ISO/TS 13126:2023 漢方薬 — 蛍光検出器と組み合わせた液体クロマトグラフィーによる天然物中のオクラトキシン A の測定 | ページ 2

Foreword

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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.

Introduction

Ochratoxins are naturally occurring mycotoxins produced by certain fungi, which can be found in a variety of agriculture products, contaminated foods and natural medicines, including natural products, decoction pieces and manufactured products. Ochratoxins are a class of compounds produced by a variety of Aspergillus ochraceus, Aspergillus niger and Penicillium sp. According to their discovery sequence, they are called ochratoxin A (OTA), ochratoxin B (OTB) and ochratoxin C (OTC). Among these, OTA is considered the most toxic. It has been well established that OTA is highly toxic and carcinogenic. The toxicity of OTA to animals and humans mainly includes kidney toxicity, liver toxicity, teratogenesis, carcinogenesis, mutation and immunosuppression. There are frequent reports of detection of toxic OTA in natural products. Therefore, there is a need to standardize the test method of OTA in natural products, which will bring benefits to the consumers, enterprises and companies in processing, management and trade of natural products. There are two main methods to detect OTA in natural products: the liquid chromatography tandem mass spectrometry (LC-MS/MS) method and the liquid chromatography coupled with fluorescence detector (LC-FLD) method. LC-FLD is preferred due to its high sensitivity, high accuracy and reasonable operating cost.

As national implementation can differ, examples of national, regional and organizational analytical methods and values are given in Annex A and Annex C.

1 Scope

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.

2 Normative references

There are no normative references in this document.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

Bibliography