Nitrosamines Risk Assessment – Deadlines & Updates

Nitrosamines Risk Assessment

Nitrosamines Risk Assessment – Deadlines & Updates


In both 2018 and 2019 the presence of N-nitrosamines was found in sartans with a tetrazole ring but it was also detected in other API/medicinal products (e.g. in some batches of pioglitazone and ranitidine). Since N-nitrosamines are probable human carcinogens, the presence of these compounds in human medicinal products should be mitigated as much as possible.


  • To allow Marketing Authorisation Holders (MAHs) enough time to implement the Article 5(3) opinion, the European medicines regulatory network agreed new deadlines: MAHs should perform a risk evaluation to determine whether chemically synthesized active pharmaceutical ingredients (APIs) are at risk for containing nitrosamines by March 31st, 2021. Products containing biological APIs should undergo this first step in risk evaluation by the 1st of July, 2021.
  • On September the 1st, 2020 the Food and Drug Administration (FDA) announced the availability of a guidance for industry, entitled “Control of N-Nitrosamine Impurities in Human Drugs.” This guidance recommends steps manufacturers of APIs and drug products should take to detect and prevent objectionable levels of nitrosamine impurities in pharmaceutical products. The guidance also describes conditions that may introduce nitrosamine impurities.

The above updates allow pharmaceutical companies from now on to define a common strategy for the Nitrosamines Risk Assessment process.

Asphalion can give you support in the preparation of the Risk Assessment for presence of Nitrosamine content.

We offer a global service that covers risk analysis, analytical phase and includes regulatory support with variation management. The end of the year is around the corner, so do not hesitate to contact us at in order to obtain specialized advisory and support!

Asphalion is here to help you!

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