USP Elemental Impurities Implementation Set for January 2018

Published on: 

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.


The US Pharmacopeial Convention (USP) has announced plans to establish Jan. 1, 2018 as the new date of applicability of General Chapters <232> Elemental Impurities-Limits and <2232> Elemental Contaminants in Dietary Supplements. The date change was made to align more closely with implementation of the International Conference on Harmonization (ICH) Q3D, Guideline for Elemental Impurities.

In December 2014, ICH released the Step 4 version of ICH Q3D, Guidelines for Elemental Impurities, to regional standards organizations for implementation. The document stated that application of ICH Q3D to existing products was not expected prior to 36 months after publication.


USP reports that that users can continue to use the current General Chapter <231> Heavy Metals approach or implement the new <232>/<2232> approaches until Jan. 1, 2018, at which time General Chapters <232> and <2232> will be made applicable to drug product and dietary supplement monographs as described in General Notices 5.60.30. 

Source: US Pharmacopeial Convention