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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
2
•
Well laid out method with good detail.
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ISTD added at beginning of sample preparation
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Method contains specific information on testing different levels of carotenoids, infant formula vs foods
with high carotenoid concentrations.
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Both UV Spectrophotometric and Chromatographic purity performed.
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Resolution solutions for Cis and trans lutein, carotene isomers etc. to determine the resolution
between the applicable isomers, zeaxanthin and ISTD.
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5 point curve has been added
Method performance requirements:
Applicability: Determinations of all-trans α-carotene cis isomers of α-carotene, all-trans β-carotene), cis
isomers of β-carotene, all-trans lutein, cis isomers of lutein, and lycopene in all forms of infant, adult,
and/or pediatric formula (powders, ready-to-feed liquids, and liquid concentrates).
Analytical range
1–1300 mcg/100g RTF
Limit of quantitation (LOQ)
≤1 mcg/100g RTF
Recovery
90–110%
Repeatability (RSDr)
1–100
8%
>100–1300
5%
Reproducibility (RSDR)
1–100
15%
>100–1300
10%
Analytical Range:
Lutein & Beta Carotene – 0.8-2250mcg/100g RTF
Linearity:
R2 is 1.0 for lutein, beta carotene and ISTD
LOQ:
0.27 μg/100 g RTF for lutein and β-carotene.
Accuracy/Recovery:
92 -108%
Precision (RSD
r
):
1-100 mcg/100g RTF - < 5.8%
100-1300 mcg/100g RTF - < 1.7%
Intermediated Precision:
1-100 mcg/100g RTF - 6.3%
100-1300 mcg/100g RTF - < 2.7%
System suitability:
System suitability solutions are prepared and used for peak resolution - suggest theses are also for
reference standard repeatability or use the mid calibration standard.
Slope accuracy is included in the method and is set at < 2.0%
Recommendation:
Recommend for First Action and MLT Study