Elemental impurities remain a critical concern in pharmaceutical development and manufacturing, with strict regulatory guidelines outlined in USP <232>, <233>, and ICH Q3D. This presentation explores how X-ray fluorescence (XRF) can be used as a fast, non-destructive tool for identifying and quantifying these impurities. Attendees will gain insight into when XRF is a suitable alternative to traditional techniques like ICP-MS, and how it fits into a compliant analytical workflow. Real-world case studies will highlight both the advantages and limitations of XRF in pharmaceutical environments. Whether you're in R&D or quality control, this session will help you better understand where XRF can add value to your elemental analysis strategy.
Learning Objectives:
Understanding regulatory guidelines outlined in USP <232>, <233>, and ICH Q3D as it relates to elemental impurities and how to develop analytical method
Evaluate the advantages and limitations of X-ray fluorescence
Identify practical applications of XRF across different stages of pharmaceutical development and manufacturing, and determine when it is an appropriate tool for compliance and quality control.
