Nitrosamine Impurities in Medications: Overview

This document provides information on nitrosamine impurities in medications, including updates on guidance, recalls, test methods, and test results. The Active Pharmaceutical Ingredient (API) contains several medications containing the active ingredient Valsartan, which contain the Nitrosamine impurity, N-Nitroso Dimethylamine (NDMA). Health Canada's Acceptable Intake (AI) limits list has been updated, including nine additional nitrosamine impurities with their corresponding AI limits derived from the Carcinogenic Potency Categorization Approach (CPCA). The list of established AI limits in Appendix 1 has been expanded to include thirteen new nitrosamines with their corresponding CPCA-derived AI limits.

An updated version of the list of established acceptable intake limits has been posted online to include eight additional Nitrosamines and their corresponding AI limits. All Market Authorization Holders (MAHs) have received an informational update regarding Nitrosamine impurities, providing specific details on confirmed Nitrosamine impurities found in related drug products.

Health Canada has also added AI limits for several Nitrosamines that are considered acceptable. Updates to general and quality-related topics include notifying Health Canada of Nitrosamine impurities, risk assessments for Nitrosamine impurities in drug submissions, the threshold for routine testing specifications, testing approaches for multiple strengths of a dosage form, and expectations for un-synthesizable or unpurifiable Nitrosamine impurities. The document explains detailed information about Nitrosamine impurities, including news, background information, information about Health Canada's actions on Nitrosamine impurities, webinars, and Q&A documents.

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities.html##~https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities/established-acceptable-intake-limits.html

Region: Canada