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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 materials tested in the SLV kit. Please see the SLV report for all data regarding this summary. Intermediate precision has been calculated since the time of the report, so the intermediate precision tables are inc
1
All analytes defined in the
applicability statement are
measured.
Total Choline and Free and Total L-Carnitine
tal choline and fre and total carnitine are measured, but the SMPR does not include free choline analysis in the applicability so that data is not included in this summary table. Although, the SLV report and tables provided include all data for free choline. The
1
Total Choline
2-250 mg/100g
Method measures across required ranges.
Free and Total Carnitine
0.16-20 mg/100g
Total Choline
0.7 mg/100g
0.0047 mg/100g
Free and Total Carnitine
NA
0.0034 mg/100g
Total Choline
2 mg/100g
0.05 mg/100g
Free and Total Carnitine
≤
0.16 mg/100g
0.05 mg/100g
Spike recovery (%)
Total Choline and free and total L-Carnitine 90 to 110% of
mean spiked recovery over the range of the assay.
Global %recovery 98.2-101.2 "total", 95.5-102.6
"marginal" across the 50 and 100% overspikes for
all free and total choline and carnitine. LOQ level
2
Bias vs SRM SRM provides total choline, free choline, and free carnitine
Ave age results are a l within the certified ranges
and 1.9% RPD from the information mass fraction
value for free choline
3
Total Choline
2 mg/100g, ≤ 10%
Total choline 2.3%RSDr
20 - 200 mg/100g, ≤ 5%
Free and Total Carnitine
0.16 - 20 mg/100g, ≤ 8%
Free carnitine 2.9%RSDr, and total carnitine 2.7%RSDr
Total Choline
NA
Total choline 2.7%RSDiR
Free and Total Carnitine
NA
Free carnitine 3.3%RSDiR, and total carnitine 3.1%RSDiR
Total Choline
NA
Free and Total Carnitine
NA
b
Units
No unique proprietary equipment/accessories are required.
Method does not require any special safety precautions e.g. personal protection from highly toxic solvents.
Limit of quantification (LOQ)
Method Reference #
CRN-07
Method title:
Principle of the method:
Determination of Free and Total Choline and Carnitine in Infant Formula and Adult/Pediatric Nutritional Formula
Free choline and carnitine are extracted in water and analyzed by LC/MS/MS, while total choline and carnitine are extracted by aci
SMPR Requirement
Analytical Range.
1
AOAC SMPR: 2012.010 and 2012.013
Limit of detection (LOD)
1
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
Intermediate Reproducibility
(RSDiR)
Refer to SLV report
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
Notes:
Overall Score
Recommendation of ERP
2 years after First Action Status
move to Final Action/repeal/remove/expand 2 year term
0
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-07 MEF Form
FOR ERP USE ONLY
DO NOT DISTRIBUTE