Analytical range 0.50–300b Limit of detection (LOD) ≤0.10b Standard Method Performance Requirements (SMPRs) for Folate in Infant Formula and Adult/ Limit of quantitation (LOQ) ≤0.50b Pediatric Nutritional Formula Repeatability (RSDr) 0.50–21.5 b ≤11% >21.5b ≤7% Recovery 90–110% Intended Use: Global Dispute Resolution Method Reproducibility (RSDR) 0.5–21.5b ≤32% >21.5 b ≤16% 1 Applicability a Concentrations apply to (1) “ready-to-feed” liquids “as is”; Determination of total folate [supplemental folic acid (CAS 59- (2) reconstituted powders (25 g into 200 g water); and (3) liquid concentrates diluted 1:1 by weight. 30-3) and/or 5-methyl-tetrahydrofolate (CAS 68792-52-9), b µg/100 g expressed as folic acid in reconstituted final product. endogenous 5-methyl-tetrahydrofolate polyglutamates, 5-formyl- tetrahydrofolate, and 5-formyl-tetrahydrofolate polyglutamates] in all forms (powders, ready-to-feed liquids, and liquid concentrates) of infant, adult, and pediatric nutritional formula. Reproducibility.—The SD or RSD calculated from among- 2 Analytical Technique laboratory data; expressed as the reproducibility standard deviation (SDR), or % reproducibility relative standard deviation (%RSDR). Any analytical technique that meets the following method Recovery.—The fraction or percentage of spiked analyte that is performance requirements is acceptable. recovered when the test sample is analyzed using the entire method. 3 Definitions 4 Method Performance Requirements
Adult/pediatric formula.—Nutritionally complete, specially See Table 1.
formulated food, consumed in liquid form, which may constitute 5 System Suitability Tests and/or Analytical Quality Control the sole source of nourishment (AOAC SPIFAN, 2010), made Suitable methods will include blank check samples and check from any combination of milk, soy, rice, whey, hydrolyzed protein, standards at the lowest point and midrange point of the analytical starch, and amino acids, with and without intact protein. range. Infant formula.—Breast-milk substitute specially manufactured 6 Reference Material(s) to satisfy, by itself, the nutritional requirements of infants during the first months of life up to the introduction of appropriate National Institute of Standards and Technology (NIST) Standard complementary feeding (Codex Standard 72-1981), made from any Reference Material (SRM) 1849a Infant/Adult Nutritional Formula, combination of milk, soy, rice, whey, hydrolyzed protein, starch, or equivalent. The SRM is a milk-based, hybrid infant/adult and amino acids, with and without intact protein. nutritional powder prepared by a manufacturer of infant formula Limit of detection (LOD).—The minimum concentration or mass and adult nutritional products. A unit of SRM 1849a consists of 10 packets, each containing approximately 10 g of material. of analyte that can be detected in a given matrix with no greater than 5% false-positive risk and 5% false-negative risk. 7 Validation Guidance 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-Signal Repeatability.—Variation arising when all efforts are made to keep conditions constant by using the same instrument and No maximum time. operator, and repeating during a short time period. Expressed as the Approved by the AOAC Stakeholder Panel on Infant Formula repeatability standard deviation (SDr); or % repeatability relative and Adult Nutritionals (SPIFAN). Final Version Date: April 5, 2011. standard deviation (%RSDr). Effective Date: June 29, 2011. Revised March 2017.
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