High resolution Mass Spectrometry with automated data analysis to support structural elucidation of degradation impurities of small peptides
AAPS 2019 PHARMSCI 360, San Antonio (United States of America)… 03 November, 2019
Structural elucidation of drug substance related impurities in drug products to identify specific degradation pathways is important for the development of formulated drugs, optimization of manufacturing process and in certain cases a requirement for regulatory submissions. The present work utilized an in-silico data processing tool MassChemSite, which has been developed to automate data analysis and to facilitate the structural elucidation of drug degradants by LC-MS/MS. The software was customized to work on structure modifications introduced by common degradation chemistries for small peptides.