The revised ICH guideline on elemental impurities in pharmaceuticals, Q3D(R1), has now been finalised and is recommended for adoption (“step 4”). This particular revision includes an updated monograph on cadmium, with a harmonised permissible daily exposure (PDE) value by the inhalation route.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (2019). ICH Harmonised Guideline. Guideline for elemental impurities Q3D(R1). Final version. Adopted on 22 March 2019. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D-R1EWG_Document_Step4_Guideline_2019_0322.pdf

 

The above items were taken from the May 2019 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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