N-Nitrosamine drug substance related impurities (NDSRIs) – A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da

Joel P. Bercu, Olivier Dirat, Krista L. Dobo, Robert A. Jolly, Michelle Kenyon, James Harvey, Raphael Nudelman, G. Smith, Alejandra Trejo‐Martin, Mike W Urquhart