Guidance
Nitrosamines impurities in medicines
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
Documents
Details
The Medicines and Healthcare products Regulatory Agency (MHRA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and has provided guidance for manufacturers to avoid the presence of nitrosamine impurities.
Updates to this page
Published 24 August 2023