Stakeholder Panel Meeting Book - September 6, 2014
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repeatability standard deviation (SD r
); or % repeatability relative standard deviation
(%RSD r
).
Reproducibility
The standard deviation or relative standard deviation calculated from among-laboratory
data. Expressed as the reproducibility relative standard deviation (SD R
); or % reproducibility
relative standard deviation (% RSD R ).
Vitamin B 2
(riboflavin)
An isoalloxazine ring ( flavin ring) substituted at the 10 position with a D-ribityl side chain. Flavin mononucleotide (FMN) consists of a flavin ring phosphoryled at the 5’ position of the ribityl side chain. CAS number: 146-17-8. Flavin adenine dinucleotide (FAD) consists of an FMN unit with an additional adenosine-5’-monophosphate. CAS number: 146-14-5. FAD
is the principle form of B 2
in biological material.
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Figure 1: Chemical structure of riboflavin
4. Method Performance Requirements:
Analytical range
40 – 350*
Limit of Quantitation (LOQ)
≤ 40*
Accuracy
± 40%
Repeatability (RSD r )
≤ 14%
Reproducibility (RSD R )
≤ 20%
Concentrations apply to: a) ‘ready-to-feed” liquids “as is”; b) re- constituted powders (25 g into 200 g of water); and c) liquid concentrates diluted 1:1 by weight.
69 70
*μg /100 g reconstituted final product.
2
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