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Application Note

Testing and Validation of Various Antacids for Elemental Impurities using the NexION 2000 ICP-MS

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 administration.