title: Sampling and analytical variability associated with the determination of total aflatoxins and ochratoxin A in powdered ginger sold as a dietary supplement in capsules.
abstract: The U.S. Food and Drug Administration is studying the need to monitor dietary supplements for mycotoxins such as total aflatoxins and ochratoxin A. An effective mycotoxin-monitoring program requires knowledge of the sampling and analytical variability associated with the determination of total aflatoxins (AF) and ochratoxin A (OTA) in dietary supplements. Three lots of ginger sold as a powder in capsule form and packaged in individual bottles were analyzed for both AF and OTA. The total variability associated with measuring AF and OTA in powdered ginger was partitioned into bottle-to-bottle, within bottle, and analytical variances. The variances were estimated using a nested design. For AF and OTA, the within-bottle variance associated with the 5 g laboratory sample size was the largest component of variability accounting for about 43% and 85% of the total variance, respectively; the analytical variance accounted for about 34% and 9% of the total variability, respectively; and the bottle-to-bottle variance accounted for about 23% and 7% of the total variance, respectively. When the total variance is converted into the coefficient of variation (CV or standard deviation relative to the mean concentration), the CV is lower for AF (16.9%) than OTA (24.7%).
authors.affiliation: U.S. Food and Drug Administration, College Park, Maryland, USA.
authors.forename: Mary W
authors.initials: MW
authors.lastname: Trucksess
authors.forename: Thomas B
authors.initials: TB
authors.lastname: Whitaker
authors.forename: Carol M
authors.initials: CM
authors.lastname: Weaver
authors.forename: Andrew
authors.initials: A
authors.lastname: Slate
authors.forename: Francis G
authors.initials: FG
authors.lastname: Giesbrecht
authors.forename: Jeanne I
authors.initials: JI
authors.lastname: Rader
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Betz
mesh_terms: D000348:Aflatoxins / Q000032:analysis*; D000704:Analysis of Variance; D002214:Capsules / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid / Q000379:methods / Q000592:standards* / Q000706:statistics & numerical data; D003257:Consumer Product Safety; D019587:Dietary Supplements / Q000032:analysis*; D020939:Zingiber officinale / Q000737:chemistry*; D009793:Ochratoxins / Q000032:analysis*
chemical_list: D000348:Aflatoxins; D002214:Capsules; D009793:Ochratoxins; C025589:ochratoxin A