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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.
Applicable to all product types.
1
All analytes defined in the
applicability statement are
measured.
Chloride
Chloride is measured.
1
5-500 mg/100g*
minimum from 2.4 mg/100g
(Mehtod can be used in 99.9% salt content with
appropriate dilution factor)
Unknown
Not required
5 mg/100g*
2.4 mg/100g*
Spike recovery (%)
95 - 105 %
10 SPIFAN samples were spiked at 2 levels of
chloride on 3 separate days.
Spike level 1: Average recoveries of 101.6 %
(Recovery Range 99.7- 103.5%)
Spike level 2: Average recovery of 101.9 %
(Recovery Range 100.1 - 104.0 % ).
2
Bias vs SRM NIST 1849a informational value = 710 mg/100g
Value found = 709.5 mg/100g
No bias at 95% confidence level.
3
Average RSDr = 0.87% (10 products)
(RSDr Range 0.43 - 1.34 %; Range evaluated 38.2 -
162 mg/100g RTF)
See table 3 for values
Average RSDr = 1.76% (10 products)
(RSDr Range 0.80 - 3.04 %; Range evaluated 38.2 -
162 mg/100g RTF)
See table 3 for values
b
Units
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.
3
1
2
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
Laboratory safety
Other Considerations
Notes:
Overall Score
Recommendation of ERP
2 years after First Action Status
AOAC SMPR: 2014.015
Limit of detection (LOD)
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
Chloride
< 2 %
ADDITIONAL EVALUATION PARAMETERS
Intermediate Reproducibility
(RSDiR)
Chloride
< 4 %
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.
Limit of quantification (LOQ)
Method Reference #
Method title:
Principle of the method:
Chlorine in Infant Formula and Adult/Pediatric Nutritional Formula by Potentiometric Titration
Sample treats with potassium ferrocyanide and zinc acetate to precipitate protein, acidifies with nitric acid, and titrates using silver nitrate as
titrant. The endpoint of titration determines by the potentiometric method on a silver titrode with silver sulfide coating electrode. Calculate the
chlorine content in the sample via the titrant volume of endpoint.
SMPR Requirement
Analytical Range.
1
Chloride
Chloride
SPIFAN ERP Checklist v 1.6
27.06.2013
Chlor-04 MEF Form
FOR ERP USE ONLY
DO NOT DISTRIBUTE