Application note: Testing and validation of various antacids for class 1 and 2A elemental impurities

In this paper, PerkinElmer present data to illustrate the successful validation of the NexION® 2000 ICP Mass Spectrometer for the determination of Class 1 and 2A elemental impurities in antacids according to USP General Chapter <233>…

The United States Pharmacopeia (USP) has announced that its new standards for elemental impurities in drug products will be implemented on January 1, 2018. General Chapters <232> and <2232> specify the list of elements and their permissible daily exposure (PDE) limits based on the route of administration.

USP has now harmonized the list of elemental impurities, as well as their PDEs, with the International Conference on Harmonization (ICH) Q3D Step 4 document. In June 2016, the FDA issued guidance on elemental impurities covering ICH Q3D in drug products.

As the deadline for assessing and monitoring elemental impurities approaches, pharmaceutical manufacturers and their service laboratories need to act now or risk not being in compliance with the new regulations. Compliance requires that the analytical methodology be capable of accurately measuring low concentrations of elemental impurities in drug products or its components, as necessary, to ensure patient safety.