| 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.