Conference Recording: Analytical approaches to cover potentially harmful impurities in drug formulations

Despite guidance regarding the assessment of genotoxic impurities in ICH M7, there are still many challenges when it comes to analytical screening and characterization of such compounds. Frequently, the interference of drug matrix components makes impurity analysis quite difficult. Moreover, in case of the presence of substances of the cohort of concern the analytical limits are often extremely low and therefore challenging with current methods or instruments.


During the 3rd Annual Genotoxic Impurities Summit, our expert presented "Analytical approaches to cover potentially harmful impurities in drug formulations" covering the following topics: 

• Sources and kind of potential impurities
• General screening strategies to cover the risks
• Case studies about characterization and quantification of impurities
• Importance of structure elucidation
• Special considerations for substances of cohort of concern not suitable for TTC approach

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