Accuracy, precision and reliability in natural product analysis: mechanisms of NIH support for methods development and validation

Reproducible biomedical and nutritional research on natural products requires precise, accurate and rugged methods of analysis. Reliable and appropriate calibration standards are indispensible for verification of product identity, for quantification of analytes of interest in products or biospecimens, and for determination of contaminants; they are thus equally critical for manufacturers and regulators.

NIH supports the development and validation of methods and reference materials for natural product analysis through the Office of Dietary Supplements' Analytical Methods and Reference Materials Program (AMRM). This stakeholder-driven Program includes collaborations with other government agencies, researchers and the private sector to develop validated reference materials, standards, and analytical methods, and to disseminate them to the relevant communities. Among the projects supported by the AMRM to date are: 1) development of chemical reference materials for half a dozen botanicals and for multi-vitamin supplements, 2) publication of 16 AOAC (Association of Analytical Communities) Official Methods of Analysis, 3) development of 20 matrix standard reference materials that are available from the US National Institute of Standards and Technology and 4) publication of validation studies of more than 20 methods for botanicals or botanical components. Recently the AMRM Program has added supplemental funding for NIH awardees to validate analytical methods developed in support of a parent award.

This presentation will provide a brief overview of the AMRM Program and demonstrate the effects of appropriate methodology on analytical results.