Reprinted with permission from www.NutraIngredients-usa.com, April 26, 2005
NOW Foods’ glucosamine HPLC method has passed the AOAC’s 2-year validation process to become the first action official method for testing the standards of the joint health ingredient.
Called “Determination of Glucosamine in Raw Materials and Dietary Supplements Containing Glucosamine Sulfate and/or Glucosamine Hydrochloride by HPLC with FMOC-Su Derivatization”, the method was selected by the expert review panel in April 2003 as the best method for further laboratory validation. Its success in this means it will be published in the Journal of AOAC International and become available to the industry this summer.
"Having NOW's method for glucosamine become the official AOAC method is a testament to the expertise of our staff, our focus on the science, and our commitment to quality,” said Michael Lelah, technical director of NOW Foods.
The standard for glucosamine, a shrimp-meat by-product, is one of 25 validated analytical methods being drawn up by the not-for-profit scientific association’s Dietary Supplements Task Force as part of its five-year contract with the National Institutes of Health, Office of Dietary Supplements, and the FDA’s Center for Food Safety and Applied Nutrition.
The need for globally acceptable analytical standards was identified since, although standards exist for some ingredients in certain markets, they are not necessarily consistent with each other. Internationally-recognized standards give the industry a point of reference in case of dispute.
The contract expires next year, but earlier this month NutraIngredients-USA.com reported that some industry members are keen to see the program extended to more ingredients. But with AOAC’s cost for developing a standard for a single ingredient amounting to more than $150,000, funding for this would have to be sourced from the industry itself.
03.11.05--AOAC Expert Review Panel Selects NOW's Chondroitin Sulfates Analytical Method
By Joseph Zhou, Ph.D., Director of Laboratory Methods, NOW Foods
“AOAC INTERNATIONAL is a 120 year-old not-for-profit scientific association committed to worldwide confidence in analytical results. AOAC serves the communities of analytical sciences by providing the tools and processes necessary for community stakeholders to collaborate and, through consensus building, develop fit-for-purpose methods and services for assuring quality measurements.”
In other words, AOAC is an international organization that validates measurement and testing methods for industry. It is a tribute to the professional standards of the NOW laboratory staff when a method developed in our lab is accepted as an industry standard.
In addition to NOW’s Glucosamine analytical method that will shortly become an AOAC Official Method, our Chondroitin Sulfates (CS) method has also been chosen by the AOAC Expert Review Panel (ERP) on CS as the most appropriate method to recommend for further laboratory validation. Scientists from three industry labs (NOW Foods, ChromaDex and Analytical Laboratory in Anaheim, Inc.,) are currently working together under AOAC guidance to perform the first step of the AOAC Official Method Validation Program: Single Laboratory Validation (SLV).
The AOAC Official Method Program is the result of a contract between the Center for Food Safety and Applied Nutrition, FDA and the Office of Dietary Supplements, NIH with AOAC INTERNATIONAL. The purpose of the contract is to provide the FDA, other government agencies, and the dietary supplements industry with AOAC Official Methods applicable to commercially available dietary supplements and raw materials.
The current USP CPC (Cetyl Pyridinium Chloride) titration method to test CS has poor selectivity. In principle, all sulfated and non-sulfated glycosaminoglycans, proteins, dextran sulfate, and surfactants with suitable molecular weight as polyanion score positively in the CPC titration. This means that this method may measure more than just chondroitin sulfates and thus incorrectly give a higher reading than the actual.
The real concern, however, is that some CS raw materials may contain unwanted glycosaminoglycans, such as heparin, heparan sulfate, and dermatan sulfate. Products containing these impurities in a significant amount may carry negative health implications. Heparin, for example, is a drug, used as an important anticoagulant in medicine. Unfortunately, the CPC titration can not differentiate between heparin and CS. Thus, the USP measurement clearly needs to be updated with a more accurate method.
In contrast, NOW’s CS analytical method is an enzymatic HPLC (High Performance Liquid Chromatograph) method. It is an extremely selective (only to CS) and accurate method, simply because both the specific enzyme and the modern HPLC separation technique are used. The peaks of CS and other compounds are identified, and can be visually seen on its chromatogram. Thus the method is recognized as the safest method for evaluation of both CS raw material and finished products.
NOW’s accomplishments in both Glucosamine and CS methods, as well as our published SAMe method in the Journal of AOAC International (Vol. 85, No. 4, 2002), demonstrate not only NOW’s commitment to quality testing and outstanding product quality, but our commitment to be a leader in product quality as well.
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