Elemental Impurities Regulations – The First 100 Days

Time: 9:50 am - 10:10 am

Date: 14 March


Both the USP and EP implemented changes to the requirements for elemental impurities testing during the winter of 2017/2018. The changes were implemented based on the publication of ICH Q3D regulations in December 2014.

These changes have now been in place for around 100 days so are still in the early stages of being part of the regulations, but this major change has still had a significant impact on the nature of pharmacopeial testing.

The removal of the use of the wet chemistry heavy metals test, to be replaced by specific elemental testing has been the most significant change to the pharmacopeias. Elemental testing that was historically included in monographs has, for the time being, been retained. Compliance with the regulations can seem a burdensome, but through a risk assessment process this burden can potentially be reduced.

In this presentation, a brief background of these regulations will be discussed, along with the impact of the changes on the nature of control of elemental impurities within the pharmacopeias and how this new approach is starting to become incorporated into pharmaceutical control as well as covering some examples of elemental testing that has been retained within the monographs.


  • View full profile for Alan CrossAlan Cross Technical Specialist, Metals Laboratory - Reading Scientific Services Limited

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