Recent Topics Posters
Betz, Joseph M. , Fisher, Kenneth D. , Saldanha, Leila G. , NguyenPho, Agnes , Sharpless, Katherine E. , Sander, Lane C. , Wise, Stephen A. , Roman, Mark C. .
General Considerations for the Production of Identity Reference Materials for Botanical Dietary Supplements and Natural Health Products.
Over the past decades there has been an increase in biomedical research on Natural Products. Funding agencies have demanded that researchers adequately describe study materials in order to ensure that ethical standards and scientific principles are maintained. Difficulties in characterization persist because of the complexity of the products. Raw materials are invariably "irregular" because their chemical composition depends on factors such as geographical origin, weather, harvesting practices, etc. In 2002, the Office of Dietary Supplements (ODS) established an Analytical Methods and Reference Materials Program. Stakeholders identified needs for identity standards, calibration standards, and matrix reference materials (MRM). In response to these recommendations, ODS has sponsored research on production of pure compounds and for manufacture of high purity materials. The ODS has also sponsored development of matrix reference materials (MRM). This part of the program has been conducted in partnership with the National Institute of Standards and Technology (NIST). Briefly, MRM are produced as suites for which certified values for selected chemical constituents are established. Each suite consists of dried, powdered biomass, an extract, and one or more representative commercial products. Work on botanical identity standards has been deferred pending consensus on the characteristics of such materials and the establishment of a process for the validation of identity tests. Raw materials in the marketplace range from cut and sifted plants to powdered biomass to extracts spray-dried onto a carrier. Most of the plants in commerce are not harvested when the plant is in flower and many commercial raw materials utilize plant parts such as roots and rhizomes, thus classical techniques for plant identification may be useless. In such cases, phytochemical profiling may be necessary to establish identity. Requirements of a “certified” reference material will be described along with the unique difficulties associated with the production of certified botanical identity reference materials.
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1 - National Institutes of Health, Office of Dietary Supplements, 6100 Executive Blvd. Room 3B01, Room 3B01, Bethesda, MD, 20892, USA
2 - U.S. Food and Drug Administration, Center for Drug Evaluation and Research, White Oak Office Building #22, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA
3 - National Institute for Standards and Technology, 100 Bureau Drive, Stop 8390, Gaithersburg, MD, 20899-8390, USA
4 - Tampa Bay Analytical Research, Inc., 10810 72nd St., STE 206, Largo, FL, 33777, USA
Identity Reference Materials
Certified Reference Materials
Herbal dietary supplement
Natural Health Products
Presentation Type: Recent Topics Poster
Location: Ball Room & Party Room/SUB
Date: Monday, July 28th, 2008
Time: 12:30 PM