Inherent with the high maximum daily doses encountered in large volume parenteral applications, screening results have to be evaluated at a low concentration level, often close to the lower limits of the analytical methods. The reported list of extractables or leachables is often extensive, where a correct identification for each of the reported compounds is key to allow an accurate and comprehensive toxicological assessment. In this presentation, we will touch on some key aspects of good identification practices in first-pass evaluations and how to increase the identification level of unknown or only partially identified compounds using high-end analytical techniques in second-pass evaluations.

This presentation was recorded on March 24 and is part of a series.