Technical / White Paper

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

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

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

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.

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