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

Published 22 January 2016 | By Butterworth Laboratories Ltd

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 4 in December 2014, meaning the final draft is recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada.

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