Preparation and Characterization of a Suite of Ephedra-Containing Standard Reference Materials

The National Institute of Standards and Technology, the U.S. Food and Drug Administration, Center for Drug Evaluation and Research and Center for Food Safety and Applied Nutrition, and the National Institutes of Health, Office of Dietary Supplements, are collaborating to produce a series of Standard...

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Bibliographic Details
Published in:Journal of AOAC International 2006-11, Vol.89 (6), p.1483-1495
Main Authors: Sharpless, K.E, Anderson, D.L, Betz, J.M, Butler, T.A, Capar, S.G, Cheng, J, Fraser, C.A, Gardner, G, Gay, M.L, Howell, D.W
Format: Article
Language:English
Subjects:
alkaloids
Alkaloids - analysis
Biological and medical sciences
Cadmium - analysis
caffeine
Calcium - analysis
Carbohydrates - analysis
Center for Food Safety and Applied Nutrition
Dietary supplements
Dietary Supplements - analysis
Ephedra
Ephedra - chemistry
Ephedra - radiation effects
Fatty Acids - analysis
food composition
Food industries
Fundamental and applied biological sciences. Psychology
General aspects
Humidity
Identification and classification
Methods of analysis, processing and quality control, regulation, standards
nutrient content
product authenticity
protein content
proximate composition
Reference Standards
Reproducibility of Results
standards of identity
toxic substances
Trace Elements - analysis
Vitamins - analysis
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Summary:The National Institute of Standards and Technology, the U.S. Food and Drug Administration, Center for Drug Evaluation and Research and Center for Food Safety and Applied Nutrition, and the National Institutes of Health, Office of Dietary Supplements, are collaborating to produce a series of Standard Reference Materials (SRMs) for dietary supplements. A suite of ephedra materials is the first in the series, and this paper describes the acquisition, preparation, and value assignment of these materials: SRMs 3240 Ephedra sinica Stapf Aerial Parts, 3241 E. sinica Stapf Native Extract, 3242 E. sinica Stapf Commercial Extract, 3243 Ephedra-Containing Solid Oral Dosage Form, and 3244 Ephedra-Containing Protein Powder. Values are assigned for ephedrine alkaloids and toxic elements in all 5 materials. Values are assigned for other analytes (e.g., caffeine, nutrient elements, proximates, etc.) in some of the materials, as appropriate. Materials in this suite of SRMs are intended for use as primary control materials when values are assigned to in-house (secondary) control materials and for validation of analytical methods for the measurement of alkaloids, toxic elements, and, in the case of SRM 3244, nutrients in similar materials.
ISSN:1060-3271
1944-7922
DOI:10.1093/jaoac/89.6.1483