Introduction
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 administration1. USP has now harmonized the list of elemental impurities, as well as their PDEs, with the International Conference on Harmonization (ICH) Q3D Step 4 document2. In June 2016, the FDA issued guidance on elemental impurities covering ICH Q3D in drug products3.
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.
>> Download the full Application Note as PDF
Newsletters
Receive the latest analytical scientist news, personalities, education, and career development – weekly to your inbox.
