Nitrosamine impurities were first detected in sartan blood pressure medications in 2018. Since then, there have been further instances of nitrosamine contamination in a range of pharmaceutical products. Due to their high toxicity and ability to be unexpectedly generated, identification of these impurities in APIs is of paramount importance.
In response to this, regulatory bodies around the world have set out detailed guidance recommending steps that API and drug product manufacturers should take to detect and prevent unacceptable levels of nitrosamine impurities in products. An internationally recognised acceptable daily intake limit for common nitrosamines has also been set.
All commercially available pharmaceutical products should be risk assessed for nitrosamine contamination, with the submission of any necessary analytical work. The EMA has highlighted six key common nitrosamines to consider, though more unusual nitrosamines may be emphasised in the risk assessment.