Elemental Impurity Studies

We Perform Elemental Impurity Testing On:

  • Active Pharmaceutical Ingredients (APIs) / Drug Substance
  • Drug Products (Tablets, Capsules, Injectables, Ointments, Lotions, Syrups, Suspensions, Gels, Inhalations, Creams & Emulsion, Transdermal Patches etc.,)
  • Raw materials
  • Intermediates
  •  Excipients

Our Elemental Impurity Testing And
Validation Services Include:

  • Elemental Impurity analysis according to USP General Chapter <232> Elemental Impurities-Limits and <233> Elemental Impurities- Procedures, ICH Q3D, EMA Guideline and/or customer requirements
  • Techniques used are ICP MS and samples
    are processed by both conventional and
    microwave digestion
    system.