Elemental impurities pose serious risks to patients. Modern methods provide better analytical tests to detect elemental impurities, which will help protect patients by ensuring approved products have safe levels of these impurities.
Elemental impurities include catalysts and environmental contaminants in drug substances, excipients, or drug products. These impurities may occur naturally, be added intentionally, or be introduced inadvertently (e.g., by interactions with processing equipment and the container closure system). When elemental impurities are known to be present, have been added, or have the potential for introduction, assurance of compliance to the specified levels is required.

Services provided by IAS for Elemental Impurities:
  • Elemental Impurity analysis according to ICH Q3D and USP General Chapter <232> Elemental Impurities-Limits and <232> Elemental Impurities-Procedures and/or customer requirements
  • Analytical Method Development and Validation for Elemental Impurities Analysis
  • Risk Assessment Studies
  • Analysis of Elemental Impurities in Drug Product, Drug Substance, Intermediate, Raw Material
Instruments available at IAS
  • ICP-MS (Make:- Thermo)
  • Microwave Digester (Make:- Anton Paar)