AOAC SMPR 2012.010 Table 1.
Method performance requirementsa
Analytical range 0.16–20b
Limit of quantitation (LOQ) ≤0.16b
Standard Method Performance Requirements for
L-Carnitine in Infant Formula and Adult/Pediatric Repeatability (RSDr) 0.16–20b ≤8%
Nutritional Formula Recovery 90 to 110% of mean spiked
recovery over the range of the
assay
Intended Use: Global dispute resolution method Reproducibility (RSDR) 0.16–20b ≤15%
a
Concentrations apply to: (1) “ready-to-feed” liquids “as is”;
1 Applicability (2) reconstituted powders (25 g into 200 g water); and (3) liquid
concentrates diluted 1:1 by weight.
Determination of supplemented and endogenous L-carnitine b
mg/100 g reconstituted final product.
[3-hydroxy-4-(trimethylazaniumyl) butanoate; CAS No.
541-15-1] in all forms of infant, adult, and/or pediatric formula
(powders, ready-to-feed liquids, and liquid concentrates). Methods .—The standard deviation or relative standard
must be able to determine free and total carnitine; report as deviation calculated from among-laboratory data. Expressed as
L-carnitine. the reproducibility standard deviation (SDR); or % reproducibility
2 Analytical Technique relative standard deviation (%RSDR).
Recovery.—The fraction or percentage of spiked analyte that is
Any analytical technique that meets the following method recovered when the test sample is analyzed using the entire method.
performance requirements is acceptable.
4 Method Performance Requirements
3 Definitions
See Table 1.
Adult/pediatric formula.—Nutritionally complete, specially
5 System Suitability Tests and/or Analytical Quality Control
formulated food, consumed in liquid form, which may constitute
the sole source of nourishment [AOAC Stakeholder Panel on Infant Suitable methods will include blank check samples, and check
Formula and Adult Nutritionals (SPIFAN); 2010], made from any standards at the lowest point and midrange point of the analytical
combination of milk, soy, rice, whey, hydrolyzed protein, starch, range.
and amino acids, with and without intact protein. 6 Reference Material(s)
Infant formula.—Breast-milk substitute specially manufactured
NIST Standard Reference Material® (SRM) 1849a Infant/
to satisfy, by itself, the nutritional requirements of infants during
Adult Nutritional Formula, or equivalent. The SRM is a milk-
the first months of life up to the introduction of appropriate
based, hybrid infant/adult nutritional powder prepared by a
complementary feeding (Codex Standard 72–1981), made from
manufacturer of infant formula and adult nutritional products.
any combination of milk, soy, rice, whey, hydrolyzed protein, A unit of SRM 1849a consists of 10 packets, each containing
starch, and amino acids, with and without intact protein. approximately 10 g material. Certified value of NIST 1849a is
Limit of detection (LOD).—The minimum concentration or mass 136 mg/kg L-carnitine.
of analyte that can be detected in a given matrix with no greater
7 Validation Guidance
than 5% false-positive risk and 5% false-negative risk.
Limit of quantitation (LOQ).—The minimum concentration Recommended level of validation: Official Methods of
or mass of analyte in a given matrix that can be reported as a AnalysisSM.
quantitative result. 8 Maximum Time-to-Result
Repeatability.—Variation arising when all efforts are made
Less than 24 h.
to keep conditions constant by using the same instrument and
operator, and repeating during a short time period. Expressed as the Approved by the AOAC Stakeholder Panel on Infant Formula and
repeatability standard deviation (SDr); or % repeatability relative Adult Nutritionals (SPIFAN) on September 29, 2012. Final Version
standard deviation (%RSDr). Date: September 29, 2012.
© 2012 AOAC INTERNATIONAL
