A New Framework For Identifying Nitrosamine Risks And Efficiently Derisking Products

By Jason Brown, Senior Manager, Analytical Sciences, R&D, Adare Pharma Solutions

Following the release of the FDA’s guidance on Nitrosamine Drug Substance-Related Impurities (NDSRIs), pharmaceutical companies need to adopt a systematic approach for identifying susceptible Active Pharmaceutical Ingredients (APIs). Despite extensive research and industry efforts, a clear definition of APIs at risk for NDSRI formation remains elusive. This paper presents a novel framework developed by Adare's nitrosamine experts to streamline the identification of such APIs.

The framework leverages the FDA's NDSRI guidance while acknowledging the limitations in compound-specific carcinogenicity data. It offers a structured approach for predicting the carcinogenic potential of NDSRIs based on structural features, thereby facilitating informed risk assessments for APIs.

Examine how this approach holds significant promise for the pharmaceutical industry, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance with upcoming regulatory deadlines.