AOAC SMPR 2017.XXX; Version 3; February 9, 2017
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Method Name: Determination of Lutein in Infant and Adult/ Pediatric
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Nutritional Formula
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Approved by:
Stakeholder Panel for
Infant Formula and Adult Nutritionals
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Final version date
:
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Effective date:
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Intended Use:
Reference method for dispute resolution.
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1.
Applicability:
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Determinations of
all-
trans
lutein (CAS 127-40-2) and
cis
isomers of lutein
in all
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forms of infant, adult, and/or pediatric formula (powders, ready-to-feed liquids, and
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liquid concentrates).
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2.
Analytical Technique:
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Any analytical technique that meets the following method performance
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requirements is acceptable.
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3.
Definitions:
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Accuracy
(Corresponds to the VIM definition for “trueness”).
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The closeness of agreement between the average of an infinite number of replicate
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measured quantity values and a reference quantity value.
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Adult/Pediatric Formula
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Nutritionally complete, specially formulated food, consumed in liquid form, which may
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constitute the sole source of nourishment [AOAC Stakeholder Panel on Infant
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Formula and Adult Nutritionals (SPIFAN); 2010], made from any combination of milk,
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soy, rice, whey, hydrolyzed protein, starch, and amino acids, with and without intact
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protein.
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Infant formula
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Breast-milk substitute specially manufactured to satisfy, by itself, the nutritional
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requirements of infants during the first months of life up to the introduction of
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appropriate complementary feeding (Codex Standard 72 – 1981), made from any
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combination of milk, soy, rice, whey, hydrolyzed protein, starch, and amino acids,
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with and without intact protein.
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Limit of Detection (LOD)
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The minimum concentration or mass of analyte that can be detected in a given matrix
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with no greater than 5% false positive risk and 5% false negative risk.
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Limit of Quantitation (LOQ)
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The minimum concentration or mass of analyte in a given matrix that can be reported
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as a quantitative result
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Lutein
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All-
trans
lutein (IUPAC name: (1R)-4-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-18-
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[(1R,4R)-4-hydroxy-2,6,6-trimethylcyclohex-2-en-1-yl]-3,7,12,16-
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tetramethyloctadeca-1,3,5,7,9,11,13,15,17-nonaenyl]-3,5,5-trimethylcyclohex-3-en-1-
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ol, (CAS number: 127-40-2) and its
cis
isomers. Figure 1.
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