ICH Guideline Q3C (R8) on Impurities: Guideline for Residual Solvents

28 November 2022 – EMA updated step 5 of the ICH guideline Q3C(R8) on residual solvents.

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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