Elemental Impurities

USP <232> and ICH Q3D came into force in January 2018, setting new standards for elemental impurities in drug substances, excipients, and drug products.

Although this guideline sets specifications for drug products only, the risk assessment approach also involves the determination of metallic impurities in APIs and excipients.

In this context, we offer consultancy for risk assessment and state-of-the-art expertise to perform the required analyses (including three generic ICP-MS methods for the determination of all EIs listed in Q3D).