ABSTRACT
Introduction In the early stages of new drug development, understanding the impurity pro-les of the drug substance is critical when interpreting the data from toxicology and clinical studies. ere is a body of regulatory requirements with regard to identication and control of impurities. A commonly used framework used in the pharmaceutical industry is Q3A(R2), the International Conference on Harmonization (ICH) guidance for controlling impurities in new drug substance [1]. Although this guidance is intended only for products approaching application for nal market registration, many companies consider similar elements when evaluating impurities in new chemical entities during the clinical phases of development.
