The NIH analytical methods and reference materials program for dietary supplements

Abstract The need for validated analytical methods and reference materials to identify and measure constituents in dietary supplements is essential. Such methods allow for the documentation that products meet manufacturer's specifications and contain what their labels declare. In March 2003, the U.S. Food and Drug Administration issued a proposed rule that would establish specific current good manufacturing practices for dietary supplements. This proposed rule requires that companies create a quality control unit to set specifications and ensure compliance with these specifications using scientifically valid procedures. This report provides insights and lessons learned from 3 meetings the Office of Dietary Supplements (ODS) at the National Institutes of Health helped organize. These meetings were structured to (1) educate individuals about the importance and need for validated analytical methods and reference materials to identify and quantify constituents of dietary supplements; (2) identify resources required to fulfill this need; and (3) serve as a platform to obtain input from interested parties to help frame the research agenda for the Dietary Supplements Methods and Reference Materials Program within ODS. Stakeholder's opinions and views expressed at these 3 meetings are outlined in this report.

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The NIH/ODS Analytical Methods and Reference Materials Program for Dietary Supplements: Five-Year Accomplishments and Future Directions

Planta Medica ◽

10.1055/s-2009-1216502 ◽

2009 ◽

Vol 75 (04) ◽

Author(s):

JM Betz ◽

LG Saldanha ◽

KD Fisher ◽

PM Coates ◽

M Klein ◽

...

Keyword(s):

Dietary Supplements ◽

Reference Materials ◽

Analytical Methods ◽

Future Directions

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Analytical methods to characterize recombinant adeno-associated virus vectors and the benefit of standardization and reference materials

Current Opinion in Biotechnology ◽

10.1016/j.copbio.2021.06.025 ◽

2021 ◽

Vol 71 ◽

pp. 65-76

Author(s):

Erica A Green ◽

Kelvin H Lee

Keyword(s):

Reference Materials ◽

Analytical Methods ◽

Adeno Associated Virus ◽

Virus Vectors

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Comparative study of several analytical methods for determination of manganese content in some dietary supplements in Syrian market

Research Journal of Pharmacy and Technology ◽

10.5958/0974-360x.2021.00028.7 ◽

2021 ◽

Vol 14 (1) ◽

pp. 162-166

Author(s):

Maya Tawfik Razzouk ◽

Fidaa Am Ali

Keyword(s):

Comparative Study ◽

Dietary Supplements ◽

Analytical Methods ◽

Manganese Content

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Determination of Caffeine and Caffeine-Related Metabolites in Ephedra-Containing Standard Reference Materials Using Liquid Chromatography with Absorbance Detection and Tandem Mass Spectrometry

Journal of AOAC International ◽

10.1093/jaoac/90.4.934 ◽

2007 ◽

Vol 90 (4) ◽

pp. 934-940 ◽

Cited By ~ 2

Author(s):

Jeanice B Thomas ◽

Katherine E Sharpless ◽

Staci Mitvalsky ◽

Mark Roman ◽

James Yen ◽

...

Keyword(s):

Mass Spectrometry ◽

Liquid Chromatography ◽

Tandem Mass Spectrometry ◽

Dietary Supplements ◽

Reference Materials ◽

Reversed Phase ◽

Oral Dosage ◽

Standard Reference Materials ◽

Tandem Mass ◽

Absorbance Detection

Abstract The concentrations of caffeine and caffeine-related compounds in 2 ephedra-containing reference materials have been determined by 3 independent methods with measurements performed by the National Institute of Standards and Technology (NIST) and a collaborating laboratory. Results from the 3 methods were used for value assignment of caffeine, theobromine, and theophylline in these Standard Reference Materials (SRMs). The methods used at NIST to determine the concentration levels of caffeine, theobromine, and theophylline in SRM 3243 Ephedra-Containing Solid Oral Dosage Form and SRM 3244 Ephedra-Containing Protein Powder used reversed-phase liquid chromatography with absorbance detection and tandem mass spectrometry. These reference materials are part of the first suite in a series of NIST SRMs that provide concentration values for multiple components in dietary supplements. These SRMs are primarily intended for method validation and for use as control materials to support the analysis of dietary supplements and similar materials.

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From Parochial to International

Journal of AOAC INTERNATIONAL ◽

10.1093/jaoac/72.1.1 ◽

1989 ◽

Vol 72 (1) ◽

pp. 1-5

Author(s):

Alex Williams

Keyword(s):

Quality Assurance ◽

Reference Materials ◽

Analytical Methods ◽

Certified Reference Materials ◽

Analytical Measurement ◽

Require Data

Abstract The customers for analytical measurement services have international requirements; they require data of proven validity that will be accepted internationally. This means that well researched and tested analytical methods must gain better international acceptance. The methods should be capable of producing results to the accuracy required by the customer. They need to be supported by the use of appropriate certified reference materials, and the analyst, in reporting results, should give an estimate of the accuracy obtained. In addition, an independent accreditation is needed of the quality assurance procedures of the laboratory to assure customers that the analytical methods have been used correctly.

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