The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on general chapter 2.4.20. Determination of elemental impurities. Updated in the context of discussions within the Pharmacopoeial Discussion Group (PDG), the text is intended to become the new harmonised standard for elemental impurities testing. While this revised version comes with a completely new structure, it retains the flexible approach of the previous version of chapter 2.4.20 and users can continue to select any suitable analytical procedure provided the requirements for validation given in the chapter are met. This concept for elemental impurities testing, introduced in the European Pharmacopoeia as early as 2012 together with the publication of the former EMA guideline on metal catalysts and metal reagent residues (now replaced by ICH Q3D), has shown its appropriateness over the years.
The harmonisation of this important text will support the further implementation of the principles for the control of elemental impurities laid out in the ICH Q3D Guideline, already widely integrated into the Ph. Eur.
The text has been published for public consultation in Pharmeuropa 31.4 (October issue) and the commenting period ends on 31 December 2019.
More information on Pharmeuropa 31.4 (October issue)