Analytical Technologies for Genotoxic Impurities in Pharmaceutical Compounds

Genotoxic impurities (GTIs) have gained considerable attention from health authorities as well as from the pharmaceutical industry in recent years. Analysis and control of these impurities in pharmaceutical compounds pose a significant challenge, often requiring selective, sensitive, and robust trace-level methods for analysis. This article focuses on the method development strategy and associated technologies for the analysis of GIN. GTIs typically have a wide range of physicochemical properties such as volatility, stability, presence of UV chromophores, ionizable groups, and derivatizable functional groups. Various separation and detection technologies are available and can be used to identify and analyze. Choosing the appropriate analytical technique depends on the GTI physicochemical properties, required sensitivity, and the consideration of the matrix interference.