ISO 23443:2020 PDF

Overview

ISO 23443:2020 specifies a validated analytical method for the quantitative determination of β‑carotene and lycopene in infant formula and adult nutritionals (powders, ready‑to‑feed liquids and liquid concentrates) using reversed‑phase ultra‑high performance liquid chromatography (RP‑UHPLC) with UV‑visible detection. The standard covers sample preparation (saponification and liquid–liquid extraction), chromatographic separation on a C30 stationary phase, use of an apocarotenal internal standard, and calculation and reporting procedures. The method is equivalent to AOAC Official Method 2016.13 (β‑carotene and lycopene) and includes an informative Annex C for lutein determination (Annex C reproducibility does not meet one referenced requirement).

Key topics and technical requirements

• Scope and matrix: Infant formula and adult nutritional products in powder or liquid forms (reconstituted powders, ready‑to‑feed, concentrates).
• Analytical principle: Saponification with KOH, extraction with MTBE/THF and hexane, drying under nitrogen, reconstitution in 2‑propanol, separation by RP‑UHPLC (C30 column), UV‑Vis detection.
• Calibration and internal standard: Use of apocarotenal (β‑Apo‑8′‑carotenal) as internal standard for quantitation.
• Performance ranges:
  • Lycopene: 1 μg/100 g to 1 500 μg/100 g
  • β‑Carotene: 1 μg/100 g to 2 250 μg/100 g
  • Single‑laboratory LOD: 0.1 μg/100 g; LOQ: 0.3 μg/100 g for each carotenoid
• Limitations:
  • Method does not apply where measurable levels of β‑apo‑8′‑carotenal are present (interferes with the internal standard).
  • Annex C (lutein) has reproducibility limitations compared to one reference requirement.
• Reproducibility: Reported reproducibility meets requirements cited in the standard (References [8] and [10]).

Practical applications and users

ISO 23443:2020 is intended for:

• Quality control and release testing by infant formula and adult nutritionals manufacturers
• Third‑party analytical laboratories performing compositional and label compliance testing
• Regulators and standardization bodies assessing nutritional claims and safety
• R&D teams developing fortified formulations containing carotenoids

Benefits include reliable quantitation of provitamin A (β‑carotene), lycopene content verification, and traceable, standardized reporting for product compliance and nutritional labelling.

Related standards

• AOAC Official Method 2016.13 - equivalent method for lutein, β‑carotene and lycopene (β‑carotene and lycopene Final Action)
• ISO/TC 34 publications on food testing and compositional analysis

Keywords: ISO 23443:2020, infant formula, adult nutritionals, β‑carotene, lycopene, lutein, RP‑UHPLC, carotenoids, UHPLC, C30 column, UV‑Vis detection, analytical method.