Guidance on nitrosamine impurities in medications.: H164-327/2024E-1-PDF
"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 document 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 document, 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). …"--Background, page 1.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.938524&sl=0
| Department/Agency |
|
|---|---|
| Title | Guidance on nitrosamine impurities in medications. |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Later edition | Guidance on nitrosamine impurities in medications. (August 2025) |
| Earlier edition | Guidance on nitrosamine impurities in medications. (March 2024) |
| Format | Digital text |
| Electronic document | |
| Note(s) |
|
| Publishing information |
|
| Description | 1 online resource (iii, 56 pages) : illustrations (some colour) |
| ISBN | 9780660720524 |
| Catalogue number |
|
| Departmental catalogue number | 240217 |
| Subject terms |
Request alternate formats
To request an alternate format of a publication, complete the Government of Canada Publications email form. Use the form’s “question or comment” field to specify the requested publication.Page details
- Date modified: