磷酸奥司他韦混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.861562828156414215645511565711156426615643000.07
29.971559478155976515596220.02
单位质量响应值RSD%判断
158651.12156431.491.00数据可信
长期12月-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
2024111821批116925861698647169561697.9398.811.0897.70%~99.93%
217198591719067171946399.30
317127991712451171262598.91
417030261703680170335398.37
5174333817416641742501100.63
616922711692676169247497.74
2024111921批1174256417453061743935100.72101.961.17100.71%~103.21%
2178787717912511789564103.35
3178068317795711780127102.81
4176616917645661765368101.95
5177551417757801775647102.55
6173810917372841737696100.36
2024112021批1177345817717161772587102.3796.703.6093.05%~100.35%
216341671632303163323594.32
316840091682823168341697.22
416014631604735160309992.58
516471441650407164877695.22
617079611703079170552098.50
磷酸奥司他韦混悬剂项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号101096-202404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)75供试品稀释倍数1系数0.7612
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.861562225156275415632921560686156211615622150.07
29.971562953156443215636920.07
单位质量响应值RSD%判断
158439.66156839.720.72数据可信
中间条件12月-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
2024111821批116988771700567169972298.1096.921.0395.87%~97.96%
216768581677469167716496.80
316778181679697167875896.89
416496571647901164877995.16
516793351679876167960696.94
616898961692630169126397.61
2024111921批1174982517485281749176100.9599.111.6997.36%~100.85%
2173513017350381735084100.14
317334791731562173252099.99
417076561708827170824298.59
516679931667044166751896.24
617102361711069171065298.73
2024112021批116655521667602166657796.1993.781.8891.94%~95.63%
216181871619006161859693.42
316431541643145164315094.83
416004121602003160120892.41
515820951582896158249691.33
616365671639024163779694.52
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