PerkinElmer
USP 232/233+ICH Q3D Elemental Impurities Capabilities

Brochure

USP <232>/<233> & ICH Q3D Capabilities Brochure

Identification and quantification of elemental impurities

Introduction

The International Conference on Harmonization Guideline for Elemental Impurities Q3D (ICH Q3D) has established maximum permitted daily exposure limits for elemental impurities in pharmaceutical products. In combination with the U.S. Pharmacopeia’s (USP) Chapters <232> and <233> on elemental impurities, they redefined how the pharmaceutical and related supply-chain industries will measure, document, and comply with strict new standards to limit the presence of elemental impurities in drug products.

PerkinElmer provides the tools and processes you need to take control of impurities testing for both drug substances and drug products, providing proven, reliable technology for the identification and quantification of elemental impurities and the accurate measurement of residual solvents in accordance with strict regulatory guidelines.

Download this brochure to learn more.