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Genotoxic Impurities In Development

Have you considered the impact of impurities in your pharmaceutical development? These impurities, including mutagens, carcinogens, and teratogens, may arise from synthetic sources and drug product degradation. Assessing and controlling these impurities is crucial to mitigate carcinogenic risks.


Following FDA Guidance’s [M7 (R1) and M7(R2)], it's essential to adhere to a maximum daily intake of 1.5 µg per person, the level of toxicological concern indicating an acceptable cancer risk. Characterizing your API and drug product, and identifying genotoxic impurities using validated methods, is imperative.


For highly potent impurities, FDA engagement may be necessary to establish stringent exposure limits, especially for clinical trials. Contact us for further insights on these critical considerations!

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