A Comparative Study of N-Nitrosomorpholine and N-Nitroso Reboxetine Potency

Establishing regulatory limits for NDSRIs is challenging due to the limited genotoxicity and carcinogenicity data available for many of these impurities, often leading to conservative approaches. In this study, we evaluated the genotoxic potential of two structurally related nitrosamines: N-Nitrosomorpholine (NMOR) and N-Nitroso Reboxetine. While both compounds tested positive in a series of in vitro and in vivo assays, we found that the mutagenic potential of N-Nitroso Reboxetine was significantly lower than that of NMOR.