Elemental impurities in pharmaceuticals may originate from several sources in the manufacturing process. Impurities into drug product resulting from elements intentionally added (e.g., catalysts), potentially present in the drug substance/ water/ excipients, introduced from manufacturing equipment, leached from container closure systems.
Determination of elemental impurities in active pharmaceutical ingredients, medicinal products, and raw materials, 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.
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, ICP OES, AAS and samples are processed by both conventional and microwave digestion system.
We perform elemental impurity testing on:
Active Pharmaceutical Ingredients (APIs) / Drug Substance
