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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.
1
All analytes defined in the
applicability statement are
measured.
Yes
1
0.5 ‐ 300 mcg/100g
0.3 ‐ 500 mcg/100g
Analyte 1
0.10 mcg/100g
0.09 mcg/100g
Analyte 2
Analyte 3
Analyte 4
Analyte 5
Analyte 1
0.5 mcg/100g
0.3 mcg/100g
Analyte 2
Analyte 3
Analyte 4
Analyte 5
Spike recovery (%) 90‐110
93‐104
2
Bias vs SRM SRM 1849 2.38 mcg/100g
2.42 mcg/100g
3
0.5 mcg/100g
11% or less RSD
2.7% (1.1 mcg/100g)
22‐85 mcg/100g
7% or less RSD
7 ‐ 12.7% (20‐66 mcg/100g)
0.5 mcg/100g
11% or less RSD
2.7% (1.1 mcg/100g)
22‐85 mcg/100g
7% or less RSD
7 ‐ 12.7% (20‐66 mcg/100g)
Blank Check sample and check standards at the lowest point
Blank Check sample and check standards at the
lowest point and midrange point of the analytical
b
Units
Analytical equipment
1
Adequate proof of performance via system suitability
Is there a bias Yes/No ?
Analytical equipment 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.
3
1
2
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
Bias against established method
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 #
Folate‐22 (OMA 2011.06)
AOAC SMPR: ………….. 2011.06
Analytical Range.
1
Method title:
Principle of the method:
Folate Analysis in Infant Formula and Adult Nutritional Samples
An UPLC‐MS/MS method for determining total folate after trienzyme digestion of the food matrix. Important folate vitamers are analyzed and sum of those as folic acid is
calculated.
SMPR Requirement
SPIFAN ERP Checklist v 1.6
27.06.2013
2011.06 (Fol-22) MEF Form
FOR ERP USE ONLY
DO NOT DISTRIBUTE