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Elemental Impurity Analysis in Pharmaceuticals – The Road To Implementation of ICH Q3D

Format: PDF file | Document type: White / Technical Paper

The International Conference of Harmonisation (ICH) guidance document on elemental impurities, Q3D, reached step 4 in December 2014, meaning the final draft is recommended for adoption. This paper outlines the key timeframes for implementation in the EU and US and considerations for ensuring compliance.