Complying with USP <232> and ICH Q3D guidelines to ensure the safety of drugs and drug products.

Elemental impurities in pharmaceuticals may originate from several sources in the manufacturing process; they may arise from interactions with processing equipment, container closure systems or may be present in components of the drug product.

Determination of elemental impurities in drugs, medicinal products, and raw materials, as well as elemental contaminants in dietary supplements, plays a significant role in pharmaceutical development and manufacturing. Demonstrating compliance with the United States Pharmacopeia (USP) and the International Conference on Harmonization (ICH) is vital to ensure safety and quality of drug substances or finished drug products.

Exova’s elemental impurity testing and validation services include:

  • Elemental Impurity analysis according to USP General Chapter <232> Elemental Impurities-Limits and <233> Elemental Impurities-Procedures
  • Elemental Impurity analysis according to ICH Q3D Guideline for Elemental Impurities

Our laboratory is Good Manufacturing Practice (cGMP) compliant and ISO/IEC 17025 accredited. We test for elemental impurities by ICPMS and ICPOES in compliance with USP, EP, and ICH to give you reliable, independent data for a broad range of finished products and raw materials in the pharmaceutical, medical device, consumer product and dietary supplement industries.