625 / 696
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.
1
5
All analytes defined in the
applicability statement are
measured.
1
5
0.12-5.1
0.05-10
Vitamin D
2
≤0.02
0.0003
Vitamin D3
≤0.02
0.00038
Analyte 3
Analyte 4
Analyte 5
Vitamin D2 and D3 ≤0.12
0.00081
Vitamin D3
≤0.12
0.00096
Analyte 3
Analyte 4
Analyte 5
Spike recovery (%)
97
2
5
Bias vs SRM
4%
3
5
0.12
≤15%
vitamin D2 3.5%
1.5
≤1
1
%
vitamin D3 3%;vitamin D2 5.2%
2.5
≤1
1
%
vitamin D2 4.1%
5.1
≤1
1
%
1
1
1
1
5
5
5
1
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.
2
5
5
move to Final Action/repeal/remove/expand 2 year term
92
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
AOAC SMPR: AOAC SMPR 2011.004
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
Proprietary equipment
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
1
5
ADDITIONAL EVALUATION PARAMETERS
Notes:
Overall Score
Intermediate Reproducibility
(RSDiR)
1
Recommendation of ERP
2 years after First Action Status
Laboratory safety
Other Considerations
Limit of quantification (LOQ)
Method Reference #
Method title:
Principle of the method:
Determination Method for Vitamin D derivatized with 4-phenyl-1,2,4-triazoline-3,5-dione(PTAD) in Milk Powder by UHPLC-MS/MS
Test sa ples are saponified, extracted, and the solvent evaporated. Vitamin D is derivatized with 4-phenyl-1,2,4-triazoline-3,5-dione, and then determined by UHP
SMPR Requirement
Analytical Range.
1
SPIFAN ERP Checklist v 1.6
27.06.2013
VitD-17 MEF (February 2016)
FOR ERP USE ONLY
DO NOT DISTRIBUTE