ISO 7102:2024 PDF

Infant formula — Determination of β-galactooligosaccharides — Ultra high performance liquid chromatography (UHPLC) with fluorescence detection after pre-column derivatization

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Title (English):

ISO 7102:2024

Infant formula — Determination of β-galactooligosaccharides — Ultra high performance liquid chromatography (UHPLC) with fluorescence detection after pre-column derivatization

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 19
Publication date:: August 12, 2024
Edition:: ISO IS 7102 edition 1 version 1
ICS:: 67.050

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Description (English):

This document specifies a method for the determination of β-galactooligosaccharides (GOS) in infant formula (both powder and liquid) containing 0,2 g/100 g to 3,0 g/100 g of GOS in the product as prepared ready for consumption. The method has been validated in a multi-laboratory study with reconstituted infant formula at levels of 0,236 g/100 g, 0,594 g/100 g, 0,616 g/100 g and 0,688 g/100 g and infant formula RTF at levels of 0,316 g/100 g and 0,858 g/100 g. During the single laboratory validation study[1] spike-recovery experiments were performed up to 3 g/100 g in reconstituted infant formula powders (milk-based, partially hydrolysed milk-based and soy-based), and reconstituted adult nutritional powders.

Technical details

Technical committee: ISO/TC 34/SC 5 - Milk and milk products
SKU: ISO 7102:2024

Abstract

Overview

ISO 7102:2024 - Infant formula: Determination of β‑galactooligosaccharides (GOS) - specifies a validated analytical method to quantify β‑galactooligosaccharides (GOS) in infant formula (powder and ready‑to‑feed liquids). The procedure uses ultra high performance liquid chromatography (UHPLC) with fluorescence detection (FLD) after pre‑column derivatization with 2‑aminobenzamide (2AB). The method covers product concentrations from 0.2 g/100 g to 3.0 g/100 g (ready for consumption) and has been validated in multi‑laboratory and single‑laboratory studies.

Key topics and technical requirements

Sample scope: Powdered/concentrated infant formula (reconstituted) and ready‑to‑feed (RTF) liquids.
Analytical principle: Extraction of oligosaccharides, enzymatic hydrolysis (amyloglucosidase to remove maltooligosaccharides; β‑galactosidase for total GOS determination), internal standard addition (laminaritriose), fluorescent labelling with 2AB, UHPLC‑HILIC separation and FLD detection.
Calibration and quantification:
- External calibration with maltotriose (2AB response assumed equivalent molar response).
- Conversion from molar to mass concentrations requires molecular weight determination - via LC‑MS (Annex C) or dextran ladder (Annex B).
Chromatography: HILIC column with gradient of aqueous ammonium formate in acetonitrile (as mobile phase).
Enzymes and reagents: amyloglucosidase and β‑galactosidase (Aspergillus niger), 2AB, 2‑picoline borane, laminaritriose internal standard, maltotriose standard.
Validation data: Multi‑lab validation at ~0.236–0.688 g/100 g (reconstituted) and 0.316 & 0.858 g/100 g (RTF); spike‑recovery studies up to 3 g/100 g in various formula matrices.

Applications and users

Quality control and regulatory testing: Infant formula manufacturers and contract testing laboratories can use ISO 7102:2024 for routine GOS content verification and label compliance.
Product development and R&D: Nutrition scientists assessing prebiotic content or formulating GOS‑enriched products.
Regulatory authorities and food safety labs: For enforcement, compositional analysis and harmonized reporting.
Clinical nutrition and third‑party certification bodies: Verifying declared oligosaccharide levels in specialized formulas.

Keywords for discoverability: ISO 7102:2024, infant formula, β‑galactooligosaccharides, GOS analysis, UHPLC‑FLD, 2‑aminobenzamide derivatization, HILIC, maltotriose calibration, dextran ladder, method validation.

Related standards

Equivalent to AOAC Official Method 2021.01 (noted in the ISO/IDF foreword).
Developed under ISO/TC 34 (Food products), SC 5 (Milk and milk products) in collaboration with IDF and AOAC.

Related standards

Other ISO standards

Abstract

Overview

Key topics and technical requirements

Sample scope: Powdered/concentrated infant formula (reconstituted) and ready‑to‑feed (RTF) liquids.
Analytical principle: Extraction of oligosaccharides, enzymatic hydrolysis (amyloglucosidase to remove maltooligosaccharides; β‑galactosidase for total GOS determination), internal standard addition (laminaritriose), fluorescent labelling with 2AB, UHPLC‑HILIC separation and FLD detection.
Calibration and quantification:
- External calibration with maltotriose (2AB response assumed equivalent molar response).
- Conversion from molar to mass concentrations requires molecular weight determination - via LC‑MS (Annex C) or dextran ladder (Annex B).
Chromatography: HILIC column with gradient of aqueous ammonium formate in acetonitrile (as mobile phase).
Enzymes and reagents: amyloglucosidase and β‑galactosidase (Aspergillus niger), 2AB, 2‑picoline borane, laminaritriose internal standard, maltotriose standard.
Validation data: Multi‑lab validation at ~0.236–0.688 g/100 g (reconstituted) and 0.316 & 0.858 g/100 g (RTF); spike‑recovery studies up to 3 g/100 g in various formula matrices.

Applications and users

Quality control and regulatory testing: Infant formula manufacturers and contract testing laboratories can use ISO 7102:2024 for routine GOS content verification and label compliance.
Product development and R&D: Nutrition scientists assessing prebiotic content or formulating GOS‑enriched products.
Regulatory authorities and food safety labs: For enforcement, compositional analysis and harmonized reporting.
Clinical nutrition and third‑party certification bodies: Verifying declared oligosaccharide levels in specialized formulas.

Related standards

Equivalent to AOAC Official Method 2021.01 (noted in the ISO/IDF foreword).
Developed under ISO/TC 34 (Food products), SC 5 (Milk and milk products) in collaboration with IDF and AOAC.

ISO 7102:2024 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Related standards

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