ISO 19836:2025

Traditional Chinese medicine — Platycodon grandiflorus root

This document specifies the minimum requirements and test methods for Platycodongrandiflorus root. It is applicable to Platycodon grandiflorus roots that are sold and used as natural medicines in international trade, including Chinese material medica (whole medicinal material) and decoction pieces derived from this plant.

Médecine traditionnelle chinoise — Racine de Platycodon grandiflorus

General Information

• Status: Published
• Publication Date: 22-Jul-2025
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 6060 - International Standard published
• Start Date: 23-Jul-2025
• Due Date: 15-Mar-2026
• Completion Date: 23-Jul-2025

Standards Content (Sample)

International
Standard
ISO 19836
First edition
Traditional Chinese medicine —
2025-07
Platycodon grandiflorus root
Médecine traditionnelle chinoise — Racine de Platycodon
grandiflorus
Reference number
© ISO 2025
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: [phone]
Email: [e-mail]
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 Description . 1
5 Quality and safety requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological features .2
5.2.1 Appearance .2
5.2.2 Colour .3
5.2.3 Dimensions .3
5.2.4 Fracture .3
5.3 Microscopic characteristics .3
5.3.1 Transverse section .3
5.3.2 Powder .4
5.4 Thin-layer chromatogram (TLC) identification .5
5.5 Moisture .5
5.6 Total ash .5
5.7 Acid-insoluble ash .5
5.8 Dilute ethanol-soluble extract .5
5.9 Marker compound(s) .6
5.10 Heavy metals .6
5.11 Pesticide residues .6
5.12 Sulfur dioxide .6
6 Sampling . 6
7 Test methods . 6
7.1 Macroscopic identification .6
7.2 Thin-layer chromatogram (TLC) identification .6
7.3 Microscopic identification .6
7.4 Determination of moisture .6
7.5 Determination of total ash .6
7.6 Determination of acid-insoluble ash .6
7.7 Determination of dilute ethanol-soluble extractives .6
7.8 Determination of platycodin D .6
7.9 Determination of heavy metals .7
7.10 Determination of pesticide residues .7
7.11 Determination of sulfur dioxide .7
8 Test report . 7
9 Packaging, storage and transportation . 7
10 Marking and labelling . 7
Annex A (informative) Thin-layer chromatogram (TLC) identification . 8
Annex B (informative) Determination of dilute ethanol-soluble extractives .10
Annex C (informative) Determination of platycodin D content .11
Annex D (informative) National and regional requirements for Platycodon grandiflorus 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 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.

iv
Introduction
Platycodon grandiflorus root, the dried root of Platycodon grandiflorus (Jacq.) A. De Candolle (Fam.
Campanulaceae), was first recorded in Shengnong Bencao in China and has a long history as a traditional
herbal medicine. It can improve the function of the lung and the pharynx and help relieve phlegm and
suppuration; it is used in the therapeutic treatment of cough, phlegm, sore throat and other pulmonary or
respiratory disorders. As a medicinal food homology species, Platycodon grandiflorus root has been used as
food and medicine for thousands of years in Asian countries, such as China, Japan and the Republic of Korea.
The quality of Platycodon grandiflorus root is crucial for its efficacy and safety. Although Platycodon
[1] [2]
grandiflorus root has been recorded in Chinese Pharmacopoeia, Japanese Pharmacopoeia, Korean
[3] [4] [5]
Pharmacopoeia, British Pharmacopoeia and European Pharmacopoeia, there have been no unique
requirements for Platycodon grandiflorus root. The establishment of an international standard for Platycodon
grandiflorus root, therefore, can help to promote international trade.
As national implementation can differ, national standards bodies can modify the value given in 5.6 in their
national standards. Examples of national and regional values are given in Annex D.

v
International Standard ISO 19836:2025(en)
Traditional Chinese medicine — Platycodon grandiflorus root
1 Scope
This document specifies the minimum requirements and test methods for Platycodongrandiflorus root.
It is applicable to Platycodon grandiflorus roots that are sold and used as natural medicines in international trade,
including Chinese material medica (whole medicinal material) and decoction pieces derived from this plant.
2 Normative r
...

FINAL DRAFT
International
Standard
ISO/FDIS 19836
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Platycodon grandiflorus root
Voting begins on:
2025-04-25
Voting terminates on:
2025-06-20
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
ISO/FDIS 19836:2025(en) © ISO 2025

FINAL DRAFT
ISO/FDIS 19836:2025(en)
International
Standard
ISO/FDIS 19836
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Platycodon grandiflorus root
Voting begins on:
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 2025
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
ISO/FDIS 19836:2025(en) © ISO 2025

ii
ISO/FDIS 19836:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . . 1
5 Quality and safety requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological features .2
5.2.1 Appearance .2
5.2.2 Colour .3
5.2.3 Dimensions .3
5.2.4 Fracture .3
5.3 Microscopic characteristics .3
5.3.1 Transverse section . . .3
5.3.2 Powder .4
5.4 Thin-layer chromatogram (TLC) identification .5
5.5 Moisture .5
5.6 Total ash .5
5.7 Acid-insoluble ash .5
5.8 Dilute ethanol-soluble extract .5
5.9 Marker compound(s) .6
5.10 Heavy metals .6
5.11 Pesticide residues .6
5.12 Sulfur dioxide . .6
6 Sampling . 6
7 Test methods . 6
7.1 Macroscopic identification .6
7.2 Thin-layer chromatogram (TLC) identification .6
7.3 Microscopic identification .6
7.4 Determination of moisture .6
7.5 Determination of total ash .6
7.6 Determination of acid-insoluble ash .6
7.7 Determination of dilute ethanol-soluble extractives .6
7.8 Determination of platycodin D .6
7.9 Determination of heavy metals .7
7.10 Determination of pesticide residues .7
7.11 Determination of sulfur dioxide .7
8 Test report . 7
9 Packaging, storage and transportation . 7
10 Marking and labelling . 7
Annex A (informative) Thin-layer chromatogram (TLC) identification . 8
Annex B (informative) Determination of dilute ethanol-soluble extractives .10
Annex C (informative) Determination of platycodin D content .11
Annex D (informative) National and regional requirements for Platycodon grandiflorus root .13
Bibliography .15

iii
ISO/FDIS 19836:2025(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, Traditionalmedicine, 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.

iv
ISO/FDIS 19836:2025(en)
Introduction
Platycodon grandiflorus root, the dried root of Platycodon grandiflorus (Jacq.) A. De Candolle (Fam.
Campanulaceae), was first recorded in Shengnong Bencao in China and has a long history as a traditional
herbal medicine. It can improve the function of the lung and the pharynx and help relieve phlegm and
suppuration; it is used in the therapeutic treatment of cough, phlegm, sore throat and other pulmonary or
respiratory disorders. As a medicinal food homology species, Platycodon grandiflorus root has been used as
food and medicine for thousands of years in Asian countries, such as China, Japan and
...

ISO/FDIS 19836:2025(en)
ISO/TC 249/SC 1
Secretariat: SAC
Date: 2025-03-1004-11
Traditional Chinese medicine – — Platycodon grandiflorus root
FDIS stage
ISO/FDIS 19836:2025(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/FDIS 19836:2025(en)
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 . 3
5.1 General characteristics . 3
5.2 Morphological features . 3
5.3 Microscopic characteristics. 3
5.4 Thin-layer chromatogram (TLC) identification . 7
5.5 Moisture . 7
5.6 Total ash . 7
5.7 Acid-insoluble ash . 7
5.8 Dilute ethanol-soluble extract . 7
5.9 Marker compound(s). 7
5.10 Heavy metals . 7
5.11 Pesticide residues . 7
5.12 Sulfur dioxide . 7
6 Sampling . 7
7 Test methods . 7
7.1 Macroscopic identification . 7
7.2 Thin-layer chromatogram (TLC) identification . 7
7.3 Microscopic identification . 7
7.4 Determination of moisture . 8
7.5 Determination of total ash . 8
7.6 Determination of acid-insoluble ash . 8
7.7 Determination of dilute ethanol-soluble extractives . 8
7.8 Determination of platycodin D . 8
7.9 Determination of heavy metals . 8
7.10 Determination of pesticide residues . 8
7.11 Determination of sulfur dioxide . 8
8 Test report . 8
9 Packaging, storage and transportation . 8
10 Marking and labelling . 9
Annex A (informative) Thin-layer chromatogram (TLC) identification . 10
Annex B (informative) Determination of dilute ethanol-soluble extractives . 12
Annex C (informative) Determination of platycodin D content . 13
Annex D (informative) National and regional requirements for Platycodon grandiflorus root . 16
Bibliography . 18

iii
ISO/FDIS 19836:2025(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.
iv
ISO/FDIS 19836:2025(en)
Introduction
Platycodon grandiflorus root, the dried root of Platycodon grandiflorus (Jacq.) A. De Candolle (Fam.
Campanulaceae), was first recorded in Shengnong Bencao in China and has a long history as a traditional
herbal medicine. It can improve the function of the lung and the pharynx and help relievingrelieve phlegm and
suppuration; it is used in the therapeutic treatment of cough, phlegm, sore throat and other pulmonary or
respiratory disorders. As a medicinemedicinal food homology species, Platycodon grandiflorus root has been
used as food and medicine for thousands of years in Asian countries, such as China, Japan and the Republic of
Korea.
The quality of Platycodon grandiflorus root is crucial for its efficacy and safety. Although Platycodon
[1]
grandiflorus root has been recorded in Chinese Pharmacopoeia (2020 edition),, Japanese Pharmacopoeia
th [2] th [3] [4]
(18 edition),, Korean Pharmacopoeia (12 edition),, British Pharmacopoeia (2022) and European
th [5]
Pharmacopoeia (11 edition),, there have been no unique requirements for Platycodon grandiflorus root.
The establishment of an international standard for Platycodon grandiflorus root is therefore necessarycan help
to promote international trade.
As national implementation can differ, national standards bodies are invited tocan modify the value given in
5.65.6 in their national standards. Examples of national and regional values are given in Annex DAnnex D.
v
FINAL DRAFT International Standard ISO/FDIS 19836:2025(en)

Traditional Chinese medicine – — Platycodon grandiflorus root
1 Scope
This document specifies the minimum requirements and test methods for Platycodon
grandiflorusPlatycodongrandiflorus root.
It is applicable to Platycodon grandiflorus roots that are sold and used as natural medicines in international
trade, including Chinese material medica (whole medicinal material) and decoction pieces derived from this
plant.
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 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO/TS 21310, Traditional Chinese medicine — Microscopic examination of medicinal herbs
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 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 3.1Platycodon
Platycodon grandiflorus root
dried root of Platycodon grandiflorus (Jacq.) A. DC.
3.2 3.2
marker compound
chemical constituent within a medicinal herb that can be used to verify its quality
ISO/FDIS 19836:2025(en)
4 Description
Platycodon grandiflorus root is the dried root of Platycodon grandiflorus (Jacq.) A. DC. in the family of
Campanulaceae, as shown in Figure 1Figure 1.

a) Plant of Platycodon grandiflorus (Jacq.) A. DC. b) Dried Platycodon grandiflorus root
Key
1 root
2 spray
3 leaf
ISO/FDIS 19836:2025(en)
Figure 1 — Structure of the plant and dried Platycodon grandiflorus root
5 Quality and safety requirements and recommendations
5.1 General characteristics
The following requirements shall be met before sampling.
a) a) Platycodon grandiflorus root shall be clean and free from leaf, stem and foreign matter.
b) b) The presence of living insects, mouldy roots and external contaminations which are visible to the
naked eye shall not be permitted.
5.2 Morphological features
5.2.1 Appearance
The whole root is cylindrical or slightly fusiform, gradually tapering downwards, sometimes branched, slightly
twisted. The surface contains longitudinally twisted furrows and rootlet scars or transverse lenticel-like scars;
the upper part of the root also shows transverse striations. Sometimes the upper part shows a relatively short
or inconspicuous rh
...