IPEC issues Questionnaire for Excipient Nitrosamines Risk Evaluation

IPEC Federation announced the availability of the “Questionnaire for Excipient Nitrosamines Risk Evaluation” (version 1, 2023).

Excipients can contribute to the formation of nitrosamines in drug products through precursor substances present in the excipient (e.g., nitrites, amines, or other nitrogen containing compounds). The Questionnaire covers aspects like use of any nitrosating agents in the manufacturing process of excipients, use of any secondary or tertiary amines, amides or sodium salts, use of any nitrogen containing recovered solvents, use of chloramine in cleaning process. This questionnaire gives a standard format to provide information about excipients to assist the Marketing Authorisation Holders (MAH) in their evaluation of the risk of the presence of nitrosamine impurities in the final drug product.

IPEC Questionnaire for Excipient Nitrosamines Risk Evaluation