Alternative sample preparation and analysis approach for ICH/USP controlled metals by ICP-MS

Application Note Pharmaceuticals Determining Elemental Impurities in Pharmaceutical Ingredients using ICP-MS USP/ICH methodology used to measure 24 elemental impurities in raw materials dissolved in DMSO Authors Radhey S. Dhuria, Vinay Jain, Gaurav Kapadnis and Samir Vyas Agilent Technologies, Inc. Introduction…

Application Note Pharmaceuticals Validating performance of an Agilent ICP‑MS for USP <232>/<233> & ICH Q3D(R2)/Q2(R1) Reducing the time and expense of ICP-MS method development and system validation for measuring elemental impurities in pharmaceuticals Authors Lindsey Whitecotton, Ed McCurdy, Craig Jones…

White Paper USP <232>/<233> and ICH Q3D Elemental Impurities Analysis: The Agilent ICP-MS Solution Elemental Impurity Analysis Requirements Worldwide, regulatory authorities are responsible for ensuring that pharmaceutical products are both effective and safe. Potentially toxic and harmful contaminants—including elemental impurities—must…

Proposed new ICH and USP methods for elemental impurities: The application of ICP-MS and ICP-OES for pharmaceutical analysis White paper Authors Amir Liba, Ed McCurdy and Ross Ashdown Agilent Technologies Abstract The United States Pharmacopeial Convention (USP), in parallel with…