.571.9983.79%～87.35%
280601807768068884.82
381251813628130685.47
479740796857971283.80
583350833588335487.63
683222834668334487.62
2024030221178835787757880582.8484.501.7482.97%～86.04%
280376804458041084.53
380135801318013384.24
482566825718256886.80
581297812408126885.43
679135791137912483.18
2024030321178390782497832082.3383.724.7879.52%～87.91%
276911768647688880.83
377648775217758481.56
478377787317855482.58
579236792837926083.32
687128872918721091.68
氨氯地平沙库巴曲缬沙坦钠片项目信息
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57323100856对照品来源ZZ对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.521532154153167715339421535169153446415334810.10
222.531554359155472815545440.02
单位质量响应值RSD%判断
68094.1868998.850.94数据可信
供试品溶液-沙库巴曲-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121116977131698877169829550.1050.710.6950.35%～51.07%
217220631721295172167950.79
317186531723111172088250.77
417339671734797173438251.16
517226951721678172218650.80
617172991716061171668050.64
2024030221117056791704686170518250.3050.741.1450.14%～51.35%
217257831723877172483050.88
317523131751792175205251.68
417190151720112171956450.73
517247931723913172435350.87
616931541696601169487850.00
2024030321116109461611952161144947.5449.932.5148.62%～51.25%
216917011691290169149649.90
316921141692023169206849.92
417127701708865171081850.47
517257481731679172871451.00
617200251721595172081050.76
氨氯地平沙库巴曲缬沙坦钠片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
122.521025205102738110270011025966102582010262750.09
222.531034439103269610335680.12
单位质量响应值RSD%判断
45571.7145875.190.47数据可信
供试品溶液-缬沙坦钠-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121111329891131108113204847.3348.030.7947.63%～48.43%
211504581151239115084848.12
311513701151432115140148.14
411588451159862115935448.48
511498941150049114997248.08
611476621149573114861848.03
2024030221111349931134808113490047.4548.031.2647.40%～48.66%
211534431154972115420848.26
311715871170190117088848.96
411477541145640114669747.95
511539781153334115365648.24
611326041130743113167447.32
2024030321110718411073440107264044.8547.212.6345.91%～48.51%
211280621127107112758447.15
311299391128718112932847.22
411421091142320114221447.76
511543281154305115431648.26
611480531149344114869848.03
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