Health Canada: Guideline for Residual Solvents

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.

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 References:

1.       http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3C/ICH_Q3CR6_Step4_09Jan2017.pdf

2.       http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3C/Q3C__R6___Step_4.pdf