349 / 620
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 analyzed.
1
All analytes defined in the
applicability statement are
measured.
yes
1
0.16-20 mg/100g
from LOQ - 100000 mg/100g
Carnitine
0.01 mg/100g
Analyte 2
Analyte 3
Analyte 4
Analyte 5
Carnitine
≤ 0.16 mg/100g reconstituted final product.
0.04 mg/100 g reconstituted final product
Analyte 2
Analyte 3
Analyte 4
Analyte 5
Spike recovery (%)
2
Bias vs SRM
3
b
Units
Limit of quantification (LOQ)
Method Reference #
CARN-06
Method title:
Principle of the method:
Determination of Carnitine in Infant Formula. Adult/Pediatric Nutritional Formula, food and feed
Extraction w/ MeOH/H2O, hydrolysis followed by HPLC-MS/MS using labeled carnitine
Notes:
Overall Score
Intermediate Reproducibility
(RSDiR)
Recommendation of ERP
2 years after First Action Status
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
ADDITIONAL EVALUATION PARAMETERS
SMPR Requirement
Analytical Range.
1
AOAC SMPR: 2012.010
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
0
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
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.
SPIFAN ERP Checklist v 1.6
27.06.2013
Carn-06 MEF Form
FOR ERP USE ONLY
DO NOT DISTRIBUTE