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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 forms of infant, andult and/or
pediatric formula. Any combination of milk, whey
hydrolyzed protein, starch and amino acids, with
and without intact protein.
1
5
All analytes defined in the
applicability statement are
measured.
Calcium, copper, iron magnesium, manganes, phosphorus,
potassium, sodium and zinc contents.
Calcium, copper, iron magnesium, manganes,
phosphorus, potassium, sodium and zinc contents.
1
5
Different analytical range per analyte!
Different analytical range per analyte!
0.001 (lower analytical range Mn) - 2000 (upper analytical
range K)
0.003 (lower analytical range Mn) - 1875 (upper
analytical range K)
* reconstituted final product
* reconstituted final product
Ca
0.1
Cu
0.002
Fe
0.09
K
2.6
Mg
0.03
Mn
0.001
Na
0.2
P
0.01
Zn
0.004
Ca
20
0.4
Cu
0.023
0.01
Fe
0.1
0.2
K
10
6
Mg
3
0.09
Mn
0.001
0.003
Na
10
0.5
P
15
0.04
Zn
0.4
0.01
Spike recovery (%)
90-110%
All recoveries are between 90.5% and 108.8%
2
5
Bias vs SRM
No requirement in SMPR
No Bias. See table 2 for all elements.
3
5
Ca
5%
0.82
Cu
5%
0.31
Fe
5%
0.70
K
5%
0.51
Mg
5%
0.85
Mn
5% - 8%
0.68
Na
5%
0.42
P
5%
0.65
Zn
5%
1.02
Ca
Cu
Fe
K
Mg
Mn
Na
P
Zn
Ca
8%
1.2
Cu
10%
1.7
Fe
10%
0.9
K
8%
1.4
Mg
10%
1.2
Mn
10% - 16%
1.4
Na
8%
1.2
P
8%
1
Zn
10%
1
5
5
5
5
5
5
5
5
b
Units
SMPR Requirement
Analytical Range.
1
Method Reference #
MTE3 (ISO/CD 15151 | IDF 229)
Method title:
Principle of the method:
Milk and milk products - Determination of calcium, copper, iron, magnesium, manganese, phosphorus, potassium, sodium and zinc contents - Indu
Determination of minerals total calcium, magnesium, phosphorus potassium and/or sodium and trace elements copper, iron, manganese and/or zinc in all forms of infa
Notes:
Overall Score
Not applicable
Intermediate Reproducibility
(RSDiR)
5
Recommendation of ERP
2 years after First Action Status
Laboratory safety
Other Considerations
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
System is suitable
5
ADDITIONAL EVALUATION PARAMETERS
AOAC SMPR: 2014.004
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
Yes. Improvements are made based on the ERP comments in March 2015.
Proprietary equipment
move to Final Action/repeal/remove/expand 2 year term
120
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
5
No LOD requirement in SMPR
No requirement in SMPR
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.
Limit of quantification (LOQ)
SPIFAN ERP Checklist v 1.6
27.06.2013