AOAC a step closer to CoQ10 testing method

Related tags Food and drug administration

The AOAC has completed modifications to a proposed analytical
method for co-enzyme Q10 and validation studies are expected to get
underway this summer, reports Jess Halliday.

The selected method, submitted by Tishcon's M. Abdelbarr, was a modification of the United States Pharmacopoeia's method. But the expert review panel judged that further development, undertaken by Steve Lunetta of Pharmavite, was required.

The method can be used to analyze 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, and HPLC/UV quantitation.

Jules Shamarack of Eurofins is in the process of developing a method protocol, which must be peer reviewed by the AOAC​ before the single laboratory validation study (to be carried out by Shamarack) can begin this summer.

If Shamarack's study is successful, the method will progress to a full collaborative study involving eight to 10 laboratories.

Barry Titlow, CEO of Compound Solutions​ and chairman of the AOAC's CoQ10 standards committee told NutraIngredients-USA.com in April that there is a need for globally acceptable CoQ10 standards since, although analytical standards already exist in Japan, US and the EU, they are all slightly different.

While US companies were requiring standards, they were modifying those set by organisations such as the US Pharmacopoeia to suit their own needs and machinery - a situation leading to a good deal of variation.

"Our mission was to develop a method for CoQ10 analysis that would be accepted globally and could be implemented using standard machinery,"​ said Titlow.

CoQ10 has become an increasingly popular ingredient in recent years thanks to a study indicating that it may be of benefit to Parkinson's patients, its use in anti-aging formulations and regulatory changes for its use in food supplements in Japan.

The development of a CoQ10 validation method is part of the AOAC's Dietary Supplements Task Force program, which secured funding in September 2001 to develop standards for 20 ingredients through a five-year contract between the AOAC, National Institutes of Health (NIH), Office of Dietary Supplements (ODS), and the FDA's Center for Food Safety and Applied Nutrition.

Methods have already been drawn up and validated for ephedra, beta-carotene and glucosamine and standardized tests for ginkgo, saw palmetto, omega-3 and 6 fatty acids, chondroitin and SAMe are among those nearing completion.

In April Titlow called on the industry to contribute towards extending the program beyond the contract's end next year, saying a "tremendous opportunity"​ exists for the industry to improve core practices.

"We want to prevent government enforcement by coming up with standards, so it is impressed with the industry's self-regulation,"​ he said.

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