Implementing Elemental Impurities Testing ICH Q3D, USP <232> and <233> Requirements

Elemental Impurities Testing Implementation Presentation by: Wayland Rushing, Ph.D, EAG Laboratories’ Director of Scientific Affairs

The deadline for Phase II implementation of ICH Q3D, USP <232> and <233> is January 1, 2018. In this presentation we review the history of implementing elemental impurities testing, along with the new testing requirements including:

New USP Chapters

  • <232> Elemental Impurities – Limits
  • <233> Elemental Impurities – Procedures
  • <2232> Elemental Contaminants in Dietary Supplements
  • Effective on January 1st, 2018

ICH Guidance

  • Q3D
  • Effective for new NDA/ANDA: June 1st, 2016

FDA Guidance

  • Elemental Impurities in Drug Products

A risk assessment approach is presented, to determine the potential sources of elemental impurities in drug products and drug product components. The challenge of gathering information from manufacturers is discussed, as well as container/closure elemental impurities. Typical elemental impurities programs are described, along with case studies.

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