This paper was published in Reviews in Separation Sciences Rev. Sep. Sci. 3(1), 3 -20 (2021)

Using high-performance and highly sensitive screening meth­ods to detect unexpected leachables in finished drug products, such as biologics, large volume parenterals, and polymer-based finished products, is very important. This analysis needs to be done with advanced analytical instrumentation that can detect targets at ppb or sub-ppb levels, which can present challenges for some extractable and leachable studies.

Download this complimentary scientific paper to learn about the importance of a GC-MS based screening method(s) for testing stability samples for leachable impurities.