Stakeholder Panel Meeting Book - September 6, 2014 - page 76

53
Limit of Detection (LOD)
54
The minimum concentration or mass of analyte that can be detected in a given matrix
55
with no greater than 5% false positive risk and 5% false negative risk.
56
57
Limit of Quantitation (LOQ)
58
The minimum concentration or mass of analyte in a given matrix that can be reported
59
as a quantitative result
60
61
Lutein
62
CAS Number: 127-40-2. A
containing a
hydroxylated
β
-ring
hydroxylated
63
at the 3 position
at
one end and an
ε
-
ring hydroxylated at the 3′ position
at the
64
opposite end one end and a hydroxylated
ε
-ring at the opposite end
. Figure 3.
65
66
Lycopene
67
CAS number:
A carotenoid
containing no rings at either endwith psi-psi
68
end groups
. Also known as:
ψ,ψ
-carotene. Figure 4.
69
70
Repeatability
71
Variation arising when all efforts are made to keep conditions constant by using
72
the same instrument and operator, and repeating during a short time period.
73
Expressed as the repeatability standard deviation (SD
r
); or % repeatability
74
relative standard deviation (%RSD
r
).
75
76
Reproducibility
77
The standard deviation or relative standard deviation calculated from among-
78
laboratory data. Expressed as the reproducibility relative standard deviation
79
(SD
R
); or % reproducibility relative standard deviation (% RSD
R
).
80
81
Target Measurement Uncertainty (TMU)
82
The maximum measurement uncertainty that will satisfy the intended use of a given
83
method.
3
84
85
4.
Method Performance Requirements:
86
Analytical range
1
1300*
Limit of Quantitation (LOQ)
1*
Recovery
90-110%
Repeatability (RSD
r
)
1-100
8%
>100-1300
5%
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
2
+ RSD
r
2
+ U
s
2,
where RSD
R
= the relative standard deviation of reproducibility; RSD
r
= the relative standard
deviation of repeatability; and U
s
= the uncertainty of the sample.
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