Elemental Impurity Studies

Elemental Impurity Studies

  • Elemental impurities in pharmaceuticals might initiate on or next numerous foundations in the industrial progression. Impurities into drug product resulting from elements intentionally added (e.g., catalysts), theoretically existing in the drug substance/ water/ excipients, introduced from manufacturing apparatus, leached from container closure systems
  • Elemental impurities are determined in active pharmaceutical ingredients, medicinal products, and raw materials, plays a important role in pharmaceutical development and manufacturing. Demonstrating compliance with the International Conference on Harmonization (ICH) and United States Pharmacopeia (USP) is vibrant to ensure safety and quality of drug substances or finished drug products.

Our elemental impurity testing and validation services include:

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

Elemental impurity testing performed by Umed on:

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