奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.313114103137593137473135563143143133570.36
210.343091253086033088640.12
单位质量响应值RSD%判断
30393.5029870.791.23数据可信
影响因素10天-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024051721批131862931946331904696.4397.252.2694.95%～99.56%
233152032839232995699.73
332871832948832910399.47
432092332128432110497.06
532212832032532122697.09
630986531036631011693.74
2024051721批1336711336642336676101.76100.901.0899.76%～102.05%
2333422332405332914100.63
3337154337274337214101.93
4335546335149335348101.36
5333091333931333511100.81
632741232727932734698.94
l批132691132653932672598.7699.331.6297.64%～101.01%
2334382333857334120100.99
3333389333306333348100.76
432091232039832065596.92
532471032551232511198.27
6331461331948331704100.26
奥司他韦干糖浆项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101096-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)75供试品稀释倍数5系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.313040153083153081743082533083733074260.63
210.343090903084523087710.15
单位质量响应值RSD%判断
29818.2329861.800.11数据可信
影响因素10天-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024051721批1332148330978331563101.1999.381.0098.35%～100.42%
232378332630832504699.20
332471732406332439099.00
432331832338832335398.69
532653032704332678699.73
632262232281732272098.49
2024051721批131846231874631860497.2496.760.6496.12%～97.41%
231502131412131457196.01
331828031873231850697.21
431381931494131438095.95
531832431823831828197.14
631812131770831791497.03
l批132396432355932376298.81100.121.3698.70%～101.54%
232267332268332267898.48
332732732672932702899.81
4334000334481334240102.01
5329936329085329510100.56
6330946331303331124101.06
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