Summary

Implementation of International Council for Harmonisation (ICH) of Technical Requirements of Pharmaceuticals for Human Use Guidance Q3C(R6): Impurities: Guideline for 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.

This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process.

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