This guidance represents Health Canada’s current thinking and recommendations on issues related to N-nitrosamine impurities (nitrosamine impurities or nitrosamines). This guidance may be subject to change as new information becomes available and if further guidance is needed for applicants and market authorization holders (MAHs).
A questions-and-answers (Q&A) document on nitrosamines was issued to MAHs on November 26, 2019. This document has undergone a number of revisions and has been further updated as a guidance and to provide additional details to active pharmaceutical ingredient (API) manufacturers, drug product manufacturers, MAHs and importers of APIs and drug products.
In this guidance, changes from the previous version are identified with the descriptors « new » or « updated » (as applicable). Information on a similar theme is grouped together under general headings (for example, General, Safety and Quality)…
