药包材中萃取物与浸出物检测方案(气相色谱仪)

智能文字提取功能测试中

Agilent Technologies EXTRACTABLES AND LEACHABLES：A COMPLEX ANALYSIS 摘要： Extractables analysiss involves exposing packaging materials to strong conditions (elevatedtemperatures to simulate a worst-case scenario or appropriate solvents to mimic pharmaceuticalproperties) to determine potential compound migration. In leachables analysis， a pharmaceuticalproduct is analyzed at normal conditions to observe actual compound migration. Compoundmigration involves correlating extractables to leachables Extractables analysis involves exposing packaging materials to strong conditions (elevated temperatures to simulate a worst‑case scenario or appropriate solvents to mimic pharmaceutical properties) to determine potential compound migration. In leachables analysis, a pharmaceutical product is analyzed at normal conditions to observe actual compound migration. Compound migration involves correlating extractables to leachables