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

Planta Medica ◽  
2009 ◽  
Vol 75 (04) ◽  
Author(s):  
JM Betz ◽  
LG Saldanha ◽  
KD Fisher ◽  
PM Coates ◽  
M Klein ◽  
...  
Author(s):  
Stephen E. Long ◽  
Michael Ellisor ◽  
Frances Nilsen ◽  
Laura Wood ◽  
Karen Murphy ◽  
...  

2004 ◽  
Vol 87 (1) ◽  
pp. 162-165 ◽  
Author(s):  
Leila G Saldanha ◽  
Joseph M Betz ◽  
Paul M Coates

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.


Planta Medica ◽  
2013 ◽  
Vol 79 (05) ◽  
Author(s):  
JM Betz ◽  
LG Saldanha ◽  
G Cragg ◽  
B Sorkin ◽  
PM Coates

2013 ◽  
Vol 27 (S1) ◽  
Author(s):  
Joseph M Betz ◽  
Leila G Saldanha ◽  
Gordon L Cragg ◽  
Barbara C Sorkin ◽  
Paul M Coates

2007 ◽  
Vol 389 (1) ◽  
pp. 19-25 ◽  
Author(s):  
Joseph M. Betz ◽  
Kenneth D. Fisher ◽  
Leila G. Saldanha ◽  
Paul M. Coates

2007 ◽  
Vol 90 (4) ◽  
pp. 934-940 ◽  
Author(s):  
Jeanice B Thomas ◽  
Katherine E Sharpless ◽  
Staci Mitvalsky ◽  
Mark Roman ◽  
James Yen ◽  
...  

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.


1992 ◽  
Vol 56 (384) ◽  
pp. 289-308 ◽  
Author(s):  
Louis J. Cabri

AbstractData on the distribution of the precious metals (Au, Ag and the platinum=group elements Ru, Rh, Pd, Os, Ir, Pt) are rapidly accumulating as a consequence of the application of microbeam analytical techniques such as the electron microprobe, the proton microprobe, and the ion microprobe. The new data obtained with these techniques build on knowledge accumulated over the last 140 years using bulk analytical methods (e.g. spectrographic). The nature of the occurrence, the concentrations, and the variation in amount s of precious metals in minerals and mineral products are reviewed with comments as to the significance of the results with respect to industrial and environmental concerns. Future directions in mineral-specific analysis of trace precious-metal concentrations and applications outside of process mineralogy are discussed.


1989 ◽  
Vol 72 (1) ◽  
pp. 1-5
Author(s):  
Alex Williams

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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