Updated: IPEC Questionnaire for Excipient Nitrosamines Risk Evaluation

Guidance, Documents, Resources
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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 product recalls.

https://www.ipec-europe.org/uploads/publications/2025-if-q-nitrosamines-risk-evaluation-v2-final-1761140589.docx

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). Register here.

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New Questions:

5) Are there any hydroxylamines, hydrazines, hydrazides or hydrazones present in the manufacturing process?

If yes, please provide any relevant information about the chemical name / structure:

6) Vulnerable amines: Are there any secondary and/or tertiary amines present as:

-Final excipient?
-Known impurity of the final excipient?

7) Is there any amide, primary amine or quaternary ammonium salt present as:

-Final excipient?
-Known impurity of the final excipient?

In addition to the above, the information contained in the Annex is more comprehensive.

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thank you so much Yosuke for the shared update!

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