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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 SPIFAN matrices evaluated met precision and
accuracy requirements for all four vitamins.
Precision = 14 matrixes evaluated
Accuracy = 8 unique matrixes evaluated.
All analytes defined in the
applicability statement are
measured.
Total B1, B2, B3, and B6
Method determines these four vitamins simultaneously
from the same injection
all units ug/100g of RTF
Total B1
20 - 2000
same
Total B2
30 - 4000
same
Total B3
200 - 10000
same
Total B6
10 - 2000
nearly same
Total B1
≤ 20
9.79
Total B2
≤ 30
8.65
Total B3
≤ 200
95.2
Total B6
≤ 10
12.75
Total B1
92.4 - 102.5, mean 97.1% recovery
Total B2
95.1 - 100.7, mean 97.9% recovery
Total B3
100.3 -
110.7
, mean 103.8% recovery
Total B6
96.8 - 100.5, mean 99.1% recovery
Total B1
2.2% higher than certified
Total B2
11.5% higher than certified
Total B3
4.7% lower than certified
Total B6
1.7% higher than certified
Total B1
≤ 5%
1.1
Total B2
≤ 5%
2.3
Total B3
≤ 5%
1.2
Total B6
≤ 5%
1.5
Total B1
not stated
3.4
Total B2
not stated
5.1
Total B3
not stated
2.8
Total B6
not stated
4.4
Total B1
≤ 10%
not tested yet
Total B2
≤ 10%
not tested yet
Total B3
≤ 10%
not tested yet
Total B6
≤ 10%
not tested yet
b
Units
Bias against established method
Analytical equipment
Adequate proof of performance via system suitability
Is there a bias Yes/No ?
Analytical equipment is commonly available in most labs.
No unique proprietary equipment/accessories are required.
Method does not require any special safety precautions e.g. personal protection from highly toxic solvents.
Samples are enzymatically digested with a stable isotope labeled internal standard and analyzed by LC-MS/MS.
Limit of quantification (LOQ)
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
Intermediate Reproducibility
(RSDiR)
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: 2015.002, 2015.003, 2015.004, and 2015.005
Method Reference #
BVIT-02
Method title:
Principle of the method:
Simultaneous Determination of Total Vitamin B6, B2, B3 and B1 in Infant Formula Products by LC-
MS/MS using Enzyme Digestion
Analytical Range.
Notes:
Overall Score
Recommendation of ERP
2 years after First Action Status
90-110 % mean spiked recovery over the Range
Spike recovery (%)
Bias vs SRM
Use SRM 1849a
Repeatability (RSDr)
SPIFAN ERP Checklist v 1.6
27.06.2013
BVit-02 - MEF FORM
FOR ERP USE ONLY
DO NOT DISTRIBUTE