ISO/TS 13126:2023

TECHNICAL ISO/TS
SPECIFICATION 13126
First edition
2023-02
Traditional Chinese medicine —
Determination of ochratoxin A
in natural products by liquid
chromatography coupled with
fluorescence detector
Médecine traditionnelle chinoise — Détermination de l'ochratoxine A
dans les produits naturels par chromatographie liquide couplée à un
détecteur de fluorescence
Reference number
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 1
5 Reagents . 1
6 Apparatus . 2
7 Sampling preparation.2
8 Test method . 3
8.1 Stock solution and working solution . 3
8.2 LC-FLD conditions . 3
8.2.1 General . 3
8.2.2 LC-FLD conditions and system suitability . . 3
8.2.3 Quantification of OTA in the test sample using calibration curves. 3
8.3 Application of test method . 3
9 Sampling and preservation .3
9.1 Sampling . 3
9.2 Sample storage . 4
Annex A (informative) Referenced analytical methods for determining OTA in different
countries and regions . 5
Annex B (informative) Referenced chromatogram for determination of OTA in natural
products using HPLC-FLD . 6
Annex C (informative) Recommended maximum residue limits (MRLs) of OTA in different
national, regional and organizational regulations . 7
Bibliography . 8
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
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.
v
TECHNICAL SPECIFICATION ISO/TS 13126:2023(E)
Traditional Chinese medicine — Determination of
ochratoxin A in natural products by liquid chromatography
coupled with fluorescence detector
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:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
ochratoxin
mycotoxin produced mainly by Aspergillus ochraceus, Aspergillus niger and Penicillium sp
Note 1 to entry: At least seven different types of ochratoxins are produced naturally. Ochratoxin A is known to be
highly toxic and carcinogenic.
Note 2 to entry: Ochratoxin A shall be tested and limited.
4 Abbreviated terms
HPLC high-performance liquid chromatography
LC-FLD liquid chromatography coupled with fluorescence detector
MRL maximum residue limit
OTA ochratoxin A
5 Reagents
The purity of the reagents used s
...