As this article in PharmaVoice points out, pharmaceutical development and manufacturing is a complicated world in which more than a few mysteries remain. Nitrosamine contamination in drugs is one of those mysteries, which industry and regulatory agencies are working hard to solve.  As we know, simple does not always mean easy, and sometimes the best solution (avoiding the presence of these chemical compounds) is not readily available.

Nitrosamines, which commonly occur in foods, come about from a relatively simple chemical reaction that could occur at different points during the manufacturing of a drug. There are multiple ways nitrosamines are introduced, but a primary one is in the chemical synthesis of several compounds. Specifically, a nitrating step in the process may produce nitrosamines or a solvent from another process gets reused and carries nitrosamines with it. There is a clear relation to the presence of nitrosamines and the synthetic manufacturing process1.  

Read the entire article here.

Check out the EMA’s response to nitrosamine contamination mitigation strategies. Read FDA industry guidance on the issue here.

Disclaimers

  • The material in these reviews is from various public open access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred

References

  1. Gibney, M. (2022, April 19). A pharma mystery: Cancer-causing impurities drive joint search for answers. PharmaVoice. https://www.pharmavoice.com/news/pharmaceutical-impurities-nitrosamines/622244/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202022-04-19%20PharmaVoice%20%5Bissue:41150%5D&utm_term=PharmaVoice