ISO 20638-2015 PDF

Full title and description

Infant formula — Determination of nucleotides by liquid chromatography. ISO 20638:2015 defines a validated HPLC method for the quantitative determination of 5′‑mononucleotides in infant formula in powder and liquid forms using liquid chromatography coupled with appropriate sample preparation and internal standardisation.

Abstract

ISO 20638:2015 specifies procedures for extracting, cleaning up and chromatographically separating 5′‑mononucleotides (for example UMP, CMP, AMP, GMP and IMP) from infant formula matrices (powders, ready‑to‑feed liquids and concentrates), and for quantifying them using an internal standard and HPLC detection. The document includes method principle, reagents, apparatus, sample preparation, chromatographic conditions, calculations, example chromatograms and precision data.

General information

• Status: Published (International Standard; later confirmed in ISO maintenance).
• Publication date: 9 November 2015 (ISO 20638:2015).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 67.050 — General methods of tests and analysis for food products.
• Edition / version: First edition (2015).
• Number of pages: 14 (ISO original document).

Key bibliographic and lifecycle metadata (publication date, ICS and page count) are recorded in the ISO catalogue and national adoption records.

Scope

Specifies a method for the quantitative determination of 5′‑mononucleotides in infant formula in solid (powder) or liquid (ready‑to‑feed and concentrates) forms by liquid chromatography, covering sample extraction and cleanup, chromatographic separation, detection and calculation of results. The method is intended for routine and regulatory testing of nucleotide content in infant nutrition products.

Key topics and requirements

• Analytes covered: principal 5′‑mononucleotides such as UMP, CMP, AMP, GMP and IMP.
• Sample types: powdered formulas, ready‑to‑feed liquids and liquid concentrates.
• Sample preparation: extraction into buffered/high‑salt solutions with chelating agents as required to reduce matrix interactions.
• Clean‑up: solid‑phase extraction (strong anion exchange) to remove interferences before chromatography.
• Chromatography: reversed‑phase C18 column with specified gradient/mobile phase conditions and column temperature control.
• Detection and quantitation: UV / photodiode‑array detection with an internal standard (commonly TMP) and calibration by peak‑area ratios; example chromatograms and calculation procedures are provided.
• Performance data: includes precision/reproducibility information (informative annex) and references to method accuracy practices (e.g., ISO/ISO‑related precision standards).

Technical details and typical chromatographic/reagent examples are provided in the body and informative annexes of the standard.

Typical use and users

Used by food and dairy analytical laboratories, infant formula manufacturers (quality control and R&D), regulatory and standards bodies, contract testing laboratories and method validation groups for routine analysis, specification testing and comparative studies of nucleotide content in infant nutrition products.

Related standards

Closely related to other ISO methods for infant formula and nutritional analysis (for example other ISO 2063x series standards covering vitamins, myo‑inositol and related analytes), and equivalent/related methods such as AOAC official methods for nucleotide determination; connections to general accuracy/precision standards (for example ISO 5725 series) are referenced for method validation and precision assessment.

Keywords

Infant formula, nucleotides, 5′‑mononucleotides, UMP, AMP, GMP, CMP, IMP, liquid chromatography, HPLC, solid‑phase extraction, internal standard, TMP, method validation, food analysis.

FAQ

Q: What is this standard?

A: ISO 20638:2015 is an International Standard that defines a liquid‑chromatography method for the quantitative determination of 5′‑mononucleotides in infant formula (powders and liquids).

Q: What does it cover?

A: It covers sample extraction, cleanup (SPE), chromatographic separation conditions, detection/quantitation using an internal standard, calculation of results, and provides example chromatograms and precision data.

Q: Who typically uses it?

A: Food testing and dairy laboratories, infant formula manufacturers (QC/R&D), regulatory laboratories and contract analytical labs performing compositional testing or compliance checks on infant nutrition products.

Q: Is it current or superseded?

A: The document was published on 9 November 2015 and the ISO record shows the standard confirmed in the ISO maintenance process (standard confirmed effective 23 April 2021). There is no indication in the ISO catalogue that it has been superseded as of the confirmation date; users should check the ISO catalogue or their national body for any later revisions or withdrawals.

Q: Is it part of a series?

A: It sits among a group of ISO methods for infant formula and adult nutritionals (other ISO 2063x publications) that specify analytical methods for vitamins, nutrients and other components; it is commonly referenced alongside general standards on measurement accuracy and method validation.

Q: What are the key keywords?

A: Infant formula, nucleotides, 5′‑mononucleotides, HPLC, solid‑phase extraction, internal standard, UMP, AMP, GMP, CMP, IMP.