洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.811163821116417711635771162799116297911634710.05
213.761162744116426711635060.10
单位质量响应值RSD%判断
84248.4484557.120.26数据可信
长期3月-供试品溶液-水
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025020621112775591276712127713699.3099.532.7396.68%~102.38%
2129695512999981298476100.96
3128915712884651288811100.21
412120911211632121186294.23
5130688013061771306528101.59
6129865212964781297565100.89
20250207211132376413238141323789102.93101.961.20100.68%~103.23%
2129521212951961295204100.71
3131532613140421314684102.22
4130444013054601304950101.46
5133378813337101333749103.70
6129771512930461295380100.72
20250208211132094813220191321484102.75102.711.01101.63%~103.79%
2133488913353231335106103.81
3133248813322291332358103.59
4131932913191451319237102.57
5132089413192221320058102.64
6129668912983791297534100.89
洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.811165486116645611643131163870116459311649440.09
213.761159206116114511601760.12
单位质量响应值RSD%判断
84355.1084315.120.04数据可信
加速3月-供试品溶液-水
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20250206211130906913104671309768101.92100.881.3999.41%~102.34%
2130773313096781308706101.84
3130216813003961301282101.26
4130695413051931306074101.63
5128886212897671289314100.33
612624111263947126317998.29
2025020721112836781284310128399499.91100.051.9498.02%~102.09%
2132922613285601328893103.41
312657481265741126574498.49
4129491412987591296836100.91
512588621260804125983398.03
612791241279662127939399.56
2025020821112849421284949128494699.99101.501.8599.53%~103.47%
2131403413140341314034102.25
312729711272768127287099.05
4129672412934021295063100.77
5132297813224571322718102.93
6133563613372121336424103.99
洛索洛芬钠细粒剂项目信息
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100638-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.811163071116349111637991162654116235211630730.06
213.761160242115870011594710.10
单位质量响应值RSD%判断
84219.6284263.880.04数据可信
中间条件3月-供试品溶液-水
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025020621112791201278143127863299.61100.250.7899.43%~101.06%
2130473213065901305661101.71
312817231280313128101899.79
412801831280812128049899.75
5128674812857351286242100.20
6128959712885861289092100.42
2025020721112749381275699127531899.35100.301.2998.94%~101.65%
2130747313064421306958101.81
312803881281140128076499.77
4130467613058451305260101.68
5129134312905331290938100.57
612655941265711126565298.60
20250208211130137112991901300280101.29103.001.32101.58%~104.42%
2130887513073131308094101.90
3133130113314551331378103.72
4134783713484961348166105.02
5132888513277841328334103.48
6131707513164491316762102.58
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