Determination of Elemental Impurities in Antacids by ICP-MS According to the Validation Protocols Defined in USP Chapters <232> and <233> and ICH Q3D Step 4 Guidelines

摘要

This study focuses on the determination of a suite of Class 1 and 2A elemental impurities (Pb, As, Cd, Hg, Co, Ni, and V) in various over-the-counter antacid tablets by inductively coupled plasma mass spectrometry (ICP-MS), as defined in the United States Pharmacopeia (USP) Chapter <232> and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Step 4 Guidelines. The analysis is performed according to the recommended sample preparation procedure and validation protocols laid out in USP Chapter <233>, by optimizing both the microwave digestion procedure and the analytical methodology for these types of sample matrices that contain extremely high levels of calcium, magnesium, and other mineral components.