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AMRM Program Areas
AMRM is organized under three main program areas:
The Office of Dietary Supplements' support of analytical method development is generally funded through interagency agreements (IAG) with US Government entities such as US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA). Methods development to identify and classify botanicals through chemical fingerprinting and non-targeted approaches is funded through an IAG with the USDA Methods and Application of Food Composition Laboratory. The main approach to validating methods prior to 2012 was through an IAG with FDA to continue and expand an existing contract with AOAC International. From 2013 to 2018, ODS contracted with AOAC International to develop and support prioritization and standard-setting activities for the validation of analytical methods and establishment of publicly-available Official Methods of AnalysisSM. AMRM currently supports the validation studies of analytical methods for the quantification of dietary supplement constituents and metabolites through the NIH Funding Opportunity Announcement NOT-OD-22-202.
Reference materials (RMs) are critical tools for establishing the accuracy, precision, and reliability of analytical measurements. Natural matrix RMs funded by AMRM are produced primarily by the National Institute of Standards and Technology (NIST). NIST acquires authenticated materials, such as plant parts used for botanical ingredients or formulated dietary supplement products, and performs chemical analysis for pre-defined chemicals of interest. When completed and available, the reference materials are accompanied by a Certificate of Analysis that lists the quantities of each measured constituent, along with a statement of the measurement uncertainty. When the amounts of constituents in a product can be verified by multiple techniques and multiple laboratories, NIST gives these certified reference materials the Standard Reference Material® (SRM) designation, indicating the material is a NIST certified reference material (CRM). Calibration solution CRMs supported by AMRM are pure compounds or defined mixtures of pure compounds intended to be used to establish analyte identity and for instrument calibration. Through AMRM funding, NIST continues to expand its catalog of SRMs intended to aid in dietary supplement characterization and research.