Analytical toolkit, nitrite monitoring, regulatory updates, and mitigation strategies in one visual.
A few key points:
LC-MS/MS and GC-MS/MS remain our workhorses, but HRMS is becoming essential for unknown NDSRI identification
Nitrite monitoring in excipients is no longer optional. It’s where many contamination stories begin
The CPCA framework and FDA Revision 2 have changed how we approach risk assessment
¹⁵N-NMR Nitrosation Assay (NAP) is a 2025 innovation worth watching
This roadmap is intended to provide perspective and support structured thinking.
Hope it’s useful for the community.
