Elemental impurities may arise from residual catalysts that were added intentionally in synthesis, or may be present as impurities, e.g., through interactions with processing equipment or container/closure systems or by being present in components of the drug product.
The analytical procedure for Elemental Impurities implemented in our lab, ICP-MS analysis after microwave assisted digestion, allows the accurate determination of the elements defined in ICH Q3D guidelines and the additional ones required by EMA.
