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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.
yes
1
All analytes defined in the
applicability statement are
measured.
yes
1
0.03-5% (as-fed)
45-100% (ingredient commodity)
Analyte 1
NA
Analyte 2
Analyte 3
Analyte 4
Analyte 5
Analyte 1
≤
0.03
≤
0.03% (as-fed)
Analyte 2
Analyte 3
Analyte 4
Analyte 5
Spike recovery (%)
90-110%
92.9-108%
2
Bias vs SRM
NA
NA
3
≤6%
1.09-3.67
2.46-6.79
≤12%
≤12%
≤12%
≤12%
≤12%
b
Units
Analytical Range.
1
Method title:
Principle of the method:
Determination of Fructans in Infant and Adult/Pediatric Nutritional Formula as well as ingredient commodities
Qualitative ID of fructan present in material and then quantitative analysis of fructan content (both using HPAEC-PAD instrumentation).
SMPR Requirement
Evaluation of Method Performance vs. SMPR requirements.
Feedback from Users of the Method since being awarded
First Action
Official Methods
Status
Repeatability (RSDr)
Reproducibility (RSDR)
Accuracy/Recovery
ADDITIONAL EVALUATION PARAMETERS
Intermediate Reproducibility
(RSDiR)
Limit of quantification (LOQ)
Method Reference #
FOS-04
AOAC SMPR: …2014.002………..
Limit of detection (LOD)
1
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
Proprietary equipment
Notes:
Overall Score
Recommendation of ERP
2 years after First Action Status
Laboratory safety
Other Considerations
3
1
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.
2
Bias against established method
Analytical equipment
1
Adequate proof of performance via system suitability
Is there a bias Yes/No ?
Analytical equipment is commonly available in most labs.
SPIFAN ERP Checklist v 1.6
27.06.2013
Fos-04 -MEF (February 2016)
FOR ERP USE ONLY
DO NOT DISTRIBUTE