AOAC INTERNATIONAL to Validate Analytical Method for Coenzyme Q10 (Ubidecarenone, Ubiquinol-10)

In an effort to develop a standardized testing method for Coenzyme Q10, AOAC INTERNATIONAL’s industry working group on CoQ10, Chaired by Barry Titlow, Compound Solutions, issued a call for methods and collected 15 methods for the determination of CoQ10 in dietary supplements. Subsequently, an Expert Review Panel (ERP), composed of 10 experts representing government (FDA), industry, and organizations (USP), was carefully selected to act as an independent 3rd party review panel and to choose the best method for further validation based on selection criteria developed by the ERP.

The ERP, chaired by Kelly Reins of Soft Gel Technologies, Inc. met in February 2005 and selected an unpublished method submitted by M. Abdelbarr of Tishcon, which was a modification of the USP method for CoQ10. However, the Panel also concluded that the method needed extensive modification. Steve Lunetta of Pharmavite undertook the method development work, which has now been completed. The report of the development effort is currently being peer reviewed by the ERP.

The method is applicable to all raw materials and processed finished products containing CoQ10. It includes an oxidation step to insure that all of the CoQ10 is in the oxidized form, followed by HPLC/UV quantitation. Although CoQ9 and the cis form of CoQ10 are well separated chromatographically, they are not quantitated, the latter for lack of a suitable reference material.

Jules Shamarack of Eurofins will be the Study Coordinator for the Single Laboratory Validation (SLV) study. Prior to the study, Mr. Shamarack will develop the method Protocol, which will then need AOAC peer review and approval prior to the study being conducted sometime this summer. If successful, the method will undergo full collaborative study involving 8 – 10 laboratories to achieve AOAC Official MethodsSM status.

AOAC INTERNATIONAL is an independent, not-for-profit scientific association dedicated to the development and validation of analytical standards. Currently, AOAC is working under contract with the National Institutes of Health/FDA and with the dietary supplement industry to get inferior products off the market through sound, validated testing methodology. AOAC has developed standardized testing methods, validated through collaborative study, for ephedra, beta-carotene, glucosamine, and is nearing completion of standardized tests for ginkgo, saw palmetto, omega-3 and 6 fatty acids, chondroitin, SAMe, and others, with the goal of validating 20 analytical methods over a five-year period.

Considering that there are more than 3,000 dietary supplement ingredients and more than 40,000 products in which they appear, AOAC is looking to industry to play a significant role in speeding up this process through engagement and infrastructure support.

To participate in the collaborative study of CoQ10 or to find out more about AOAC dietary supplement program, contact Anita Mishra, Principal Scientific Liaison, Government and Industry, AOAC INTERNATIONAL, [email protected], telephone: 301 924-7077, ext. 131.

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