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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.
1
Fluoride
4-800 μg/100g
5-200 μg/100g
Chloride
4-2400 mg/100g
5-500 mg/100g
Fluoride
Not provided
1.27μg/100g
Chloride
0.006mg/100g
Fluoride
Not provided
4.24μg/100g
Chloride
0.02mg/100g
Spike recovery (%) Fluoride ((5-25μg/100g): 80–120%; (26-200μg/100g):
90–110%)
93.9% (spiked level1), 91.9% (spiked level2)
2
Chloride (95–105%)
100% (spiked level1), 101% (spiked level2)
Bias vs SRM
SRM value not provided
SRM value not provided
3
Fluoride (5-25μg/100g) ≤ 8%; (26-200μg/100g) ≤5%
2.00%
Chloride
1%
Not provided
Fluoride (5-25μg/100g) ≤ 15%; (26-200μg/100g) ≤10%
5.40%
Chloride
2%
b
Units
Other Considerations
Limit of quantification (LOQ)
Method Reference #
2014.016
Method title:
Principle of the method:
Ion Chromatography method for the determination of Fluoride and Chloride in Infant Formula and Adult Nutritionals
Ion Chromatography with suppressed conductivity detection
SMPR Requirement
Analytical Range.
1
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
AOAC SMPR: 2014.016
Limit of detection (LOD)
1
Intermediate Reproducibility
(RSDiR)
a
Concentrations apply to (1) "ready to feed liquids" "as-is"; (2) reconstituted powders (2.50 g into 20 g water); and (3) liquid concentrates diluted (10g in 20g water).
Did Method Author Consider ERP’s Method Specific
Recommendations
(See web link to specific method
comments):
Decision by ERP
Proprietary equipment
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.
Notes:
Overall Score
Recommendation of ERP
2 years after First Action Status
Laboratory safety
3
1
2
Bias against established method
Analytical equipment
1
Adequate proof of performance via system suitability
Is there a bias Yes/No ? No certified value provided in SMPR
Analytical equipment is commonly available in most labs.
SPIFAN ERP Checklist v 1.6
27.06.2013
Fluor-02/Chlor-03 (February 2016) - MEF
FOR ERP USE ONLY
DO NOT DISTRIBUTE