PerkinElmer
Testing and Validation

Application Note

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

CONTROL OF IMPURITIES Testing and Validation

Introduction

The United States Pharmacopeia (USP) has announced that its new standards for elemental impurities in drug products has been implemented since 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.