Please keep in mind that conducting a thorough risk assessment is absolutely vital for navigating the complexities of nitrosamines. You cannot simply take your supplier’s word for it when they claim their products are “nitrosamines-free” without providing proper documentation or confirmatory data. Just recently, a Nitrosamines team confidently presented me with a folder filled with declaration letters to prove that their product, Metformin, posed no risk.
I recognize that not every organization has dedicated teams of medicinal or organic chemists readily available to review API synthetic routes or DMFs. However, it’s crucial to revisit and enhance your understanding of organic chemistry. Remember, you’re not alone in this endeavor. Our community offers a wealth of resources and expertise that can provide valuable guidance, but it’s important to take ownership of your learning and not expect others to do the work for you.
Here are great articles from the early days of Nitrosamines that can help you on that journey…
An Organic Chemist’s Guide to N-Nitrosamines: Their Structure, Reactivity, and Role as Contaminants
Access: https://doi.org/10.1021/acs.joc.0c02774
Nitrosamine Reactivity: A Survey of Reactions and Purge Processes
Access: https://doi.org/10.1021/acs.oprd.1c00162
Pathways for N-Nitroso Compound Formation: Secondary Amines and Beyond
Access: https://doi.org/10.1021/acs.oprd.0c00323
Approaches and Considerations for the Investigation and Synthesis of N-Nitrosamine Drug Substance-Related Impurities (NDSRIs)
Access: https://doi.org/10.1021/acs.oprd.3c00084