2P-02 PDF
LC-QTOFを用いた医薬品包装材からの抽出物/浸出物の同定
Drug substances and products may become contaminated by chemical compounds from primary and secondary packaging materials. Compounds which can be extracted directly from the container closure systems are called “extractables” while compounds, which are found within the formulation are called “leachables” which are often a subset of extractables. Multiple and often complementary analytical techniques such as LC/MS, GC/MS, and ICP/MS are required for Extractables & Leachables (E&Ls) screening. Here we present that LC/MS technique enables the rapid and accurate identification of extractables and leachables.