ISO 19661:2026

FINAL DRAFT
International
Standard
ISO/FDIS 19661
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Anemarrhena asphodeloides
Voting begins on:
rhizome
2025-11-17
Voting terminates on:
2026-01-12
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 19661:2025(en) © ISO 2025

FINAL DRAFT
ISO/FDIS 19661:2025(en)
International
Standard
ISO/FDIS 19661
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Anemarrhena asphodeloides
Voting begins on:
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 19661:2025(en) © ISO 2025

ii
ISO/FDIS 19661:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . . 1
5 Requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological feature .2
5.3 Microscopic characteristics .3
5.4 Thin-layer chromatogram (TLC) identification .3
5.5 Moisture .3
5.6 Total ash .3
5.7 Acid-insoluble ash .3
5.8 Heavy metals .3
5.9 Pesticide residues .4
5.10 Marker compounds .4
6 Sampling . 4
7 Test method . 4
7.1 Macroscopic identification .4
7.2 Microscopic identification .4
7.3 Thin-layer chromatogram (TLC) identification .4
7.4 Determination of moisture content .4
7.5 Determination of total ash content .4
7.6 Determination of acid-insoluble ash content .4
7.7 Determination of heavy metal contents .4
7.8 Determination of pesticide residues contents.4
7.9 Determination of marker compound .4
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatogram (TLC) identification . 6
Annex B (informative) Determination of marker compound . 7
Annex C (informative) Reference information of national and regional requirements . 9
Bibliography .10

iii
ISO/FDIS 19661:2025(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 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 19661:2025(en)
Introduction
Anemarrhena asphodeloides rhizome (also known as Anemarrhena Rhizoma, Zhimu in Mandarin) is one of
the commonly used herbal medicines in traditional Chinese medicine (TCM). For instance, of 1607 formulae
in Chinese Pharmacopoeia (2020 edition), 44 contain the Anemarrhena asphodeloides rhizome (accounting
for 2,74 %); among 148 kampo medicines for prescription from the Ministry of Health, Labour, and Welfare
(MHLW) of Japan, 6 formulae contain the Anemarrhena asphodeloides rhizome (accounting for 4,05 %).
[1]
Anemarrhena asphodeloides rhizome was firstly recorded in “Shen Nong Ben Cao Jing” , and has been used
in TCM for a long time for treatment of external contraction of febrile disease, high fever with vexation and
thirst, lung heat and dry cough, bone-steaming and tidal fever, interior heat wasting-thirst, constipation
caused by intestinal dryness. Phytochemical investigations have revealed that Anemarrhena asphodeloides
rhizome contains various chemical constituents, such as xanthones, steroidal saponins, flavones, xylogen,
tannins. Modern pharmacological studies have shown that the xanthones and steroidal saponins are the
main bioactive ingredients in Anemarrhena asphodeloides rhizome, which have the anti-diabetes, anti-
inflammation, anti-tumour, anti-platelet aggregation and anti-thrombotic formation, cardioprotective, and
cognition-enhancing effects.
In the global trade of Anemarrhena asphodeloides rhizome, China is the main export country. Based on the
statistics report of the Department of Market Supervision, Ministry of Commerce of the People's Republic
of China, from 2016 to 2020, the average annual export volume of Anemarrhena asphodeloides rhizome was
758 326,4 kilograms, worth USD 4 068 006. The main destination countries and regions included Japan,
Hong Kong, the Republic of Korea, Taiwan (Province of China), Malaysia, Viet Nam, New Zealand, Germany,
the United States and Thailand.
Anemarrhena asphodeloides rhizome has been recorded in the Pharmacopoeia of the People's Republic of
[2] [3] [4] [5]
China , the European Pharmacopoeia , the Japanese Pharmacopoeia and the Korean Pharmacopoeia ,
and the requirements of each pharmacopoeia are different. The standard of Anemarrhena asphodeloides
rhizome has not been unified at the international level. Therefore, the establishment of an International
Standard is necessary to guarantee the quality, safety, and consistency of the valuable herbal medicine.
As national and regional implementation can differ, national standards bodies are invited to modify the
values given in 5.6 and 5.7 in their national and regional standards. Examples of
...

ISO/FDIS 19661:2025(en)
ISO/TC 249/SC 1/WG 1
Secretariat: SAC
Date: 2025-09-1811-03
Traditional Chinese medicine— — Anemarrhena asphodeloides
rhizome
FDIS stage
ISO/FDIS 19661:2025(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: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO #### 2025 – All rights reserved
ii
ISO/FDIS 19661:2025(en)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . 1
5 Requirements and recommendations . 3
5.1 General characteristics . 3
5.2 Morphological feature . 3
5.3 Microscopic characteristics. 3
5.4 Thin-layer chromatogram (TLC) identification . 4
5.5 Moisture . 5
5.6 Total ash . 5
5.7 Acid-insoluble ash . 5
5.8 Heavy metals . 5
5.9 Pesticide residues . 5
5.10 Marker compounds . 5
6 Sampling . 5
7 Test method . 5
7.1 Macroscopic identification . 5
7.2 Microscopic identification . 5
7.3 Thin-layer chromatogram (TLC) identification . 5
7.4 Determination of moisture content . 5
7.5 Determination of total ash content . 5
7.6 Determination of acid-insoluble ash content . 5
7.7 Determination of heavy metal contents . 6
7.8 Determination of pesticide residues contents . 6
7.9 Determination of marker compound . 6
8 Test report . 6
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Thin-layer chromatogram (TLC) identification . 8
Annex B (informative) Determination of marker compound . 10
Annex C (informative) Reference information of national and regional requirements . 13
Bibliography . 15

iii
ISO/FDIS 19661:2025(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 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.
© ISO #### 2025 – All rights reserved
iv
ISO/FDIS 19661:2025(en)
Introduction
Anemarrhena asphodeloides rhizome (also known as Anemarrhena Rhizoma, Zhimu in Mandarin) is one of the
commonly used herbal medicines in traditional Chinese medicine (TCM). For instance, of 1607 formulae in
Chinese Pharmacopoeia (2020 edition), 44 contain the Anemarrhena asphodeloides rhizome (accounting for
2,74 %); among 148 kampo medicines for prescription from the Ministry of Health, Labour, and Welfare
(MHLW) of Japan, 6 formulae contain the Anemarrhena asphodeloides rhizome (accounting for 4,05 %).
[1 [1] ]
Anemarrhena asphodeloides rhizome was firstly recorded in “Shen Nong Ben Cao Jing” ” , , and has been used
in TCM for a long time for treatment of external contraction of febrile disease, high fever with vexation and
thirst, lung heat and dry cough, bone-steaming and tidal fever, interior heat wasting-thirst, constipation
caused by intestinal dryness. Phytochemical investigations have revealed that Anemarrhena asphodeloides
rhizome contains various chemical constituents, such as xanthones, steroidal saponins, flavones, xylogen,
tannins. Modern pharmacological studies have shown that the xanthones and steroidal saponins are the main
bioactive ingredients in Anemarrhena asphodeloides rhizome, which have the anti-diabetes, anti-
inflammation, anti-tumour, anti-platelet aggregation and anti-thrombotic formation, cardioprotective, and
cognition-enhancing effects.
In the global trade of Anemarrhena asphodeloides rhizome, China is the main export country. Based on the
statistics report of the Department of Market Supervision, Ministry of Commerce of the People's Republic of
China, from 2016 to 2020, the average annual export volume of Anemarrhena asphodeloides rhizome was
758 326,4 kilograms, worth USD 4 068 006. The main destination countries and regions included Japan, Hong
Kong, the Republic of Korea, Taiwan (Province of China), Malaysia, Viet Nam, New Zealand, Germany, the
United States and Thailand.
Anemarrhena asphodeloides rhizome has been recorded in the Pharmacopoeia of the People's Republic of
[2 [2]] [3 [3]] [4[4]]
China , , the European Pharmacopoeia , , the Japanese Pharmacopoeia and the Korean
[5 [5]]
Pharmacopoeia , , and the requirements of each pharmacopoeia are different. The standard of Anemarrhena
asphodeloides rhizome has not been unified at the international level. Therefore, the establishment of an
International Standard is necessary to guarantee the quality, safety, and consistency of the valuable herbal
medicine.
As national and regional implementation can differ, national standards bodies are invited to modify the values
given in 5.65.6 and 5.75.7 in their national and regional standards. Examples of national and regional values
are given in Annex CAnnex C.
v
FINAL DRAFT International Standard ISO/FDIS 19661:2025(en)

Traditional Chinese medicine — — Anemarrhena asphodeloides
rhizome
1 Scope
This document specifies the quality and safety requirements for Anemarrhena asphodeloides rhizome.
This document applies to Anemarrhena asphodeloides rhizome that is sold and used as natural medicines in
international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces
derived from the 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 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
Anemarrhena asphodeloides rhizome
dried rhizome of Anemarrhena asphodeloides Bunge
4 Description
Anemarrhena asphodeloides rhizome is collected in spring or autumn, with fibrous roots removed and dried
under the sun, or with th
...

FINAL DRAFT
International
Standard
ISO/FDIS 19661
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Anemarrhena asphodeloides
Voting begins on:
rhizome
2025-11-17
Voting terminates on:
2026-01-12
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 19661:2025(en) © ISO 2025

FINAL DRAFT
ISO/FDIS 19661:2025(en)
International
Standard
ISO/FDIS 19661
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Anemarrhena asphodeloides
Voting begins on:
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 19661:2025(en) © ISO 2025

ii
ISO/FDIS 19661:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . . 1
5 Requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological feature .2
5.3 Microscopic characteristics .3
5.4 Thin-layer chromatogram (TLC) identification .3
5.5 Moisture .3
5.6 Total ash .3
5.7 Acid-insoluble ash .3
5.8 Heavy metals .3
5.9 Pesticide residues .4
5.10 Marker compounds .4
6 Sampling . 4
7 Test method . 4
7.1 Macroscopic identification .4
7.2 Microscopic identification .4
7.3 Thin-layer chromatogram (TLC) identification .4
7.4 Determination of moisture content .4
7.5 Determination of total ash content .4
7.6 Determination of acid-insoluble ash content .4
7.7 Determination of heavy metal contents .4
7.8 Determination of pesticide residues contents.4
7.9 Determination of marker compound .4
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatogram (TLC) identification . 6
Annex B (informative) Determination of marker compound . 7
Annex C (informative) Reference information of national and regional requirements . 9
Bibliography .10

iii
ISO/FDIS 19661:2025(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 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 19661:2025(en)
Introduction
Anemarrhena asphodeloides rhizome (also known as Anemarrhena Rhizoma, Zhimu in Mandarin) is one of
the commonly used herbal medicines in traditional Chinese medicine (TCM). For instance, of 1607 formulae
in Chinese Pharmacopoeia (2020 edition), 44 contain the Anemarrhena asphodeloides rhizome (accounting
for 2,74 %); among 148 kampo medicines for prescription from the Ministry of Health, Labour, and Welfare
(MHLW) of Japan, 6 formulae contain the Anemarrhena asphodeloides rhizome (accounting for 4,05 %).
[1]
Anemarrhena asphodeloides rhizome was firstly recorded in “Shen Nong Ben Cao Jing” , and has been used
in TCM for a long time for treatment of external contraction of febrile disease, high fever with vexation and
thirst, lung heat and dry cough, bone-steaming and tidal fever, interior heat wasting-thirst, constipation
caused by intestinal dryness. Phytochemical investigations have revealed that Anemarrhena asphodeloides
rhizome contains various chemical constituents, such as xanthones, steroidal saponins, flavones, xylogen,
tannins. Modern pharmacological studies have shown that the xanthones and steroidal saponins are the
main bioactive ingredients in Anemarrhena asphodeloides rhizome, which have the anti-diabetes, anti-
inflammation, anti-tumour, anti-platelet aggregation and anti-thrombotic formation, cardioprotective, and
cognition-enhancing effects.
In the global trade of Anemarrhena asphodeloides rhizome, China is the main export country. Based on the
statistics report of the Department of Market Supervision, Ministry of Commerce of the People's Republic
of China, from 2016 to 2020, the average annual export volume of Anemarrhena asphodeloides rhizome was
758 326,4 kilograms, worth USD 4 068 006. The main destination countries and regions included Japan,
Hong Kong, the Republic of Korea, Taiwan (Province of China), Malaysia, Viet Nam, New Zealand, Germany,
the United States and Thailand.
Anemarrhena asphodeloides rhizome has been recorded in the Pharmacopoeia of the People's Republic of
[2] [3] [4] [5]
China , the European Pharmacopoeia , the Japanese Pharmacopoeia and the Korean Pharmacopoeia ,
and the requirements of each pharmacopoeia are different. The standard of Anemarrhena asphodeloides
rhizome has not been unified at the international level. Therefore, the establishment of an International
Standard is necessary to guarantee the quality, safety, and consistency of the valuable herbal medicine.
As national and regional implementation can differ, national standards bodies are invited to modify the
values given in 5.6 and 5.7 in their national and regional standards. Examples of
...

ISO/FDIS 19661:2025(en)
ISO/TC 249/SC 1/WG 1
Secretariat: SAC
Date: 2025-09-1811-03
Traditional Chinese medicine— — Anemarrhena asphodeloides
rhizome
FDIS stage
ISO/FDIS 19661:2025(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: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO #### 2025 – All rights reserved
ii
ISO/FDIS 19661:2025(en)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . 1
5 Requirements and recommendations . 3
5.1 General characteristics . 3
5.2 Morphological feature . 3
5.3 Microscopic characteristics. 3
5.4 Thin-layer chromatogram (TLC) identification . 4
5.5 Moisture . 5
5.6 Total ash . 5
5.7 Acid-insoluble ash . 5
5.8 Heavy metals . 5
5.9 Pesticide residues . 5
5.10 Marker compounds . 5
6 Sampling . 5
7 Test method . 5
7.1 Macroscopic identification . 5
7.2 Microscopic identification . 5
7.3 Thin-layer chromatogram (TLC) identification . 5
7.4 Determination of moisture content . 5
7.5 Determination of total ash content . 5
7.6 Determination of acid-insoluble ash content . 5
7.7 Determination of heavy metal contents . 6
7.8 Determination of pesticide residues contents . 6
7.9 Determination of marker compound . 6
8 Test report . 6
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Thin-layer chromatogram (TLC) identification . 8
Annex B (informative) Determination of marker compound . 10
Annex C (informative) Reference information of national and regional requirements . 13
Bibliography . 15

iii
ISO/FDIS 19661:2025(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).
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iv
ISO/FDIS 19661:2025(en)
Introduction
Anemarrhena asphodeloides rhizome (also known as Anemarrhena Rhizoma, Zhimu in Mandarin) is one of the
commonly used herbal medicines in traditional Chinese medicine (TCM). For instance, of 1607 formulae in
Chinese Pharmacopoeia (2020 edition), 44 contain the Anemarrhena asphodeloides rhizome (accounting for
2,74 %); among 148 kampo medicines for prescription from the Ministry of Health, Labour, and Welfare
(MHLW) of Japan, 6 formulae contain the Anemarrhena asphodeloides rhizome (accounting for 4,05 %).
[1 [1] ]
Anemarrhena asphodeloides rhizome was firstly recorded in “Shen Nong Ben Cao Jing” ” , , and has been used
in TCM for a long time for treatment of external contraction of febrile disease, high fever with vexation and
thirst, lung heat and dry cough, bone-steaming and tidal fever, interior heat wasting-thirst, constipation
caused by intestinal dryness. Phytochemical investigations have revealed that Anemarrhena asphodeloides
rhizome contains various chemical constituents, such as xanthones, steroidal saponins, flavones, xylogen,
tannins. Modern pharmacological studies have shown that the xanthones and steroidal saponins are the main
bioactive ingredients in Anemarrhena asphodeloides rhizome, which have the anti-diabetes, anti-
inflammation, anti-tumour, anti-platelet aggregation and anti-thrombotic formation, cardioprotective, and
cognition-enhancing effects.
In the global trade of Anemarrhena asphodeloides rhizome, China is the main export country. Based on the
statistics report of the Department of Market Supervision, Ministry of Commerce of the People's Republic of
China, from 2016 to 2020, the average annual export volume of Anemarrhena asphodeloides rhizome was
758 326,4 kilograms, worth USD 4 068 006. The main destination countries and regions included Japan, Hong
Kong, the Republic of Korea, Taiwan (Province of China), Malaysia, Viet Nam, New Zealand, Germany, the
United States and Thailand.
Anemarrhena asphodeloides rhizome has been recorded in the Pharmacopoeia of the People's Republic of
[2 [2]] [3 [3]] [4[4]]
China , , the European Pharmacopoeia , , the Japanese Pharmacopoeia and the Korean
[5 [5]]
Pharmacopoeia , , and the requirements of each pharmacopoeia are different. The standard of Anemarrhena
asphodeloides rhizome has not been unified at the international level. Therefore, the establishment of an
International Standard is necessary to guarantee the quality, safety, and consistency of the valuable herbal
medicine.
As national and regional implementation can differ, national standards bodies are invited to modify the values
given in 5.65.6 and 5.75.7 in their national and regional standards. Examples of national and regional values
are given in Annex CAnnex C.
v
FINAL DRAFT International Standard ISO/FDIS 19661:2025(en)

Traditional Chinese medicine — — Anemarrhena asphodeloides
rhizome
1 Scope
This document specifies the quality and safety requirements for Anemarrhena asphodeloides rhizome.
This document applies to Anemarrhena asphodeloides rhizome that is sold and used as natural medicines in
international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces
derived from the 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 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
Anemarrhena asphodeloides rhizome
dried rhizome of Anemarrhena asphodeloides Bunge
4 Description
Anemarrhena asphodeloides rhizome is collected in spring or autumn, with fibrous roots removed and dried
under the sun, or with th
...