IPEC Federation position on The Role of Excipients in Determining N-Nitrosamine Risks for Drug Products

Category: IPEC Federation
  • 1 Mar 2022

The International Pharmaceutical Excipients Council Federation, (IPEC Federation) announces the availability of a new position paper, “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 (nitrosamine) risk assessments for drug products.

The presence of N-nitrosamines in drug products continues to be a global concern. Excipients are considered as a potential risk factor during the drug product risk assessment. The focus of this position paper is to expand on the potential contribution excipients may or may not have on the formation of nitrosamines in final drug products. The presence of nitrites and vulnerable amines in excipients are also considered.

The position paper is available for download immediately via the website www.ipec-federation.org and on the regional IPEC websites, including IPEC Europe.

For further information contact the IPEC Federation Secretariat at +32 2 213 74 40 or write to info@ipec-federation.org.

Download the press release

Access the IPEC Europe Questionnaire (version 3, 2021)

Read the Position Paper