Program

Poster Presentations

Day 3, May 17（Thu.）　　Poster

3P-19　　PDF

Identification of Leachables and Extractables using LC/QTOF and GC/MS

(Agilent)
^oChika Nogami, Takeshi Otsuka, Masahiro Okuda, Takeshi Serino, Sadao Nakamura, Hirokazu Sawada

Drug substances and products can be 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. As the multiple and often complementary analytical techniques, LC/MS and GC/MS are used for Extractables & Leachables (E&L) screening. LC/MS and GC/MS technique enables the rapid and efficient identification of E&L.