Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation

Dr. Berardi published a new paper comparing the best-case scenario with the worst-case scenario to evaluate the impact of excipient change on nitrosamine formation. We may avoid the generation of NDSRIs without adding antioxidants in DP manufacturing.

And supplementary materials help us evaluate the impact of excipient change through a spreadsheet. It’s excellent!!

Supplementary Materials:


I want to call all your attention to review the Excel calculation tool that Dr. Berardi et al. produced with the publication on the modeling of impact on nitrosamine formation.

Excel calculation tool: