The International Pharmaceutical Excipients Council Federation, (IPEC Federation) announces the availability of the updated “Questionnaire for Excipient Nitrosamines Risk Evaluation” (version 2, 2025).
This tool assists excipient manufacturers in collecting data in a standardised format to support drug product manufacturers in assessing the risk of nitrosamine impurities.
First issued in 2023, the IPEC Questionnaire has been updated to reflect recent scientific developments, revised authority guidelines, and growing expectations from MAHs.
The updates cover:
- Increased understanding of the formation of nitrosamines;
- Recognition of nitrites in excipients as a potential risk factor for nitrosamine formation (FDA, EMA);
- Increased requests from excipient users for nitrosamine-related excipient information, following recent drug product recalls.
IPEC Federation recommends using the updated version of the IPEC Federation Questionnaire for all new evaluations.
The Questionnaire is available for download immediately via the website www.ipec-federation.org and the websites of regional IPECs (IPEC-Americas, IPEC China, IPEC Europe, IPEC Japan and IPEC India).
A live webinar will be held on Wednesday 12 November (15:00-16:00 CET / 9:00-10:00 ET), to introduce the new version of the Questionnaire, guide participants through the key updates, and share insights for implementing the revised questionnaire. The webinar is free for members of the regional IPECs (IPEC-Americas, IPEC China, IPEC Europe, IPEC Japan and IPEC India). For more information and to register, click here.
For further information contact the IPEC Federation Secretariat at:
+32 2 213 74 40 / info@ipec-federation.org