ISO/FDIS 5106

Traditional Chinese medicine — Polygala tenuifolia and Polygala sibirica root

This document specifies minimum requirements and test methods for Polygala tenuifolia and Polygala sibirica root. This document applies to Polygala tenuifolia and Polygala sibirica root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.

Titre manque

General Information

• Status: Not Published
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 5000 - FDIS registered for formal approval
• Start Date: 25-Oct-2024
• Completion Date: 09-Oct-2024

Standards Content (Sample)

FINAL DRAFT
International
Standard
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Polygala tenuifolia and Polygala
Voting begins on:
sibirica root
2024-11-25
Voting terminates on:
2025-01-20
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Polygala tenuifolia and Polygala
Voting begins on:
sibirica root
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . . 2
5 Quality and safety requirements and recommendations . 4
5.1 General characteristics .4
5.2 Macroscopic characteristics .4
5.3 Microscopic characteristics .4
5.3.1 Transverse section . . .4
5.3.2 Powder .4
5.4 Moisture .5
5.5 Total ash .5
5.6 Thin layer chromatogram . .5
5.7 Ethanol-soluble extractives .5
5.8 Content of marker compound(s) .5
5.9 Mycotoxins .5
5.10 Heavy metals .5
5.11 Pesticide residues .5
5.12 Sulfur dioxide residues . .5
6 Sampling . 5
7 Test methods . 5
7.1 Macroscopic identification .5
7.2 Thin-layer chromatographic identification .5
7.3 Determination of moisture .5
7.4 Determination of total ash and acid-insoluble ash .6
7.5 Determination of ethanol-soluble extractives .6
7.6 Determination of marker compound(s).6
7.7 Determination of mycotoxins .6
7.8 Determination of heavy metals .6
7.9 Determination of pesticide residues .6
7.10 Determination of sulfur dioxide residues .6
8 Test report . 6
9 Packaging, storage and transportation . 6
10 Marking and Labelling . 7
Annex A (informative) Thin-layer chromatographic identification . 8
Annex B (informative) Determination of marker compound(s) .10
Annex C (informative) National and regional requirements for Polygala root .13
Bibliography .15

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 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 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
Polygala root is the dried root of Polygala tenuifolia Willd. or Polygala sibirica L. (Polygalaceae). It has the
functions of soothing the nerves, promoting heart and kidney health, removing phlegm, and reducing
swelling. It is used for insomnia, dreaminess, trance, uncomfortable expectoration, sore swelling, breast
swelling and pain. The medicinal materials, decoction pieces and extracts of Polygala root are widely sold
in China, Japan, Republic of Korea, Southeast Asia, North America and other regions. Polygala root has
been included in Chinese Pharmacopoeia, Japanese Pharmacopoeia, Korean Pharmacopoeia and European
Pharmacopoeia, but their requirements and test methods are different. Besides, there are traditional
Chinese medicine (TCM) such as Liriope spicata root on the market, which is usually confused with Polygala
root; and the aflatoxins in Polygala root may exceed the maximum residue limit if stored improperly. In
addition, the grade of medicinal materials is not linked to the intrinsic quality. These problems can affect
the international trade of Polygala root. Therefore, it is necessary to establish an International Standard to
bring benefits to the consumers, enterprises and companies involved in the processing, management and
trade of Polygala tenuifolia and Polygala sibirica root, and ensure its quality and safety.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.5 in their national standards. Examples of national and regional values are given in Annex C.

v
FINAL DRAFT International Standard ISO/FDIS 5106:2024(en)
Traditional Chinese medicine — Polygala tenuifolia and
Polygala sibirica root
1 Scope
This docum
...

ISO/TC 249/WG 1
Secretariat: SAC
Date: 2024-09-3011-08
Traditional Chinese medicine— — Polygala tenuifolia and Polygala
sibirica root
FDIS stage
ISO/DISFDIS 5106:2024(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
EmailE-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO #### – All rights reserved

Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . 2
5 Quality and safety requirements and recommendations . 4
5.1 General characteristics . 4
5.2 Macroscopic characteristics . 5
5.3 Microscopic characteristics. 5
5.4 Moisture . 5
5.5 Total ash . 6
5.6 Thin layer chromatogram . 6
5.7 Ethanol-soluble extractives. 6
5.8 Content of marker compound(s) . 6
5.9 Mycotoxins . 6
5.10 Heavy metals . 6
5.11 Pesticide residues . 6
5.12 Sulfur dioxide residues . 6
6 Sampling . 6
7 Test methods . 6
7.1 Macroscopic identification . 6
7.2 Thin-layer chromatographic identification . 6
7.3 Determination of moisture . 6
7.4 Determination of total ash and acid-insoluble ash . 7
7.5 Determination of ethanol-soluble extractives . 7
7.6 Determination of marker compound(s) . 7
7.7 Determination of mycotoxins . 7
7.8 Determination of heavy metals . 7
7.9 Determination of pesticide residues . 7
7.10 Determination of sulfur dioxide residues . 7
8 Test report . 7
9 Packaging, storage and transportation . 7
10 Marking and Labelling . 8
Annex A (informative) Thin-layer chromatographic identification . 9
Annex B (informative) Determination of marker compound(s) . 12
Annex C (informative) National and regional requirements for Polygala root . 16
Bibliography . 18

iii
ISO/DISFDIS 5106:2024(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 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 © ISO #### – All rights reserved

Introduction
Polygala root is the dried root of Polygala tenuifolia Willd. or Polygala sibirica L. (Polygalaceae). It has the
functions of soothing the nerves, promoting heart and kidney health, removing phlegm, and reducing swelling.
It is used for insomnia, dreaminess, trance, uncomfortable expectoration, sore swelling, breast swelling and
pain. The medicinal materials, decoction pieces and extracts of Polygala root are widely sold in China, Japan,
Republic of Korea, Southeast Asia, North America and other regions. Polygala root has been included in
Chinese Pharmacopoeia, Japanese Pharmacopoeia, Korean Pharmacopoeia and European Pharmacopoeia, but
their requirements and test methods are different. Besides, there are traditional Chinese medicine (TCM) such
as Liriope spicata root on the market, which is usually confused with Polygala root; and the aflatoxins in
Polygala root may exceed the maximum residue limit if stored improperly. In addition, the grade of medicinal
materials is not linked to the intrinsic quality. These problems can affect the international trade of Polygala
root. Therefore, it is necessary to establish an International Standard to bring benefits to the consumers,
enterprises and companies involved in the processing, management and trade of Polygala tenuifolia and
Polygala sibirica root, and ensure its quality and safety.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.55.5 in their national standards. Examples of national and regional values are given in Annex CAnnex C.
v
DRAFT International Standard
Traditional Chinese medicine— — Polygala tenuifolia and Polygala
sibirica root
1 Scope
This document specifies the minimum requirements and test methods for Polygala tenuifolia and Polygala
sibirica root.
It applies to Polygala tenuifolia and Polygala sibirica root that are sold and used as natural medicines in
international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.
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 15378, Primary packaging materials for medicinal products — Particular requirements for the application
of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 22283, Traditional Chinese medicine — Determination of aflatoxins in natural products by LC-FLD
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
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:
— — ISO Online browsing platform: available at https://www.iso.org/obp
— — IEC Electropedia: available at https://www.electropedia.org/
3.1 3.1
root
the part of a higher plant growing under the stem in the soil
ISO/DISFDIS 5106:2024(en)
3.2 3.2
Polygala root
) of Polygala tenuifolia Willd. or Polygala sibirica L.
root (3.1
3.3 3.3
powder
fine particles of matter in a solid state
3.4 3.4
total ash
residue obtained after incineration at 525 °C ± 25 °C
[SOURCE: ISO 22584:2019, 3.3]
3.5 3.5
marker compound
chemical constituent within a medicinal herb that can be used to verify its quality
Note 1 to entry: Usually described as active ingredients or chemicals that confirm the correct botanical identity of the
starting material.
[SOURCE: IS0ISO 22586:2022, 3.2], modified — Note 2 to entry has been removed.]
3.6 3.6
reference medicine
authentic medicine from the Polygala root (3.2(3.1),), used for reference in TLC analyses of the sample
3.7 3.7
sample batch
samples collected from the same particular place at the same time
[SOURCE: ISO 21317:2019, 3.5]
4 Description
Polygala root is the dried root of Polygala tenuifolia Willd. and Polygala sibirica L. in the family of Polygalaceae
as shown in Figure 1Figure 1.
© ISO #### 2024 – All rights reserved
a) Plant of Polygala tenuifolia Willd. b) Polygala tenuifolia root
ISO/DISFDIS 5106:2024(en)
c) Plant of P
...