NDMA production in the presence of formaldehyde: Competition between acid-catalyzed and formaldehyde-catalyzed reactions

[ccdw]

@MarkS

I’ll have to try and remember where I got this from…

Image is copied from Cioc 2023, Scheme 3

Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies

Formaldehyde Catalysis of Nitrosamine Formation

Interesting paper. The abstract is aligned with some of the principles on this summarized by EMA in an open access paper (equally citing the original Casado work): Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies | Organic Process Research & Development (acs.org) Historically we had to assess when and if formaldehyde (ppm level LOD/LOQ) testing on medicines was critical to exclude this possible (domi…