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.

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*μg /100 g reconstituted final product.

2