00000000nam 2200000zi 4500
0019.948416
003CaOODSP
00520250819081429
006m     o  d f      
007cr mn|||||||||
008250226e20250801onca    ob   f000 0 eng d
020 |a9780660759883
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH164-327/2025E-PDF
24500|aGuidance on nitrosamine impurities in medications.
24617|aNitrosamine impurities in medications : |bguidance
250 |a[August 2025 edition].
264 1|aOttawa, ON : |bHealth Canada = Santé Canada, |c2025-08-01.
264 4|c©2025
300 |a1 online resource (ii, 48 pages) : |billustrations
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aIssued also in French under title: Lignes directrices sur les impuretés de nitrosamine dans les médicaments.
500 |a"Evaluating and managing the risks of N-nitrosamine impurities in human pharmaceutical, biological and radiopharmaceutical products."
500 |a"Date adopted: 2025-08-01."
500 |a"Effective date: 2025-08-01."
504 |aIncludes bibliographical references.
520 |a"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.
650 0|aNitrosoamines|xRisk assessment|zCanada.
650 0|aDrugs|xRisk assessment|zCanada.
650 0|aBiologicals|xRisk assessment|zCanada.
650 0|aRadiopharmaceuticals|xRisk assessment|zCanada.
650 0|aPharmaceutical policy|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tLignes directrices sur les impuretés de nitrosamine dans les médicaments.|w(CaOODSP)9.948417
795 |tGuidance on nitrosamine impurities in medications.|b(May 2024)|w(CaOODSP)9.938524
85640|qPDF|s1.37 MB|uhttps://publications.gc.ca/collections/collection_2025/sc-hc/H164-327-2025-eng.pdf
8564 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities/medications-guidance.html
986 |a240894