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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
5
All analytes defined in the
applicability statement are
measured.
Chloride
Chloride is measured.
1
5
Spike recovery (%)
95 - 105 %
SPIFAN samples (15) were spiked at 2 levels of
chloride on 3 separate days.
Spike level 1: Average recoveries of 100.1 %
(Recovery Range 101- 103%)
Spike level 2: Average recovery of 100.0 %
(Recovery Range 99 - 103 % ).
2
5
Bias vs SRM NIST 1849a informational value = 710 mg/100g
Value found = 685 mg/100g , 97.2 % recovery.
No bias at 95% confidence level.
See Table 2
3
5
Average RSDr = 0.31% (17 products)
(RSDr Range 0.03 - 1.60 %; Range evaluated 20 -
167 mg/100g RTF)
See table 3 for values
Average RSDr = 0.54% (17 products)
(RSDr Range 0.09 - 2.77 %; Range evaluated 20 -
167 mg/100g RTF)
5
5
5
b
Units
Chloride
< 2 %
< 4 %
Chloride
Limit of quantification (LOQ)
Method Reference #
LI-08.580
Method title:
Principle of the method:
Chloride by Potentiometry
A quantitative method for the determination of the chloride and sodium chloride contents by potentiometric
titration using silver nitrate.
1.4-1060 mg/100g
Notes:
Overall Score
Intermediate Reproducibility
(RSDiR)
5
Recommendation of ERP
2 years after First Action Status
Chloride
Unknown
Not required
5-500 mg/100g*
Chloride
5 mg/100g*
1.4 mg/100g*
See table 3 for values
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
5
5
ADDITIONAL EVALUATION PARAMETERS
SMPR Requirement
Analytical Range.
1
AOAC SMPR: 2014.015
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
Laboratory safety
Other Considerations
move to Final Action/repeal/remove/expand 2 year term
85
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
5
Bias against established method
Analytical equipment
1
Adequate proof of performance via system suitability
Analytical equipment is commonly available in most labs.
SPIFAN ERP Checklist v 1.6
27.06.2013
Chlor-02 MEF Form
FOR ERP USE ONLY
DO NOT DISTRIBUTE