Editors’ Series: Quality Control of Dietary Supplements: An Examination of Chromatographic Approaches Needed for cGMP Compliance, with Case Studies

This presentation was recorded on November 05, 2014.


The dietary supplement industry has grown to become a multibillion-dollar-a-year market. Concurrent with this growth, the FDA has implemented new current good manufacturing practices (cGMP) regulations (21 CFR part 111) that mandate appropriate quality control and process control testing for dietary supplements, from incoming materials to finished goods. One of the most important tools used in quality control of dietary supplements is chromatography. Everything from high performance thin-layer chromatography to high resolution gas chromatography–mass spectrometry (GC–MS) and liquid chromatography–mass spectrometry (LC–MS) techniques are employed to deal with what some are now calling the most complex sample matrices ever encountered. This presentation will review what these new regulations mean to companies in regard to testing requirements and what types of chromatography systems are utilized to address the issues, and will provide examples of various actual sample analyses using a host of separation science platforms. The attendee will have a better understanding of the massive scope of instrumentation needed just within the realm of separation science to meet new federal regulations.

Part of a new web seminar series organized by, and in collaboration with, the Pacific Southwest Section of AOAC International

Editors’ Series: The Use of Silica Hydride-Based Stationary Phase for the HPLC Analysis of Food and Beverage Products

James Neal-Kababick
Flora Research Laboratories

Meg L'Heureaux
Managing Editor

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