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Does your drug product require nitrosamine testing?


Dec 2, 2020
By M.Turner

In a variety of regulatory regions all medicines should be tested for the presence of nitrosamine (N-Nitrosodimethylamine).

The requirement for the Marketing Authority Holders is to carry out a risk analysis on their products if they contain chemically synthesized APIs and to follow this with investigatory testing. If nitrosamines are found, there is a requirement to notify Competent Authorities (or their equivalent) and then to make the required changes to production through a variation application.

The deadlines for the EMA are for the outcome of the risk evaluation to be reported by the 31st of March 2021 for chemical medicines and the 1st of July 2021 for biological medicines. Then the confirmatory testing must be reported by the 26th of September 2022 for chemical medicines and the 1st of July 2023 for biological medicines. The same deadlines (as for testing) apply to submission of the variation applications.

In the USA the risk assessment deadline is the end of February 2021 and the testing deadline September 2023.

Medical Engineering technologies can work with your team to develop methods to identify and quantify these and other impurities in your API. GC and LC techniques can be applied.


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