Elemental Impurity Studies
Elemental impurities in pharmaceuticals may originate from several sources in the manufacturing process. Impurities into drug products 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.