Formaldehyde Catalysis of Nitrosamine Formation

New Scientific Knowledge & Development
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A new paper, published just yesterday.

Investigation of the Formaldehyde-Catalyzed N-Nitrosation of Dialkyl Amines: An Automated Experimental and Kinetic Modelling Study using Dibutylamine - Journal of Pharmaceutical Sciences (jpharmsci.org)

The abstract on this is interesting, especially the influence of formaldehyde at neutral and higher pH levels.

I shall be getting the full copy to digest.

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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 (dominant) root cause (as described in the EMA paper) in nitrosamine pre-testing and post-testing, anyone having to do the same will benefit from buying the paper.

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