IPEC: Position on the role of excipients in determining N-Nitrosamine risks for drug products 🇬🇧

The International Pharmaceutical Excipients Council Federation, (IPEC Federation) published a new position paper on “The Role of Excipients in Determining N-Nitrosamine Risks for Drug Products”. This paper describes IPEC Federation’s position on the role of excipients when conducting N-nitrosamine risk assessments for drug products.

It is reminded that European authorities request that testing of N-nitrosamines in raw materials (e.g. excipients) is to be considered if these are potential sources of nitrosamine impurities (see our News of 17/02/2022). Excipients are considered as a potential risk factor during the drug product risk assessment.

The focus of this new position paper is to expand on the potential contribution excipients may or may not have on the formation of nitrosamines in final drug products. This document also considers …