Technology Digest: Nitrosamine Impurities – From Raw Materials to Final Drug Product

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What are nitrosamines?

Nitrosamines are a class of mutagenic impurities which contain the nitroso functional group and are formed when a secondary or tertiary amine reacts with a nitrosating agent [1]. Two common nitrosamines include N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), which have been classified as potential human carcinogens by the International Agency for Research on Cancer [1,2]. A carcinogenic response is induced when the N-nitrosamines are activated by microsomal liver enzymes and react with DNA. Low levels of these compounds can be found in food and drinks, such as roasted meats, cheese, and beer, as well as tobacco and pesticides. However, over the past few years, nitrosamines have received a great deal of global attention after being found in medicinal products [1,3].

Download the eBook to continue reading and to learn more about the nitrosamine crisis and the bioanalytical tools used to measure impurities.

This eBook includes:

  • OPINION: Nitrosamine impurities – from raw materials to final drug product
  • APPLICATION NOTE: Reliable HPLC/UV quantification of nitrosamine impurities in valsartan and ranitidine drug substances
  • INFOGRAPHIC: Nitrosamine analysis: techniques and instrumentation
  • WHITE PAPER: The current concerns about genotoxic impurities found in commonly used prescription and over the counter pharmaceutical drugs
  • INTERVIEW: Analysis of nitrosamine impurities: an interview with Javier Jimenez-Villarin
  • APPLICATION NOTE: High sensitivity quantitation of nitrosamine genotoxic impurities

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References

  1. Sedlo I, Kolonic T, Tomic S. Presence of nitrosamine impurities in medicinal products. Hig. Rada. Toksikol. 72(1), 1−5 (2021).
  2. Bloomberg. Carcinogens have infiltrated the generic drug supply in the U.S. (2019): www.bloomberg.com/news/features/2019-09-12/how-carcinogen-tainted-generic-drug-valsartan-got-past-the-fda
  3. Teasdale A. The lurking contaminant. Org. Process Res. Dev. 24(1), 12−16 (2020).

This feature has been brought to you in association with Waters Corporation. The opinions expressed in this feature are those of the author and do not necessarily reflect the views of Bioanalysis Zone or Future Science Group.

 

 

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