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Parameter
Method Performance
Please
report in units as stated in SMPR!
Weighting
factor for
parameter
Suitability Ranking (1‐
3‐5)
(select from drop‐
down list, 5 = best)
SPIFAN matrices
Applicable to all forms of infant, adult, and/or pediatric
formula (powders, ready‐to‐feed liquids, and liquid
concentrates).
Any combination of milk, soy, rice, whey, hydrolyzed
protein, starch, and amino acids, with and without intact
protein.
All SPIFAN matrices used, as well as in‐house
infant formula and adult nutritional and
pediatric formulas
1
All analytes defined in the
applicability statement are
measured.
all‐trans‐lutein, cis isomers of lutein, all‐trans‐beta‐
carotene, cis isomers of beta‐carotene
All forms of lutein and beta‐carotene are
measured.
1
Lutein
1‐1300 mcg/100 g as fed
0.8‐2250 mcg/100 g as fed
β‐carotene
1‐1300 mcg/100 g as fed
0.8‐2250 mcg/100 g as fed
Lutein
n/a
0.08 mcg/100 g
β‐carotene
n/a
0.08 mcg/100 g
Lutein
1 mcg/100 g
0.27 mcg/100 g
β‐carotene
1 mcg/100 g
0.27 mcg/100 g
Spike recovery (%)
90‐110%
92‐108%
2
Bias vs SRM
n/a
n/a
3
1‐100 mcg/100 g
8%
≤
5.8%
100‐1300 mcg/100 g
5%
≤1.7
%
1‐100 mcg/100 g
n/a
≤6.3
%
100‐1300 mcg/100 g
n/a
≤2.7%
2
3
1
AOAC SMPR: 2014.014
Limit of detection (LOD)
1
Evaluation of Method Performance vs. SMPR requirements.
Repeatability (RSDr)
Accuracy/Recovery
Intermediate Reproducibility
(RSDiR)
Limit of quantification (LOQ)
Method Reference #
Carot‐02
Method title:
Principle of the method:
Determination of Lutein and β‐Carotene in Infant Formula and Adult Nutritionals
Powder samples are reconstituted in water, and liquid sample is first spiked with an internal standard and saponified with potassium hydroxide.
S l
th t t d ith MTBE d THF f ll
d b h
Th
t t f
th li id li id t ti
d i d d it
SMPR Requirement
Analytical Range.
1
SPIFAN ERP Checklist v 1.6
27.06.2013
b
Units
Bias against established method
Analytical equipment
1
Adequate proof of performance via system suitability
No established method.
Analytical equipment (UV/Vis spec, UHPLC, horizontal shaker) is commonly available in most labs.
move to Final Action/repeal/remove/expand 2 year term
0
No unique proprietary equipment/accessories are required.
Method does not require any special safety precautions e.g. personal protection from highly toxic solvents.
Halogenated solvents are not used.
a
Concentrations apply to (1) "ready to feed liquids" "as‐is"; (2) reconstituted powders (25 g into 200 g water); and (3) liquid concentrates diluted 1:1 by weight.
Did Method Author Consider ERP’s Method Specific
Recommendations
(See web link to specific method
comments):
Decision by ERP
carotene and lycopene be included in the method. While alpha‐carotene is separated with this method, it
was not included in the determination because only one SPIFAN matrix contained the analyte. Lycopene is
also separated, but is excluded due to poor standard injection precision and poor standard stability.
Proprietary equipment
Feedback from Users of the Method since being awarded
First Action
Official Methods
Status
Reproducibility (RSDR)
System suitability solutions are used in the method, and chromatograms show good separation of lutein
and beta‐carotene isomers as well as resolution from zeaxanthin, alpha‐carotene, and lycopene.
ADDITIONAL EVALUATION PARAMETERS
Notes:
Overall Score
Recommendation of ERP
2 years after First Action Status
Laboratory safety
Other Considerations
CAROT-02 MEF FORM (AUGUST 2016)
FOR ERP USE ONLY
DO NOT DISTRIBUTE