EAG Life Sciences

Extractables and Leachable (E&L) studies challenge our industry due to their late stage occurrence and investigational nature. This white paper defines Extractables and Leachables and outlines an E&L study plan that is both scientifically relevant and compliant within GXP regulatory systems.

The implementation of the proposed chapters USP chapters on elemental impurities, <232> and <233> is best suited to the use of closed vessel digestion and analysis by an ICP analytical technique. This paper addresses the challenges involved, as well as appropriate methods, procedures, and limits associated with this analysis.

Genotoxic Impurities and Potential Genotoxic Impurities (GIs, PGIs) pose analytical method development and validation challenges for pharmaceutical development. This white paper illustrates overcoming specificity and low limits of detection difficulties for quantitative analysis of Genotoxic Impurities and Potential Genotoxic Impurities for methyl, ethyl and isopropyl camphor sulfonate esters in a drug substance.

Extractables and Leachables (E&L) studies challenge our industry due to their late stage occurrence and investigational nature. This white paper defines Extractables and Leachables and outlines an E&L study plan that is both scientifically relevant and compliant within GXP regulatory systems.

The reactive nature of genotoxic impurities and potential genotoxic impurities poses unique analytical method development and validation challenges. This case study illustrates a difficult development and validation for quantitative analysis of genotoxic impurities and potential genotoxic impurities for methyl, ethyl and isopropyl camphor sulfonate esters in a drug substance.