比拉斯汀口崩片项目信息
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D1BSF0200923对照品来源自制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500
标示量(mg)20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%
110.953734283736083732493738113733033734800.07
210.933741223738393739800.06
单位质量响应值RSD%判断
34107.7634215.920.23数据可信
影响因素5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
2024121821批1387386388058387722101.74100.951.7299.13%～102.77%
2382788382971382880100.47
337741037716637728899.00
4395968396190396079103.93
538011538013938012799.74
6384561384020384290100.84
2024121821批1386026385722385874101.25100.150.8299.29%～101.01%
237681237620237650798.79
3381892382146382019100.24
4383025382870382948100.49
5382355382328382342100.33
638010638037838024299.78
l批1385045385592385318101.11100.081.2298.81%～101.36%
2380785381746381266100.04
338065438042838054199.85
437724737782937753899.07
537549137604937577098.60
6388145388049388097101.84
比拉斯汀口崩片项目信息
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D1BSF0200923对照品来源自制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500
标示量(mg)20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%
110.953732693737643740893728993735853735210.13
210.933730103735063732580.10
单位质量响应值RSD%判断
34111.5134149.860.08数据可信
影响因素5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
2024121821批137965337891837928699.61100.020.2899.73%～100.31%
238085638020938053299.94
3381473381880381676100.24
438019137992238005699.82
5382153381166381660100.24
6381874381861381868100.29
2024121821批137068437014637041597.2898.381.6796.66%～100.10%
236627636617036622396.18
337220537296737258697.86
438077638031038054399.94
5383274382337382806100.54
637513437489037501298.49
l批1387152386954387053101.6599.821.5898.18%～101.47%
237500237488037494198.47
337816737766037791499.25
437869537873837871699.47
5387321388443387882101.87
637367937442137405098.24
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