Setting meaningful and realistic specifications for pharmaceutical product Critical Material Attributes (CMAs) is important in ensuring a product meets its target performance profile and is safe. Within this, control of elemental impurities is vital as these do not provide therapeutic benefit to the patient and may even cause an adverse effect.
This webinar series will consider the requirements for elemental analysis for pharmaceutical intermediates and final dosage forms and how X-Ray Fluorescence (XRF) offers a simple, robust alternative to existing methods such as ICP-OES, ICP-MS and AAS.
In this first presentation, we will consider why elemental analysis is required. We’ll review the guidance provided in ICH Q3D, which recommends analysis of elements which 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). We will then examine the guidance provided in USP +lt;735>and EP 2.2.37 for the use of XRF and consider how it can be realistically applied for rapid characterization of pharmaceutical intermediates and dosage forms.
The second seminar in the series will consider how an appropriate method for XRF elemental analysis can be developed, including a live demonstration of the use of the technique.