Stakeholder Panel Meeting Book - September 6, 2014

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Limit of Detection (LOD)

The minimum concentration or mass of analyte that can be detected in a given matrix with no greater than 5% false positive risk and 5% false negative risk.

Limit of Quantitation (LOQ)

The minimum concentration or mass of analyte in a given matrix that can be reported

as a quantitative result

Lutein

CAS Number: 127-40-2. A carotenoid containing a hydroxylated β -ring hydroxylated at the 3 position at one end and an ε - ring hydroxylated at the 3′ position at the opposite end one end and a hydroxylated ε -ring at the opposite end . Figure 3.

Lycopene

CAS number: 502-65-8. A carotenoid containing no rings at either endwith psi-psi

end groups . Also known as: ψ,ψ -carotene. Figure 4.

Repeatability

Variation arising when all efforts are made to keep conditions constant by using the same instrument and operator, and repeating during a short time period. Expressed as the 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 ).

Target Measurement Uncertainty (TMU)

The maximum measurement uncertainty that will satisfy the intended use of a given

method. 3

4. Method Performance Requirements:

Analytical range

1 – 1300*

Limit of Quantitation (LOQ)

≤ 1*

Recovery

90-110%

Repeatability (RSD r ) 1-100

8% 5%

>100-1300

Reproducibility (RSD R ) 1-100

15%

>100-1300 10% 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.

3 See VIM definition 2.34 for a formal definition. Calculated as: TMU = √ RSD R = the relative standard deviation of reproducibility; RSD r where RSD R

2 + RSD r

2 + U s

2,

= the relative standard

deviation of repeatability; and U s

= the uncertainty of the sample.