Focus on Pharma: Elemental Analysis - Simplify your Workflow

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00:00:00 Welcome
00:00:12 Introduction
00:01:41 Focus on PharmaElemental analysis: Simplify your workflow 
00:02:05 Content of this webinar
00:02:54 USP chapters <232/233>
00:04:43 USP chapters <232/233>
00:05:20 Elemental impurities in pharmaceutical drugs
00:06:26 ICH Q3D
00:06:44 ICH Q3D
00:07:53 ICH Q3D
00:09:59 Elemental impurity control by ICP
00:12:32 USP <735>
00:13:15 X-ray fluorescence spectrometry
00:15:03 Current Analysis
00:18:43 Advantages of XRF
00:21:37 Easy installation
00:22:20 Developments in EDXRF
00:24:01 Epsilon 4
00:24:58 Pharmaceutical standards
00:26:02 Sample preparation
00:27:03 Easy measurement procedure
00:27:43 Application set up
00:28:33 Limit of Quantification for Group 1, 2A & 2B
00:29:45 Accuracy
00:30:29 Accuracy
00:30:47 Accuracy
00:31:27 Enhanced software options for pharmaceutical industry
00:33:17 Summary
00:34:41 Summary
00:35:48 Thank you for your interest

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.


Lieven Kempenaers Ph.D. - Global Product Manager Benchtop XRF Instruments


- 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.

- Why attend?
To learn about why elemental analysis is important for pharmaceutical products.
To understand the regulatory guidance relating to elemental analysis.
To learn about the application of XRF and how this compares to techniques such as ICP and AAS.