ISO/FDIS 25660

Formatted: French (France)
ISO/DISFDIS 25660
Formatted: French (France)
ISO/TC 249/SC 1
Secretariat: SAC
Date: 2026-05-1307-20
Traditional Chinese medicine — Coix lacryma-jobi var. ma-yuen seed
DISFDIS stage
VVVoootttiiing bng bng beeegigiginsnsns o o on:n:n: 202 202 202555---101010---232323
VoVoVotintintinggg t t terererminminminatatateseses o o onnn:::  222000222666---000111---151515

ISO/DISFDIS 25660:2026(en)
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
Formatted: French (France)
E-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO/DISFDIS 25660:2026(en)
Contents
Foreword . iii
Introduction . iii
Scope . iii
Normative references . iii
Terms and definitions . iii
Coix lacrymajobi var . mayuen seed . iii
Descriptions . iii
Requirements and recommendations . iii
General characteristics . iii
Macroscopic characteristics . iii
Impurity . iii
Moisture . iii
Total ash . iii
Thin-layer chromatogram (TLC) identification . iii
Extractives . iii
Marker compound . iii
Aflatoxins . iii
Pesticide residues . iii
Heavy metals . iii
Sulfur dioxide . iii
Sampling . iii
Test methods . iii
Macroscopic identification . iii
Determination of moisture . iii
Determination of total ash . iii
Thin-layer chromatogram (TLC) identification . iii
Determination of marker compound . iii
Determination of aflatoxins . iii
Determination of pesticide residues . iii
Determination of heavy metals . iii
Determination of sulfur dioxide residues. . iii
Test report . iii
Package, storage and transportation . iii
Marking and labelling . iii
(informative) Determination of moisture content (drying in oven method) . iii
(informative) Thin-layer chromatogram (TLC) identification . iii
(informative) Determination of marker compounds . iii
(informative) Reference information of national and regional requirements on Coix lacryma-
jobi var. ma-yuen seed . iii
Bibliography . iii
Foreword . v
Introduction . vi
1 Scope . 1
iii
ISO/DISFDIS 25660:2026(en)
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements and recommendations . 4
5.1 General characteristics . 4
5.2 Macroscopic characteristics . 5
5.3 Impurity . 5
5.4 Moisture . 5
5.5 Total ash . 5
5.6 Thin-layer chromatogram (TLC) identification . 5
5.7 Extractives . 5
5.8 Marker compound . 5
5.9 Aflatoxins . 5
5.10 Pesticide residues . 5
5.11 Heavy metals . 5
5.12 Sulfur dioxide . 5
6 Sampling . 6
7 Test methods . 6
7.1 Macroscopic identification . 6
7.2 Determination of moisture . 6
7.3 Determination of total ash . 6
7.4 Thin-layer chromatogram (TLC) identification . 6
7.5 Determination of marker compound . 6
7.6 Determination of aflatoxins . 6
7.7 Determination of pesticide residues . 6
7.8 Determination of heavy metals . 6
7.9 Determination of sulfur dioxide residues. . 6
8 Test report . 6
9 Package, storage and transportation . 7
10 Marking and labelling . 7
Annex A (informative) Determination of moisture content (drying in oven method) . 8
Annex B (informative) Thin-layer chromatogram (TLC) identification . 9
Annex C (informative) Determination of marker compounds . 13
Annex D (informative) Reference information of national and regional requirements on Coix
lacryma-jobi var. ma-yuen seed . 16
Bibliography . 18

iv
ISO/DISFDIS 25660:2026(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent (s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 medicine, Subcommittee SC 1,
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.
v
ISO/DISFDIS 25660:2026(en)
Introduction
Coix lacryma-jobi var. ma-yuen seed, is the dried ripe seed of Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf
and is a well-known traditional Chinese medicine. Its Chinese phonetic name is Yiyiren. Currently, it is
commonly used as one of the main traditional Chinese medicines (TCMs) in over 100 prescriptions based on
its wide spectrum of biological and pharmacological activities, for treating edema, athlete's foot, poor
urination, cancer, spleen deficiency and diarrhea, etc. Coix lacryma-jobi var. ma-yuen seed oil extracted has
also been developed as an anti-tumor agent. The global import and export trade volume is huge with
sustainable growth in recent years, and the countries of trade mainly include Republic of Korea, Japan, United
Kingdom, United States, Australia, Thailand, Viet Nam, etc. However, the following concerns exist regarding
the quality and safety control of Coix lacryma-jobi var mayuen seed:
a) The processing method, storage pattern and operation technology of Coix lacryma-jobi var. ma-yuen seed
Formatted: Numbered + Level: 1 + Numbering Style: a,
have not been standardized, which can affect the quality and safety of medicinal materials.
b, c, … + Start at: 1 + Alignment: Left + Aligned at: 0
cm + Indent at: 0 cm
b) The requirements of Coix lacryma-jobi var. ma-yuen seed are different in different countries and regions,
Formatted: Numbered + Level: 1 + Numbering Style: a,
including China, Japan, Korea, America and Europe. The applicability of standards is limited and affects
b, c, … + Start at: 2 + Alignment: Left + Aligned at: 0
international trade.
cm + Indent at: 0 cm
c) Coix lacryma-jobi var. ma-yuen seed ranked the 136th in the priority list of single herbal medicines for
Formatted: Numbered + Level: 1 + Numbering Style: a,
developing standards in ISO/TR 23975:2025 .ISO/TR 23975:2025. b, c, … + Start at: 3 + Alignment: Left + Aligned at: 0
cm + Indent at: 0 cm
Therefore, an International Standard is needed for the quality control of Coix lacryma-jobi var. ma-yuen seed
and its products.
This document aims to build a systematic and practical international standard for Coix lacryma-jobi var. ma-
yuen seed to control and guarantee stable quality, to ensure the safety and effective use in clinic, to standardize
its products in global trade, and to reduce cases of mycotoxins pollution.
As national implementation can differ, national standards bodies are invited to modify the requirements given
in 5.4 and 5.5 in their national standards. Examples of national and regional values are given in Annex D.
vi
ISO/DISFDIS 25660:2026(en)
Traditional Chinese medicine — Coix lacryma-jobi var. ma-yuen seed
1 Scope
This document specifies requirements and test methods for Coix lacryma-jobi var. ma-yuen seed.
This document applies to Coix lacryma-jobi var. ma-yuen seeds that are sold and used as natural medicines in
international trade, including Chinese materia medica.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 1575, Tea — Determination of total ash
ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
ISO 22283, Traditional Chinese medicine — Determination of aflatoxins in natural products by LC-FLD
ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration
ISO 23723, Traditional Chinese medicine — General requirements for herbal raw material and materia medica
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:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
3.1
3.1 Coix lacrymajobi var. mayuen seed Formatted: Term(s)
dried ripe se
...