Health Canada has implemented ICH Guidance Q3C(R8): Impurities: Guideline for Residual Solvents.
Q3C(R8) was developed by the appropriate ICH Expert Working Group. It has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by the membership of ICH. In implementing this ICH guidance, Health Canada endorses the principles and practices described therein.
About the Q3C ICH Guideline
- The ICH Q3C core Guideline reached Step 4 in 1997. At Step 4 of the Process, the final draft is recommended for adoption to the regulatory bodies
- It was originally developed based on a Concept Paper (10 March 1994).
- A maintenance agreement was instituted in 1999 and a Maintenance Expert Working Group (EWG) was formed.
- The agreement provided for the re-visitation of solvent Permitted Daily Exposure (PDE). It also allowed for minor changes to the guideline that included the existing PDEs.
- It was also agreed that new solvents and PDEs could be added based upon adequate toxicity data.
- ICH Q3C provides Permissible Daily Exposures (PDEs) for residual solvents
- PDEs are defined as pharmaceutically acceptable intakes of residual solvents
- Residual solvents are classified based on the evaluation of their possible risk to human health
- Class 1 solvents: Solvents to be avoided
- Class 2 solvents: Solvents to be limited
- Class 3 solvents: Solvents with low toxic potential
- The current revision (R8) provides PDEs for three new residual solvents:
- 2-Methyltetrahydrofuran
- Cyclopentyl Methyl Ether
- Tertiary Butyl Alcohol