The WHO Prequalification Team (PQT) is aware, and monitoring closely, announcements by major regulators regarding the presence of nitrosamine impurities in batches of sartan-related products, pioglitazone, and more recently, ranitidine.
For the majority of the active pharmaceutical ingredients (APIs) used in prequalified products, the chance of nitrosamine formation arising from the declared synthetic preparation is low. However, recent EU advice has highlighted the risk of nitrosamine content from contaminated materials, in particular, recovered materials.
Whilst PQT considers the next appropriate actions, manufacturers are advised to study recent advice from the major regulators
For further enquiries please contact Dr Matthias Stahl, Group Lead Medicines Assessment, WHO Prequalification team. Email stahlm@who.int