Control of elemental impurities in pharmaceutical products is vital for ensuring they are safe and do not cause harm to patients.
The removal, or scavenging, of impurities introduced during processing is therefore critical throughout development, scale-up and manufacture. This requires access to relevant methods for elemental analysis which can rapidly inform process development and, ultimately, provide process control.
This webinar will consider the requirements for elemental analysis for pharmaceutical intermediates and final dosage forms and show how X-ray fluorescence (XRF) offers a simple, robust and more cost-effective alternative to existing methods such as ICP-OES, ICP-MS and AAS.
In this webinar, we’ll review the guidance provided in ICH Q3D regarding the detection and analysis of elements which may be present as impurities, either from processing or raw materials, or which may have been intentionally added during processing (such as heavy metal catalyst materials). We’ll then examine the guidance provided in USP and EP 2.2.37 for the use of XRF and show how it can be realistically applied for rapid characterization of pharmaceutical intermediates and dosage forms.