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With the advent of new Good Manufacturing Practices (GMPs) for dietary supplements, per the reportedly imminent publication of final GMP regulations from FDA, many manufacturers are increasingly seeking new methods, tools, and materials in increase the documentation of identity and quality of botanical materials.
One tool needed for proper botanical and chemical quality assessments is reference standards and reference materials for use in calibrating laboratory analytical equipment and other laboratory methods. [For a cogent introduction to this subject, please see article in HerbalGram 63.] 1
To aid herb and dietary supplement companies in this process, ChromaDex, Inc., of Santa Ana, CA, has launched a new line of botanical reference materials (BRMs) that the company claims are breakthroughs for the dietary supplement industry. 2
BRMs are well-characterized reference materials for specific plants. The characterization of BRMs includes macro and microscopic information for a specific genus and species of plant. Many of Chromadex’s BRMs include Thin Layer Chromatograms, produced according to thin-layer chromatography (TLC). These chromatograms represent chemical “fingerprints” of the botanical. The BRMs also include certified identity and the source of the plant to further assist in the evaluation.of the botanical material. BRMs come with the documentation necessary to judge the plant material and to assess the evaluative approach. BRMs give users the tools necessary to know that their botanical raw material evaluation is comprehensive while affording them the opportunity to begin assessment of the material’s composition.
Along with ChromaDex Chemical Reference Standards (CRSs), BRMs provide the tools necessary to develop and apply scientifically valid analytical methods to botanical products used in the dietary supplement industry.
“BRMs are very exciting, exclusive additions to our product portfolio,” said Frank Jaksch, Jr., Chief Executive Officer of ChromaDex. “BRMs represent a quantum leap in methods development and evaluation for botanical products. Now our customers have the tool set they need (BRMs and CRSs) for assurance today and compliance tomorrow with the upcoming GMPs for dietary supplements. These new product line launches offer our customers a complete range of analytical tools to evaluate botanical products from biomass to bottle.” 2
As with Chromadex’s CRSs, the BRMs contain the analytical methods used to make the determinations found in the Certificate of Analysis (including all necessary information, including the methods for macroscopic, microscopic and TLC [thin-layer chromatograpy] identification, including images for each).
ChromaDex, Inc. is a privately-held company and is widely considered a leader in the development and distribution of dietary supplement and botanical reference standards. The company also has developed strategic relationships with Bayer Innovation, a subsidiary of Bayer AG, Phyto-Technologies, Cerilliant, and American Herbal Pharmacopoeia to provide the dietary supplement, functional foods, nutraceutical and cosmetic industries with analytical tools, products, and methods to meet the regulatory, quality, efficacy and safety standards for their products. More at www.chromadex.com.
--Mark Blumenthal
References
1. Reif K, Sievers H, Steffen J-P. The Role of Chemical Reference Standards as Analytical Tools in the Quality Assessment of Botanical Materials- A European Perspective. HerbalGram. 2004;63:38-43.
2. ChromaDex launches new line of botanical reference materials. [press release]. Santa Ana, CA: ChromaDex Inc., Dec. 12, 2005.
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