ISO/FDIS 25099

Traditional Chinese medicine — Curcuma phaeocaulis, Curcuma kwangsiensis and Curcuma wenyujin rhizome

This document specifies the minimum requirements and test methods of Curcuma phaeocaulis, Curcuma kwangsiensis, and Curcuma wenyujin rhizome that is derived from Curcuma phaeocaulis VaL, Curcuma kwangsiensis S.GLee et C.F.Liang or Curcuma wenyujin Y.H.Chen et C.Ling. It is appropriate for Curcuma phaeocaulis, Curcuma kwangsiensis, and Curcuma wenyujin rhizome that is sold and used as a natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.

Médecine traditionnelle chinoise — Rhizome de Curcuma phaeocaulis, Curcuma kwangsiensis et Curcuma wenyujin

General Information

• Status: Not Published
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 1 - Quality and safety of raw materials and traditional processing
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 20-Nov-2025
• Completion Date: 20-Nov-2025

Standards Content (Sample)

FINAL DRAFT
International
Standard
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Curcuma phaeocaulis, Curcuma
Voting begins on:
kwangsiensis and Curcuma wenyujin
2025-11-20
rhizome
Voting terminates on:
2026-01-15
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/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Curcuma phaeocaulis, Curcuma
Voting begins on:
kwangsiensis and Curcuma wenyujin
rhizome
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
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Quality and safety requirements and recommendations . 4
5.1 General characteristics .4
5.2 Morphological features .4
5.2.1 Curcuma phaeocaulis rhizome .4
5.2.2 Curcuma kwangsiensis rhizome .5
5.2.3 Curcuma wenyujin rhizome .5
5.3 Identification .5
5.3.1 Microscopic identification . . .5
5.3.2 Thin-layer chromatography (TLC) identification .8
5.3.3 High performance liquid chromatography (HPLC) identification .8
5.4 Moisture .8
5.5 Total ash .8
5.6 Acid-insoluble ash .8
5.7 Residual sulfur dioxide .8
5.8 Ethanol-soluble extractives .8
5.9 Essential oil.8
5.10 Marker compound(s) .8
5.11 Heavy metals .8
5.12 Pesticide residues .8
6 Sampling . 9
7 Test methods . 9
7.1 Macroscopic identification .9
7.2 Microscopic identification .9
7.3 Thin-layer chromatography (TLC) identification .9
7.4 High performance liquid chromatography (HPLC) identification.9
7.5 Determination of moisture .9
7.6 Determination of total ash .9
7.7 Determination of acid-insoluble ash .9
7.8 Determination of residual sulfur dioxide .9
7.9 Determination of ethanol-soluble extractives .9
7.10 Determination of essential oil . .9
7.11 Determination of marker compounds .9
7.12 Determination of heavy metals .9
7.13 Determination of pesticide residues .10
8 Test report .10
9 Packaging, storage and transportation . 10
10 Marking and labelling . 10
Annex A (informative) Thin-layer chromatography (TLC) identification .11
Annex B (informative) High performance liquid chromatography (HPLC) identification and
determination of germacrone content .13
Annex C (informative) Reference information of national and regional requirements .16
Bibliography . 17

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).
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
Curcuma rhizome, the dried rhizome of Curcuma phaeocaulis, Curcuma kwangsiensis and Curcuma wenyujin,
is widely used as a herbal medicine in China and many other countries. This herb is also known as “E’zhu”
or zedoray/zedoary. In traditional Chinese medicine, the herb can enhance blood circulation, alleviate chest
discomfort, and treat abdominal distension and pain. Modern pharmacological studies have demonstrated
that Curcuma rhizome exhibits good anti-tumour, anti-thrombotic, anti-inflammatory, and analgesic effects.
The market, yield, and trade volume of Curcuma rhizome develop rapidly in recent years.
Curcuma rhizome has been recorded in several pharmacopoeias and standards, including the Chinese
[1] [2] [3]
Pharmacopoeia , the Japanese Pharmacopoeia , the Korean Pharmacopoeia and the Hong Kong Chinese
[4]
Materia Medical Standards . The requirements and specifications in these standards vary. Therefore, it is
important to develop an International Standard for harmonizing the existing standards, as well as ensuring
the safety and effectiveness of Curcuma rhizome, which can benefit farmers, consumers, enterprises and
governments involved in the production, regulation and trade of this herb.
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 25099:2025(en)
Traditional Chinese medicine — Curcuma phaeocaulis,
Curcuma kwangsiensis and Curcuma wenyujin rhizome
1 Scope
This document specifies minimum requirements and test methods for Curcuma rhizome (Curcuma
phaeocaulis, Curcuma kwangsiensis and Curcuma wenyujin rhizome).
It is applicable to Curcuma rhizome that is sold and used as a natural medicine in international trade,
including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.
This document does not apply to the processing methods and processed products of Curcuma rhizome.
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
Curcuma rhizome
dried rhizome (3.2)
...

ISO/TC 249/SC 1
Secretariat: SAC
Date: 2025-08-2811-05
Traditional Chinese medicine — Curcuma phaeocaulis, Curcuma
kwangsiensis, and Curcuma wenyujin rhizome
FDIS stage
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
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Quality and safety requirements and recommendations . 6
5.1 General characteristics . 6
5.2 Morphological features . 6
5.3 Identification . 6
5.4 Moisture . 10
5.5 Total ash . 10
5.6 Acid-insoluble ash . 10
5.7 Residual sulfur dioxide . 11
5.8 Ethanol-soluble extractives. 11
5.9 Essential oil . 11
5.10 Marker compound(s) . 11
5.11 Heavy metals . 11
5.12 Pesticide residues . 11
6 Sampling . 11
7 Test methods . 11
7.1 Macroscopic identification . 11
7.2 Microscopic identification . 11
7.3 Thin-layer chromatography (TLC) identification . 11
7.4 High performance liquid chromatography (HPLC) identification . 11
7.5 Determination of moisture . 11
7.6 Determination of total ash . 11
7.7 Determination of acid-insoluble ash . 12
7.8 Determination of residual sulfur dioxide . 12
7.9 Determination of ethanol-soluble extractives . 12
7.10 Determination of essential oil . 12
7.11 Determination of marker compounds . 12
7.12 Determination of heavy metals . 12
7.13 Determination of pesticide residues . 12
8 Test report . 12
9 Packaging, storage and transportation . 12
10 Marking and labelling . 13
Annex A (informative) Thin-layer chromatography (TLC) identification. 14
Annex B (informative) High performance liquid chromatography (HPLC) identification and
determination of germacrone content . 16
Annex C (informative) Reference information of national and regional requirements . 21
Bibliography . 23

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).
Field Code Changed
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.
Field Code Changed
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
Curcuma rhizome, the dried rhizome of Curcuma phaeocaulis, Curcuma kwangsiensis and Curcuma wenyujin,
is widely used as a herbal medicine in China and many other countries. This herb is also known as “E’zhu” or
zedoray/zedoary. In traditional Chinese medicine, the herb can enhance blood circulation, alleviate chest
discomfort, and treat abdominal distension and pain. Modern pharmacological studies have demonstrated
that Curcuma rhizome exhibits good anti-tumour, anti-thrombotic, anti-inflammatory, and analgesic effects.
The market, yield, and trade volume of Curcuma rhizome develop rapidly in recent years.
Curcuma rhizome has been recorded in several pharmacopoeias and standards, including the Chinese
[ [1]] [ [2]] [ [3]]
Pharmacopoeia 1, , the Japanese Pharmacopoeia 2, , the Korean Pharmacopoeia 3 and the Hong Kong
[ [4]]
Chinese Materia Medical Standards 4. . The requirements and specifications in these standards vary.
Therefore, it is important to develop an International Standard for harmonizing the existing standards, as well
as ensuring the safety and effectiveness of Curcuma rhizome, which can benefit farmers, consumers,
enterprises and governments involved in the production, regulation and trade of this herb.
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
FINAL DRAFT International Standard ISO/FDIS 25099:2025(en)

Traditional Chinese medicine — Curcuma phaeocaulis, Curcuma
kwangsiensis and Curcuma wenyujin rhizome
1 Scope
This document specifies minimum requirements and test methods for Curcuma rhizome (Curcuma
phaeocaulis, Curcuma kwangsiensis and Curcuma wenyujin rhizome).
It is applicable to Curcuma rhizome that is sold and used as a natural medicine in international trade, including
Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.
This document does not apply to the processing methods and processed products of Curcuma rhizome.
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 Medicinemedicine — 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 3.1
Curcuma rhizome
dried rhizome (3.2(3.2)) of Curcuma phaeocaulis Valeton, Curcuma kwangsiensis S. G. Lee et C. F. Liang and
Curcuma wenyujin Y. H. Chen et C. Ling
Note 1 to entry: In China, Curcuma phaeocaulis, Curcuma kwangsiensis and Curcuma wenyujin are commonly known as
"Peng E’zhu", "Guangxi E’zhu", and "Wen E’zhu" in Chinese, respectively.
3.2 3.2
rhizome
creeping rootstalk
main stem of a plant that sends out roots and shoots from its nodes
[SOURCE: ISO 13615:2024, 3.2]
4 Descriptions
Figure 1Figure 1 illustrates the structure of Curcuma phaeocaulis, Curcuma kwangsiensis and Curcuma
wenyujin rhizomes, which are collected in winter when the stem and leaves wither, washed clean, steamed or
boiled thoroughly, dried in the sun or dried at a low temperature (not more than 60 °C), then the fibrous roots
and foreign matter are removed.
© ISO #### 2025 – All rights reserved
ISO/DISFDIS 25099:2025(en)
a) Curcuma phaeocaulis
b) Curcuma kwangsiensis
© ISO #### 2025 – All rights reserved
ISO/DISFDIS 25099:2025(en)
c) Curcuma wenyujin
Key
1 inflorescence
2 flower
3 rhizome
4 root tuber
5 cross section of rhizome
6 leaf
7 leaf sheath
Figure 1 — Structure of the plant and rhizome of Curcuma phaeocaulis, Curcuma kwangsiensis and
Curcuma wenyujin
5 Quality and safety requirements and recommendations
5.1 General characteristics
The following requirements shall be met before sampling.
a) a) Curcuma rhizome shall be clean and free from foreign matter.
b) b) The presence of living insects, moulds and external contaminants which are visible to the
naked eye shall not be permitted.
5.2 Morphological features
5.2.1 Curcuma phaeocaulis rhizome
It is ovoid, elongate ovoid, conical or elongate fusiform, with the apex frequently obtuse, the base obtuse and
rounded, 2 cm to 8 cm long and 1,5 cm to 4 cm in diameter. Externally, it is greyish-yellow to greyish-brown.
The upper part is conspicuously raised-annulated and has rounded and slightly dented rootlet scars, or
remaining rootlets. Some parts exhibit a row of concave bud scars and subrounded lateral rhizome scars on
each of the two sides, and some show knife cut traces. The texture is heavy and hard. The fracture is greyish-
brown to bluish-brown, waxy, and usually has greyish-brown powder attached. The bark and stele are easily
detachable, and the endodermal ring is deep brown. Its odour is slightly aromatic; its tast
...