Manufacturing & Analytical Characterization
Caddy Hobbs, PhD (she/her/hers)
Associate Director
Cambrex
Description: Nitrosamine impurities are genotoxic compounds that must be controlled to very low levels in pharmaceutical products. Recent guidance documents recommend limits for total nitrosamines of < 26.5 ng/day or < 0.03 ppm, which presents a formidable challenge to drug product manufacturers and analytical method developers. This presentation will discuss background, approaches for risk assessment, and analytical method development as they pertain to controlling nitrosamine impurities.