The simple alternative to ICP-MS for elemental impurity analysis in pharmaceutical products

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00:00:00 Welcome
00:01:03 Poll Questions
00:01:03 Introduction
00:02:22 Poll Answers
00:02:22 Content of this webinar
00:02:56 USP chapters <232/233>
00:04:10 Elemental impurities in pharmaceutical drugs
00:05:52 ICH Q3D
00:06:07 ICH Q3D
00:07:28 ICH Q3D
00:09:07 Elemental impurity control by ICP
00:11:25 USP chapters <232/233>
00:11:57 X-ray fluorescence spectrometry
00:13:07 Current Analysis
00:15:40 Advantages of XRF
00:17:19 Developments in EDXRF
00:19:09 Epsilon 4
00:20:39 Easy installation
00:21:02 Pharmaceutical standards
00:23:00 Sample preparation
00:23:49 Easy measurement procedure
00:24:16 Application set up
00:25:41 Limit of Quantification for Group 1, 2A & 2B
00:27:43 Accuracy
00:28:54 Accuracy
00:29:29 Accuracy
00:29:47 Enhanced software options for pharmaceutical industry
00:31:22 Summary
00:32:16 Summary
00:33:22 Thank you for your interest
The introduction of USP<232> and ICH Q3D requires the pharmaceutical industry to re-evaluate how elemental impurity (heavy metal) testing is performed.  ICP-MS is often used for this type of analysis, but requires a high level of user expertise and can be time-consuming.  USP <735> and EP 2.2.37 enable the use of X-ray fluorescence (XRF) spectrometry as an alternative technology for pharmaceutical elemental impurity testing.  In this webinar, the capabilities of the Epsilon 4 benchtop system set up with our unique calibration solution to analyze elemental impurities according to current regulatory requirements, will be demonstrated.