Meeting USP Guidelines for Elemental Impurity Analysis with X-ray Fluorescence Spectrometry
The author discusses how x-ray spectrometry can be an effective way to measure these impurities and meet regulatory guidelines.
In sufficiently high concentrations, elemental impurities, typically from catalyst residue, can pose safety risks. The author discusses how x-ray spectrometry can be an effective way to measure these impurities and meet regulatory guidelines.
Read this articlefrom Pharmaceutical Technology’s 2016 Solid Dosage Drug Development and Manufacturing eBook.
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2016 Solid Dosage Drug Development and Manufacturing eBook.
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
