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Elemental Impurity Analysis in Pharmaceuticals and Implementation of ICH Q3D

Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these impurities in drug products and ingredients.

Their guidance document, Q3D, reached step four in December 2014, meaning the final draft is recommended for adoption to regulatory bodies of the European Union, Switzerland, Japan, US and Canada.



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