ISO 22283-2020 PDF

Full title and description

ISO 22283:2020 — Traditional Chinese medicine — Determination of aflatoxins in natural products by LC‑FLD. This International Standard specifies a liquid‑chromatography with fluorescence detection (LC‑FLD) method for identifying and quantifying aflatoxins (AFB1, AFB2, AFG1, AFG2) in raw materials and manufactured natural‑product medicines (including decoction pieces) derived from plants and animals.

Abstract

This document provides a validated LC‑FLD procedure for the determination of major aflatoxins in traditional Chinese medicine (TCM) natural products. It covers required reagents and apparatus, sample preparation and clean‑up, LC‑FLD operating conditions (including post‑column derivatization where applicable), calibration and quantification using calibration curves, system suitability, sampling, storage/preservation, and method validation guidance.

General information

• Status: Published.
• Publication date: 4 August 2020 (ISO publication date: 2020‑08 / 04‑Aug‑2020).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.120.10 (Medicaments / Traditional Chinese medicine).
• Edition / version: Edition 1 (First edition, 2020‑08).
• Number of pages: 13 pages.

Scope

The standard is applicable to the analysis of aflatoxins AFB1, AFB2, AFG1 and AFG2 in natural products and manufactured products used in traditional Chinese medicine, including decoction pieces derived from plant and animal sources. It specifies LC‑FLD analytical conditions and procedures suitable for routine control, compliance testing and laboratory quality assurance.

Key topics and requirements

• Target analytes: AFB1, AFB2, AFG1, AFG2 (aflatoxins of primary regulatory/toxicological concern).
• Analytical technique: liquid chromatography with fluorescence detection (LC‑FLD), including recommended columns and detector settings.
• Sample preparation and clean‑up procedures tailored to natural product matrices (homogenization, extraction, centrifugation, clean‑up steps).
• Post‑column derivatization and system suitability checks to enhance detection and ensure method performance.
• Quantification using calibration curves, limits of detection/quantification, and method validation guidance (see informative Annex D on validation).
• Sampling, storage and preservation requirements for test samples to avoid contamination or analyte loss.
• Informative annexes: full LC‑FLD method example, example chromatograms, compilation of national/regional aflatoxin limits for natural products, and method validation notes.

Typical use and users

Primary users are analytical and quality‑control laboratories testing traditional Chinese medicine (TCM) raw materials and finished products, TCM manufacturers implementing product safety controls, regulatory and food‑safety authorities assessing compliance, and research organizations studying mycotoxin contamination in herbal/natural products. The standard is intended for routine testing, method transfer and internal quality assurance.

Related standards

ISO 22283:2020 is an output of ISO/TC 249 (Traditional Chinese medicine) and relates to other international and national methods for mycotoxin determination (e.g., LC‑MS/MS methods and general mycotoxin standards). The published document’s annexes reference national and regional limits and related test methods; users should consult the ISO catalogue and their national standards body for complementary methods and regulatory specifications.

Keywords

aflatoxin; AFB1; AFB2; AFG1; AFG2; LC‑FLD; liquid chromatography; fluorescence detection; traditional Chinese medicine; natural products; mycotoxin; method validation; sampling; post‑column derivatization; quality control.

FAQ

Q: What is this standard?

A: ISO 22283:2020 is an International Standard that specifies an LC‑FLD analytical method for the determination of four major aflatoxins in natural products used in traditional Chinese medicine.

Q: What does it cover?

A: It covers reagents and apparatus, sample preparation and clean‑up, LC‑FLD conditions (including post‑column derivatization and system suitability), calibration and quantification, sampling and preservation, and method validation guidance plus informative annexes (example method, chromatograms, national limits, validation notes).

Q: Who typically uses it?

A: Analytical and QC laboratories, TCM manufacturers, regulatory authorities and research institutions involved in testing or assuring the safety and quality of natural‑product medicines.

Q: Is it current or superseded?

A: ISO 22283:2020 was published on 4 August 2020 and is the first (current) edition. ISO standards are subject to periodic review (typically every five years); consult ISO or your national standards body for any amendments or revisions since publication.

Q: Is it part of a series?

A: It is a standalone ISO International Standard developed under ISO/TC 249 (Traditional Chinese medicine). It sits alongside other ISO deliverables relevant to TCM safety, quality and analytical methods rather than being a numbered multi‑part series.

Q: What are the key keywords?

A: Aflatoxin; LC‑FLD; traditional Chinese medicine; mycotoxin; method validation; sampling; fluorescence detection; aflatoxin limits.