By Todd Sprouse, M.S. Sr. Manager, Analytical Services Caddy Hobbs, Ph.D. Associate Director, Analytical Services Erik Feldmann, Ph.D. Technical Director, Early Stage Development & Testing
Published in: Pharmaceutical OnLine
Published on: November 3, 2024
N-nitrosamines (referred throughout as “nitrosamines”) are a class of highly potent genotoxins containing a functional group (NO+) bound to an amine (see example in Figure 1), are listed as potential human carcinogens. with a growing number of drugs recalled from 2018 onwards for the presence of nitrosamines such as N-nitrosodimethylamine (NDMA) in certain receptor antagonist/sartan drugs, ranitidine, and metformin drug products, the Food and Drug Administration (FDA) has continued to release updated Guidance for Industry regarding acceptable nitrosamine levels.
