title: Preparation and characterization of a suite of ephedra-containing standard reference materials.
abstract: 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.
authors.affiliation: National Institute of Standards and Technology, Analytical Chemistry Division, Gaithersburg, MD 20899-8390, USA. katherine.sharpless@nist.gov
authors.forename: Katherine E
authors.initials: KE
authors.lastname: Sharpless
authors.forename: David L
authors.initials: DL
authors.lastname: Anderson
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Betz
authors.forename: Therese A
authors.initials: TA
authors.lastname: Butler
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Capar
authors.forename: John
authors.initials: J
authors.lastname: Cheng
authors.forename: Catharine A
authors.initials: CA
authors.lastname: Fraser
authors.forename: Graeme
authors.initials: G
authors.lastname: Gardner
authors.forename: Martha L
authors.initials: ML
authors.lastname: Gay
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Howell
authors.forename: Toshihide
authors.initials: T
authors.lastname: Ihara
authors.forename: Mansoor A
authors.initials: MA
authors.lastname: Khan
authors.forename: Joseph W
authors.initials: JW
authors.lastname: Lam
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Long
authors.forename: Margaret
authors.initials: M
authors.lastname: McCooeye
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Mackey
authors.forename: William R
authors.initials: WR
authors.lastname: Mindak
authors.forename: Staci
authors.initials: S
authors.lastname: Mitvalsky
authors.forename: Karen E
authors.initials: KE
authors.lastname: Murphy
authors.forename: Agnes
authors.initials: A
authors.lastname: NguyenPho
authors.forename: Karen W
authors.initials: KW
authors.lastname: Phinney
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: Porter
authors.forename: Mark
authors.initials: M
authors.lastname: Roman
authors.forename: Lane C
authors.initials: LC
authors.lastname: Sander
authors.forename: Mary B
authors.initials: MB
authors.lastname: Satterfield
authors.forename: Christine
authors.initials: C
authors.lastname: Scriver
authors.forename: Ralph
authors.initials: R
authors.lastname: Sturgeon
authors.forename: Jeanice Brown
authors.initials: JB
authors.lastname: Thomas
authors.forename: Robert D
authors.initials: RD
authors.lastname: Vocke
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Wise
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Wood
authors.forename: Lu
authors.initials: L
authors.lastname: Yang
authors.forename: James H
authors.initials: JH
authors.lastname: Yen
authors.forename: George C
authors.initials: GC
authors.lastname: Ziobro
mesh_terms: D000470:Alkaloids / Q000032:analysis; D002104:Cadmium / Q000032:analysis; D002118:Calcium / Q000032:analysis; D002241:Carbohydrates / Q000032:analysis; D019587:Dietary Supplements / Q000032:analysis; D029789:Ephedra / Q000737:chemistry* / Q000528:radiation effects; D005227:Fatty Acids / Q000032:analysis; D006813:Humidity; D012015:Reference Standards; D015203:Reproducibility of Results; D014131:Trace Elements / Q000032:analysis; D014815:Vitamins / Q000032:analysis
chemical_list: D000470:Alkaloids; D002241:Carbohydrates; D005227:Fatty Acids; D014131:Trace Elements; D014815:Vitamins; D002104:Cadmium; D002118:Calcium