38 / 41
FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
1
Expert Review Panel for Infant Formula and Adult Nutrition
Evaluation of Method
2014.02
Title:
AOAC Official Method 2014.02, Vitamin B12 in Infant Formula and Adult/Pediatric Formulas Ultra-High-
Performance Liquid Chromatography / First Action 2014
Author:
Nestlé Research Center; E. Campos Giménez
General comments about the method:
Consideration for Final Action Status
•
Performance Characteristics
-
Does the method meet the SMPR for the following:
Reproducibility (RSD
R
):
An MLT study was performed to characterize method precision, including reproducibility. Ten
samples were studied, 7 powders and 3 liquids. SRM 1849A was included as part of the sample set.
18 laboratories provided final results in time for reporting. Most of the data sets had 1 or 2 outliers
removed, while 2 of the data sets had 3 outliers removed. One last data set had 5 sets of results
not considered, 2 as outliers and 3 of which because the method was not followed correctly.
The results produced by individual laboratories for the blind sample pairs were consistent: all 10
samples met the RSD
r
criterion of ≤ 5%.
The results produced for the same samples across the different laboratories also generally showed
good agreement, with 9 of the 10 samples meeting the RSD
R
criterion of ≤ 11%; a single sample
produced a value of 23%.
In general, the RSD
R
results observed in the MLT for this method were lower than were observed in
the MLT for AOAC 2011.10, which was approved as Final Action in September 2014, on the basis of
an MLT in which 7 of 12 samples met the RSD
R
criterion of ≤ 11%.
Overall, the validation results for both methods were very similar, and method 2014.02 appears to
work at least as well as the current Final Action 2011.10
Recommendation:
I would recommend this method for approval as a Final Action.