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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.
All 11 SPIFAN matrices met precision and accuracy
requirements for all nine minerals (plus Cr, Mo, Se)
1
All analytes defined in the
applicability statement are
measured.
Ca, Cu, Fe, Mg, Mn, P, K, Na, Zn
Method determines these nine elements as well as Cr,
Mo, Se simultaneously from same digest.
1
all units mg/100g of RTF
Ca
20 - 1280
same
Cu
0.001 - 1.2
need to verify low end
Fe
0.01 - 20
need to verify low end
Mg
3 - 110
same
Mn
0.001 - 1.0
need to verify low end
P
15 - 800
same
K
10 - 2000
same
Na
10 - 850
same
Zn
0.1 - 18
same
Cr
20-1600 ng/g
same
Mo
20-1000 ng/g
same
Se
10-500 ng/g
same
Ca
20
2.5
Cu
0.001
0.0125
Fe
0.01
0.125
Mg
3.0
0.50
Mn
0.001
0.0125
P
15
1.3
K
10
2.5
Na
10
1.3
Zn
0.1
0.05
Cr
20 ng/g RTF
20
Mo
20 ng/g RTF
20
Se
10 ng/g RTF
10
Ca
90-104, mean 99.6% recovery
Cu
90-106, mean 97.6% recovery
Fe
93-101, mean 97.9% recovery
Mg
93-104, mean 100.5% recovery
Mn
93-101, mean 97.9% recovery
P
98-109, mean 102.9% recovery
K
92-110, mean 103.0% recovery
Na
100-106, mean 103.4% recovery
Zn
93-99, mean 97.4% recovery
Cr
98-102, mean 100% recovery (above PLOQ)
Mo
93-108, mean 95.7% recovery
Se
99-106, mean 102.8% recovery
Ca
1.7% higher than certified
Cu
2.4% lower than certified
Fe
0.9% lower than certified
Mg
1.3% lower than certified
Mn
1.4% lower than certified
P
7.7% higher than certified
K
0.7% higher than certified
Na
0.6% higher than certified
Zn
2.0% higher than certified
Cr
2.3% lower than certified
Mo
3.8% lower than certified
Se
0.6% higher than certified
Cu, Fe, Zn, Mg
5%
method requires duplicate checks <5%
P, Na, Ca, K
5%
method requires duplicate checks <5%
Mn >0.005
5%
method requires duplicate checks <5%
Mn <0.005
8%
method requires duplicate checks <5%
Cr, Mo Se
5%
method requires duplicate checks <5%
Cu, Fe, Zn, Mg
not stated
Cu=1.7-4.9%;Fe=1.9-4.3%;Zn=1.5-2.6%;Mg=1.8-3.4%
P, Na, Ca, K
not stated
P=1.7-5.0%;Na=1.8-3.2%;Ca=1.8-3.5%;K=1.1-3.9%
Mn >0.005
not stated
Mn- 1.3-4.8%
Mn <0.005
not stated
not tested
Cr, Mo, Se
not stated
Cr=1.3-6.3%; Mo=2.6-5.1%; Se = 2.7-6.5%
Cu, Fe, Zn, Mg
10%
Cu=2.3-8.4%;Fe=3.5-5.5%;Zn=2.3-9.7%;Mg=6.2-16.1%
P, Na, Ca, K
8%
P=4.8-
9.7
%; Na=6.5-7.7%;Ca=4.7-6.5%;K=4.5-6.2%
Mn >0.005
10%
Mn = 3.2-5.7%
Mn <0.005
16%
not tested
Cr, Mo, Se
15%
Cr = 4.7-13.0%; Mo = 3.0-7.9%; Se = 2.5-7.3%
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.
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
0
No unique proprietary equipment/accessories are required.
Method does not require any special safety precautions e.g. personal protection from highly toxic solvents.
Evaluation of Method Performance vs. SMPR requirements.
Feedback from Users of the Method since being
awarded First Action
Official Methods
Status
Reproducibility (RSDR)
ADDITIONAL EVALUATION PARAMETERS
SMPR Requirement
AOAC SMPR: 2014.004 (with 2011.009)
Method Reference #
MTE-02 (with additions from Chrom-06)
Method title:
Principle of the method:
Ca, Cu, Fe, Mg, Mn, P, K, Na, Zn by ICP-MS (this method also does Cr, Mo, Se)
Samples are MW digested with an internal standard and analyzed by ICP-MS via external calibration
2
Limit of quantification (LOQ)
Notes:
Overall Score
Recommendation of ERP
2 years after First Action Status
90-110 % mean spiked recovery over the Range
(all elements)
Spike recovery (%)
Bias vs SRM
Use SRM 1849a
2
3
Repeatability (RSDr)
3
Intermediate Reproducibility
(RSDiR)
1
Analytical Range.
1
SPIFAN ERP Checklist v 1.6
27.06.2013
MTE-02 MEF Form
FOR ERP USE ONLY
DO NOT DISTRIBUTE