ChromaDex, an innovative natural products company that provides proprietary, science-based solutions and ingredients to the dietary supplement, food & beverage, animal health, cosmetic, and pharmaceutical industries, announced on October 29, 2012, that it had been awarded two method validation study contracts from the Office of Dietary Supplements (ODS), National Institutes of Health (NIH). These awards come as part of a contract ChromaDex formed with the General Services Administration (GSA) — Schedule 66: Scientific Equipment and Services, SIN 873-2: Chemical Testing and Analysis Services, Contract Number: GS-07F-0243W, Contract Period: March 1, 2010 to February 28, 2015.
These contracts will be used to create single laboratory validated methods for the quantitative determination of total silymarin content of milk thistle and of total curcuminoid content in turmeric. In addition to having analytical tools to evaluate dietary supplement identity and purity, as mandated by the Current Good Manufacturing Practices (cGMPs) from the Food and Drug Administration (FDA), this also provides a critical factor for assurance of public safety, developing and maintaining quality assurance standards in manufacturing, and for meaningful efficacy testing of these products.
“We are honored to be awarded these contracts by the NIH and ODS, as they provide further recognition of ChromaDex’s phytochemical analytical expertise and the long history of collaboration between ChromaDex and the NIH in the area of dietary supplement reference standards and analytical testing. With the implementation of cGMPs now in full force, the industry needs to have robust analytical methods that they can rely on, such as the ones that will be developed by ChromaDex under the two contracts,” stated Frank Jaksch, CEO and Founder of ChromaDex.
ChromaDex also recently announced that it will partner with Phenomenex, a global leader in the research and manufacture of advanced technologies for the separation sciences, to provide solutions to customers with a combination of reference standards, scientifically valid methods, and application support. The collaboration will combine Phenomenex’s strengths in analytical high-performance liquid chromatography (HPLC) with ChromaDex’s extensive line of reference standards, which are used for quality control in dietary supplement manufacturing. The first three new solutions produced from the collaboration were presented as scientific posters at the Association of Analytical Communities (AOAC) annual meeting in Las Vegas.
Additionally, ChromaDex made a significant breakthrough in September 2012, when it announced findings from its Phase 2/3 trial at the University of Mississippi Medical Center showing that its patented nutritional ingredient pTeroPure® (pterostilbene) significantly reduced blood pressure in adults. Findings from the study, the first clinical trial of the pure compound, were presented on the 20th of September at the American Heart Association’s High Blood Pressure Research 2012 Scientific Sessions. It is worth noting that ChromaDex’s product, pTeroPure®, was the recipient of the 2010 North American Most Promising Ingredient of the Year award by the independent research company Frost & Sullivan. pTeroPure® is a nature-identical form of pterostilbene, an antioxidant found in blueberries.
“We saw reduced overall blood pressure in patients who received the high dose of pterostilbene,” stated Daniel M. Riche, PharmD, Cardiometabolic Clinic Coordinator at the University of Mississippi School of Pharmacy, the study’s principle investigator. “The results of this study highlight that pterostilbene is a promising ingredient in the area of cardiometabolics.”
For more information on ChromaDex, visit www.chromadex.com
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