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 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.
Sharpless
Katherine E
KE
National Institute of Standards and Technology, Analytical Chemistry Division, Gaithersburg, MD 20899-8390, USA. katherine.sharpless@nist.gov
Anderson
David L
DL
Betz
Joseph M
JM
Butler
Therese A
TA
Capar
Stephen G
SG
Cheng
John
J
Fraser
Catharine A
CA
Gardner
Graeme
G
Gay
Martha L
ML
Howell
Daniel W
DW
Ihara
Toshihide
T
Khan
Mansoor A
MA
Lam
Joseph W
JW
Long
Stephen E
SE
McCooeye
Margaret
M
Mackey
Elizabeth A
EA
Mindak
William R
WR
Mitvalsky
Staci
S
Murphy
Karen E
KE
NguyenPho
Agnes
A
Phinney
Karen W
KW
Porter
Barbara J
BJ
Roman
Mark
M
Sander
Lane C
LC
Satterfield
Mary B
MB
Scriver
Christine
C
Sturgeon
Ralph
R
Thomas
Jeanice Brown
JB
Vocke
Robert D
RD
Wise
Stephen A
SA
Wood
Laura J
LJ
Yang
Lu
L
Yen
James H
JH
Ziobro
George C
GC
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
D000470:Alkaloids; D002241:Carbohydrates; D005227:Fatty Acids; D014131:Trace Elements; D014815:Vitamins; D002104:Cadmium; D002118:Calcium