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: https://www.mdpi.com/article/10.3390/pharmaceutics15082015/s1