Setting meaningful and realistic specifications for pharmaceutical product Critical Material Attributes (CMAs) ensures that products are safe and meet their target performance profile. To achieve this, it is vital to control elemental impurities as these do not provide any therapeutic benefit to the patient and may even cause an adverse effect.
Join this webinar to learn about the requirements for elemental analysis for pharmaceutical intermediates and final dosage forms and discover how X-Ray Fluorescence (XRF) provides a simple and robust alternative to ICP-OES, ICP-MS and AAS. Our expert in XRF technology, Dr. Lieven Kempenaers, will show how you can make the invisible visible with XRF analysis.
During the course of this webinar, you will:
- explore why elemental analysis is required
- review and understand how to apply the guidance of ICH Q3D, which recommends analysis of elements that may be present as impurities, either from processing or raw materials, or may have been intentionally added during processing (such as heavy metal catalyst materials)
- examine the guidance provided in USP <735> and EP 2.2.37 for the use of XRF
- consider how to apply the guidance for rapid characterization of pharmaceutical intermediates and dosage forms
Lieven Kempenaers - Product Manager XRF - Malvern Panalytical
Who should attend?
- Anyone developing methods for elemental analysis, for example using ICP, AAS or XRF.
- Anyone developing pharmaceutical formulations
- Anyone producing or setting specifications for pharmaceutical raw materials or intermediates
What will you learn?
- Learn about why elemental analysis is important for pharmaceutical products.
- Understand the regulatory guidance relating to elemental analysis.
- Learn about the application of XRF and how this compares to techniques such as ICP and AAS.