ISO/TS 13126:2023 PDF

Name: ISO/TS 13126:2023 — Traditional Chinese medicine — Determination of ochratoxin A in natural products by liquid chromatography coupled with fluorescence detector
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Traditional Chinese medicine — Determination of ochratoxin A in natural products by liquid chromatography coupled with fluorescence detector

Название (английский):

ISO/TS 13126:2023

Traditional Chinese medicine — Determination of ochratoxin A in natural products by liquid chromatography coupled with fluorescence detector

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 8
Дата публикации:: 17 февраля 2023 г.
Издание:: ISO TS 13126 edition 1 version 1
ICS:: 11.120.10

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Описание (английский):

This document specifies the determination of ochratoxin A (OTA) in natural products by the liquid chromatography coupled with fluorescence detector (LC-FLD) method. It is applicable to the analysis of OTA in raw materials and manufactured products, including decoction pieces derived from plants and animals. It is suitable for samples during the processes of harvesting, transportation and storage, as well as domestic and foreign trade for quality classification.

Abstract

Похожие стандарты

Другие стандарты ISO

Overview

ISO/TS 13126:2023 - Traditional Chinese medicine - Determination of ochratoxin A in natural products by liquid chromatography coupled with fluorescence detector (LC‑FLD) - specifies a standardized laboratory method for detecting ochratoxin A (OTA) in natural products, including raw materials and manufactured decoction pieces derived from plants and animals. The technical specification targets quality control across harvesting, transportation, storage and domestic/foreign trade of traditional Chinese medicine (TCM) and other natural-product supply chains.

Key topics and technical requirements

Scope: Applicable to raw materials and manufactured products (decoction pieces) from plant and animal sources; suitable for samples in production, storage and trade.

Analytical approach: Liquid chromatography with fluorescence detection (LC‑FLD / HPLC‑FLD) is the recommended method for OTA due to sensitivity, accuracy and cost-effectiveness. LC‑MS/MS is noted as an alternative technique for multi‑mycotoxin analysis.

Sample preparation: Crush and sieve samples; extract 25.0 g powder with 4.0 g NaCl in 85 mL methanol:water (80:20), homogenize (>11 000 rpm, 2 min), centrifuge (4 000 rpm, 10 min), then immunoaffinity column clean‑up, elute with methanol and filter (0.22 µm).

LC‑FLD conditions: Use octadecylsilyl (C18) column; mobile phase acetonitrile–glacial acetic acid–water (isocratic); flow rate 1.0 mL/min; detector excitation λex = 333 nm and emission λem = 477 nm; chromatographic resolution between adjacent peaks > 1.5.

Calibration and quantification: Stock and working solutions covering 0.1–100 ng/mL; inject 25 µL for calibration curves plotting peak area vs concentration.

Sampling & storage: Batch sample minima (general materials ≥100 g, powdered ≥25 g, precious materials ≥5 g); store prepared samples in the dark at 4 °C and document chain of custody.

Validation: Method validated for liquorice extract/root; other matrices require method validation before routine use.

Applications and users

ISO/TS 13126:2023 is practical for:

Analytical and quality control laboratories testing OTA in TCM and natural products

TCM manufacturers and raw material suppliers implementing mycotoxin monitoring

Regulatory bodies and inspection agencies assessing compliance with maximum residue limits (MRLs)

Import/export quality control for domestic and international trade

Research groups validating analytical methods for herbal matrices

Benefits include harmonized test procedures, reproducible results for OTA monitoring, and support for consumer safety and trade conformity.

Related standards

Annex A lists referenced national and regional analytical methods (e.g., Chinese Pharmacopoeia, GB standards, AOAC, European and British Pharmacopoeias).

Annex C summarizes referenced MRLs used by different jurisdictions.

LC‑MS/MS methods are referenced as complementary techniques for multi‑mycotoxin analysis.

Keywords: ISO/TS 13126:2023, ochratoxin A, OTA, LC‑FLD, HPLC‑FLD, traditional Chinese medicine, natural products, immunoaffinity column, mycotoxin testing, method validation, MRLs.

ISO/TS 13126:2023 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

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