Nitrosamines Exchange

IPEC Excipient new questionnaire, October 2025

Guidance, Documents, Resources

Excipients

Naiffer_Host October 23, 2025, 12:56pm 2

Also reference here… thanks

Updated: IPEC Questionnaire for Excipient Nitrosamines Risk Evaluation Guidance, Documents, Resources

The International Pharmaceutical Excipients Council Federation, (IPEC Federation) announces the availability of the updated “Questionnaire for Excipient Nitrosamines Risk Evaluation ” (version 2, 2025). 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 produ…

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