The ICH Q3C(R8) Guideline Reaches Step 4 of the ICH Process

On 23 April 2021 the ICH announced the status of the maintenance process for the ICHQ3C(R8) guideline.

The ICH Q3C(R8) Guideline on Impurities: Guideline for Residual Solvents, revised to include the Permitted Daily Exposure (PDE) levels for 2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether and Tertiary Butyl Alcohol, reached Step 4 of the ICH Process in April 2021. Additionally, a Step 4 Introductory Training Presentation has also been developed by the Maintenance Expert Working Group.

The objective of this guideline is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.

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