Proposed new ICH and USP methods for elemental impurities: The application of ICP-MS and ICP-OES for pharmaceutical analysis

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…

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

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…

Measuring Elemental Impurities in Pharmaceutical Materials Agilent Atomic Spectroscopy Solutions USP <232>/<233> & ICH Q3D(R2)/Q2(R1) Implementing Elemental Impurities Tests in the Pharmaceutical Industry Worldwide regulations for pharmaceutical materials Worldwide pharmacopeias have introduced revised standards for controlling elemental impurities in drug…