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Home » FDA Follows ICH Guidelines in Q3D(R2) Elemental Impurities Guidance
FDA Follows ICH Guidelines in Q3D(R2) Elemental Impurities Guidance
In publishing Q3D(R2) – Guideline for Elemental Impurities, the FDA has taken another step towards endorsing International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, this time focusing on catalysts and environmental contaminants that may be present in drug substances, excipients or drug products.