APPENDIX 1: AOAC SMPR 2011.006: JOURNAL OF AOAC INTERNATIONAL VOL. 95, NO.
2, 2012 1
INFANT FORMULA AND ADULT NUTRITIONALS
AOAC SMPR 2011.006 4 Method Performance Requirementsa
Analytical range 0.50–300b
Standard Method Performance Requirements
Limit of detection (LOD) ≤0.10b
for Folate in Infant Formula and Adult/Pediatric
Nutritional Formula Limit of quantitation (LOQ) ≤0.50b
Repeatability (RSDr) 0.50b ≤11%
b
Intended Use: Global Dispute Resolution Method 21.5 ≤7%
b
43.0
1 Applicability 64.0b
85.0b
Determination of total folate [supplemental folic acid
(CAS 59-30-3) or 5-methyl-tetrahydrofolate (CAS 68792-52-9), Recovery 0.5 90–110%
b
and endogenous 5-methyl-tetrahydrofolate polyglutamate] in all 21.5
forms (powders, ready-to-feed liquids, and liquid concentrates) 43.0b
of infant, adult, and pediatric nutritional formula. 64.0b
2 Analytical Technique 85.0b
Reproducibility (RSDR) 0.5b ≤32%
Any analytical technique that meets the following method
performance requirements is acceptable. 21.5b ≤16%
b
43.0
3 Definitions
64.0b
Adult/pediatric formula.—Nutritionally complete, specially 85.0b
formulated food, consumed in liquid form, which may constitute a
Concentrations apply to (1) “ready-to-feed” liquids “as is”; (2) recon-
the sole source of nourishment (AOAC SPIFAN, 2010), made stituted powders (25 g into 200 g water); and (3) liquid concentrates
from any combination of milk, soy, rice, whey, hydrolyzed diluted 1:1 by weight.
b
protein, starch, and amino acids, with and without intact protein. μg/100 g expressed as folic acid in reconstituted final product.
Infant formula.—Breast-milk substitute specially
manufactured to satisfy, by itself, the nutritional requirements
of infants during the first months of life up to the introduction of
5 System Suitability Tests and/or Analytical Quality
appropriate complementary feeding (Codex Standard 72-1981),
Control
made from any combination of milk, soy, rice, whey, hydrolyzed
protein, starch, and amino acids, with and without intact protein. Suitable methods will include blank check samples and
Limit of detection (LOD).—The minimum concentration or check standards at the lowest point and midrange point of the
mass of analyte that can be detected in a given matrix with no analytical range.
greater than 5% false-positive risk and 5% false-negative risk.
Limit of quantitation (LOQ).—The minimum concentration 6 Reference Material(s)
or mass of analyte in a given matrix that can be reported as a National Institute of Standards and Technology (NIST)
quantitative result. Standard Reference Material (SRM) 1849 Infant/Adult
Repeatability.—Variation arising when all efforts are made Nutritional Formula, or equivalent. The SRM is a milk-
to keep conditions constant by using the same instrument and based, hybrid infant/adult nutritional powder prepared by a
operator, and repeating during a short time period. Expressed manufacturer of infant formula and adult nutritional products.
as the repeatability standard deviation (SDr); or % repeatability A unit of SRM 1849 consists of 10 packets, each containing
relative standard deviation (%RSDr). approximately 10 g of material. Certified value of folic acid in
Reproducibility.—The SD or RSD calculated from among- NIST 1849 is 2.11 (±0.13) mg/kg.
laboratory data; expressed as the reproducibility standard Note: The reference value for NIST 1849 is defined in
deviation (SDR), or % reproducibility relative standard deviation terms of folic acid. The performance parameters in this
(%RSDR). SMPR are intended for folate and 5-methyl-tetrahydrofolate
Recovery.—The fraction or percentage of spiked analyte that polyglutamate. Some discrepancy may be expected.
is recovered when the test sample is analyzed using the entire
method. 7 Validation Guidance
Recommended level of validation: Official Methods of
AnalysisSM.
8 Maximum Time-to-Signal
Submitted for publication November 2011.
Approved by: Stakeholder Panel on Infant Formula and Adult No maximum time.
Nutritionals (SPIFAN). Final Version Date: April 5, 2011. Effective
Date: June 29, 2011.
DOI: 10.5740/jaoac.int.11-0442
