Testing and validation of various antacids for class 1 and 2A impurities in pharmaceuticals following ICH Q3D and USP <232> / <233> using NexION 2000 ICP-MS
The United States Pharmacopoeia (USP) has announced that its new standards for elemental impurities in medicinal products will be introduced on 1 January 2018. Common Chapters <232> and <2232> define the list of elements and their permissible daily exposure (PDE), restriction based on the method of application1. The USP has already 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 guidelines on elemental impurities covering ICH Q3D in medicinal products3. As the deadline for the assessment and monitoring of impurities approaches, pharmaceutical manufacturers and their service laboratories must act now or risk not complying with the new regulations. Compliance requires the analytical methodology to be able to accurately measure low concentrations of elemental impurities in medicinal products or its components, if necessary to ensure patient safety.