开始:VCALENDAR版本:2.0 PRODID: - / /乔迪实验室乐动体育登录ECPv5.1.0//NONSGML v1.0//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:Jordi Labs X-ORIGINAL-URL://m.buyjuzo.com X-WR-CALDESC:Events for Jordi Labs BEGIN:VTIMEZONE TZID:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:20210314T070000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:20211107T060000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=America/New_York:20210715T110000 DTEND;TZID=America/New_York:20210715T120000 DTSTAMP:20220214T105235 CREATED:20210517T202839Z LAST-MODIFIED:20210517T203455Z UID:57296-1626346800-1626350400@m.buyjuzo.com SUMMARY:Webinar: The Multidetector Approach DESCRIPTION:\n\n\nDr. Weixi Liu will present “The Multidetector Strategy for Reducing Response Factor (RF) Variation in E&L Analysis.” \n\n\n\nChemical characterization per ISO 10993\, and <1664> has become an important component of testing of medical devices and drug products. A major concern regarding the accuracy of extractables and leachables studies is quantitative error due to response factor (RF) variation. Recent publications have highlighted the risks posed by RF variation for both LCMS (Jordi et al. Journal of Pharmaceutical and Biomedical Analysis 150 (2018) 368–376) and GCMS (Jenke and Odufu\, Journal of Chromatographic Science 2012;50:206–212). The importance of this issue has been recognized by the FDA resulting in the addition of an uncertainty factor (UF) in the calculation of the analytical evaluation threshold (AET). \n\n\n\nIn this presentation\, an alternative strategy for quantitation using a multidetector strategy including a liquid chromatography system with mass spectroscopy (LCMS)\, ultraviolet (UV) and charged aerosol detection (CAD) as well as a Gas Chromatography system using mass spectroscopy (MS) and Flame Ionization Detection (FID) will be presented. Data comparing the response factors for more than 200 extractables will be presented demonstrating an approach to reduce overall RF variation. This reduced the associated need for UFs and increases confidence in the resulting risk assessments. \n\n\n\nKey Learning Objectives: \n\n\n\nLearn how the Multidetector Strategy addresses the problem of underreporting at the Analytical Evaluation Threshold (AET)Understand why the Multidetector Strategy provides for improved quantitative accuracyUnderstand the advantages and limitations of Response Factor (RF) databases\n\n\n\n\n\n\n\n\n\n\n\n\n URL://m.buyjuzo.com/event/webinar-the-multidetector-approach/ CATEGORIES:Extractables, Leachables and Elemental Impurities ATTACH;FMTTYPE=image/png://m.buyjuzo.com/wp-content/uploads/2021/05/image-47.png END:VEVENT END:VCALENDAR