Health Canada: Guideline for Residual SolventsPublished on May 2, 2018
Author: Bhavesh Patel, C. Chem.
Health Canada recently announced the implementation of the ICH Guidance “Q3C(R6) Impurities: Guideline for Residual Solvents” (the “Guidance”)
The Guidance has been developed by the ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly endorsed the final draft and recommended that ICH membership implement the document.
The principal effect of the Guidance is to revise the permitted daily exposure (PDE) for methyl isobutyl ketone (MIBK) and to add Triethylamine (TEA) as a new solvent. Based on new data, MIBK was moved from Class 3 (solvents with low toxic potential) to Class 2 (solvents to be limited). The new solvent Triethylamine was included in Class 3 (solvents with low toxic potential)
Please see below links for more details on the Guidance.
Thank you for reading Regulated Affairs, the CAPRA Blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media.
Artificial Intelligence – Revolutionizing the Healthcare Industry
What is Artificial Intelligence? Artificial intelligence (AI) is a broad term for a category of algorithms and models that perform tasks and exhibit behaviors such as...
Technology Continues to Transform Healthcare and the Regulatory World
Introduction: Digital health solutions are advancing rapidly in the field of diagnostics, emergency response, hospital management. As the goal of individuals shifts more...
Rare Diseases and Orphan Drugs Regulatory Framework in Canada: Recent Initiatives by Government of Canada
What are Rare Diseases and How do They Affect Canadians? According to Health Canada, rare diseases are life-threatening, debilitating, or serious and chronic conditions that...