The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the
International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and
degradation products also helps us to understand the production of impurities and assists in defining
degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a…
