ICH Q3D Elemental Impurities Analysis of Drug Substances by EDX

Application News No. X278 Shimadzu EDX-7000 Energy Dispersive X-ray Fluorescence Spectrometer Elemental Analysis in Active Pharmaceutical Ingredients (APIs) Development Using EDX: Residual Catalysts, Drug Salts, Contaminants T. Nakao, H. Moriya User Benefits ‹ Chemical pretreatment of APIs is not necessary…

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…

Application Note Pharma & Biopharma Analysis of Artificial Tear Eye Drops For Elemental Impurities Using an ICP-MS and USP <232>/<233> and ICH Q3D(R2)/Q2(R1) protocols. Authors Jennifer Sanderson and Lindsey Whitecotton Agilent Technologies, Inc. Introduction As pharmaceutical products are released to…

Inductively Coupled Plasma Mass Spectrometer ICPMS-2040 Application News Analysis of Pharmaceutical Raw Materials Compliant with ICH Q3D Guideline Using ICP-MS with Collision Mode Yujing Jiang User Benefits  The 24 elements identified in the ICH Q3D guideline can be measured…