IPEC: Updated Questionnaire for Excipient Nitrosamine Risk Evaluation
The International Pharmaceutical Excipients Council Federation (IPEC Federation) has released version 2 (2025) of its standardised questionnaire to support nitrosamine risk assessments for excipients.
The update reflects recent scientific advances, revised regulatory guidance and increased information requests following drug product recalls. Key enhancements address the contribution of nitrites in excipients and an improved understanding of nitrosamine formation pathways.
Source:
IPEC Federation: News
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