I would appreciate your views on whether Chromium Nitride (CrN)-coated tablet punches could have any direct or indirect role in the formation or increase of nitrosamine impurities during tablet compression.
Although CrN is generally considered an inert PVD coating, I am interested in understanding whether there is any known scientific evidence, mechanistic rationale, published literature, or regulatory experience suggesting that CrN-coated tooling could influence nitrosamine levels.
Specifically, I would like to know if catalytic surface effects, coating degradation, metal-mediated reactions, or interactions with formulation components under compression conditions have ever been identified as potential contributors to nitrosamine formation.
Any references, case studies, or practical experience?