ISO/DIS 23723

Traditional Chinese Medicine -- General requirements for herbal raw material and materia medica

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DRAFT INTERNATIONAL STANDARD
ISO/DIS 23723
ISO/TC 249 Secretariat: SAC
Voting begins on: Voting terminates on:
2020-08-13 2020-11-05
Traditional Chinese Medicine — General requirements for
herbal raw material and materia medica
ICS: 11.120.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
This document is circulated as received from the committee secretariat.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 23723:2020(E)
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 SUPPORTING DOCUMENTATION. ISO 2020
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ISO/DIS 23723
ISO/DIS 23723:2020(E)
Contents

Foreword .......................................................................................................................................................................... v

Introduction.................................................................................................................................................................... vi

1 Scope .......................................................................................................................................................................... 7

2 Normative references .......................................................................................................................................... 7

3 Terms and definitions .......................................................................................................................................... 8

4 General principle ................................................................................................................................................... 8

5 Recommended requirements for all CMM.................................................................................................. 9

5.1 General ...................................................................................................................................................................... 9

5.2 Identification ........................................................................................................................................................... 9

5.3 Quality requirements ........................................................................................................................................... 9

5.3.1 Moisture and loss of drying ......................................................................................................................... 9

5.3.2 Foreign matters ................................................................................................................................................ 9

5.4 Safety requirements ............................................................................................................................................. 9

5.4.1 Heavy metals and arsenic ............................................................................................................................. 9

5.4.2 Pesticide residues ........................................................................................................................................... 9

6 Requirements for specific CMM ........................................................................................................................ 9

6.1 Quality requirements ........................................................................................................................................... 9

6.1.1 Total ash and acid-insoluble ash ............................................................................................................... 9

6.1.2 Assay ................................................................................................................................................................. 10

6.1.3 Extractives ...................................................................................................................................................... 10

6.1.4 Essential oil ..................................................................................................................................................... 10

6.1.5 Rancidtiy ........................................................................................................................... 错误!未定义书签。

6.1.6 Degree of colouration ................................................................................................................................. 10

COPYRIGHT PROTECTED DOCUMENT

6.2 Safety requirements .......................................................................................................................................... 10

© ISO 2020

6.2.1 Sulfur dioxide residues .............................................................................................................................. 10

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

6.2.2 Aflatoxins......................................................................................................................................................... 10

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.

6.2.3 Aristolochic acids ......................................................................................................................................... 10

ISO copyright office
CP 401 • Ch. de Blandonnet 8

6.2.4 Aconitum alkaloids ...................................................................................................................................... 10

CH-1214 Vernier, Geneva
Phone: [phone]

6.2.5 Microbial contamination ........................................................................................................................... 10

Fax: [phone]
Email: [e-mail]

Website: www.iso.org 7 Methods .................................................................................................................................................................. 11

Published in Switzerland

7.1 Identification ........................................................................................................................................................ 11

ii © ISO 2020 – All rights reserved

7.1.1 Macroscopic identification ........................................................................................................................ 11

7.1.2 Microscopic identification......................................................................................................................... 11

7.1.3 TLC identification and HPLC identification ......................................................................................... 11

7.2 Quality tests .......................................................................................................................................................... 11

7.2.1 Moisture and loss of drying ...................................................................................................................... 11

7.2.2 Foreign matters ............................................................................................................................................. 11

7.2.3 Total ash and acid-insoluble ash .............................................................................................................. 11

7.2.4 Assay ................................................................................................................................................................. 11

7.2.5 Extractives ...................................................................................................................................................... 12

7.2.6 Essential oil ..................................................................................................................................................... 12

7.2.7 Rancidity .......................................................................................................................................................... 13

7.2.8 Degree of colouration ................................................................................................................................. 13

7.3 Safety test .............................................................................................................................................................. 13

7.3.1 Heavy metal and arsenic ............................................................................................................................ 13

7.3.2 Pesticide residues ........................................................................................................................................ 13

7.3.3 Sulfur dioxide residues .............................................................................................................................. 13

7.3.4 Aflatoxins......................................................................................................................................................... 13

© ISO #### – All rights reserved iii
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ISO/DIS 23723:2020(E)
Contents

Foreword .......................................................................................................................................................................... v

Introduction.................................................................................................................................................................... vi

1  Scope .................................................................................................................................................................... 7

2  Normative references .................................................................................................................................... 7

3  Terms and definiti ons .................................................................................................................................... 8

4  General principle ............................................................................................................................................. 8

5  Recommended requirements for all CMM ........................................................................................... 9

5.1  General ................................................................................................................................................................ 9

5.2  Identification ..................................................................................................................................................... 9

5.3  Quality requirements ..................................................................................................................................... 9

5.3.1  Moisture and loss of drying ......................................................................................................................... 9

5.3.2  Foreign matters ................................................................................................................................................ 9

5.4  Safety requirements ....................................................................................................................................... 9

5.4.1  Heavy metals and arsenic ............................................................................................................................. 9

5.4.2  Pesticide residues ........................................................................................................................................... 9

6  Requirements for specific CMM ................................................................................................................. 9

6.1  Quality requirements ..................................................................................................................................... 9

6.1.1  Total ash and acid-insoluble ash ............................................................................................................... 9

6.1.2  Assay ................................................................................................................................................................. 10

6.1.3  Extractives ...................................................................................................................................................... 10

6.1.4  Essential oil ..................................................................................................................................................... 10

6.1.5  Rancidtiy ........................................................................................................................... 错误!未定义书签。

6.1.6  Degree of colouration ................................................................................................................................. 10

6.2  Safety requirements .................................................................................................................................... 10

6.2.1  Sulfur dioxide residues .............................................................................................................................. 10

6.2.2  Aflatoxins......................................................................................................................................................... 10

6.2.3  Aristolochic acids ......................................................................................................................................... 10

6.2.4  Aconitum alkaloids ...................................................................................................................................... 10

6.2.5  Microbial contamination ........................................................................................................................... 10

7  Metho ds ............................................................................................................................................................ 11

7.1  Identification .................................................................................................................................................. 11

7.1.1  Macroscopic identification ........................................................................................................................ 11

7.1.2  Microscopic identification ......................................................................................................................... 11

7.1.3  TLC identification and HPLC identification ......................................................................................... 11

7.2  Quality tests .................................................................................................................................................... 11

7.2.1  Moisture and loss of drying ...................................................................................................................... 11

7.2.2  Foreign matters ............................................................................................................................................. 11

7.2.3  Total ash and acid-insoluble ash .............................................................................................................. 11

7.2.4  Assay ................................................................................................................................................................. 11

7.2.5  Extractives ...................................................................................................................................................... 12

7.2.6  Essential oil ..................................................................................................................................................... 12

7.2.7  Rancidity .......................................................................................................................................................... 13

7.2.8  Degree of colouration ................................................................................................................................. 13

7.3  Safety test ........................................................................................................................................................ 13

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ISO/DIS 23723:2020(E)

7.3.1  Heavy metal and arsenic ............................................................................................................................ 13

7.3.2  Pesticide residues ........................................................................................................................................ 13

7.3.3  Sulfur dioxide residues .............................................................................................................................. 13

7.3.4  Aflatoxins......................................................................................................................................................... 13

7.3.5  Aristolochic acids ......................................................................................................................................... 13

7.3.6  Aconitum alkaloids ...................................................................................................................................... 13

7.3.7  Microbial contamination ........................................................................................................................... 13

8  Sampling .......................................................................................................................................................... 13

9  Test report ...................................................................................................................................................... 14

10  Packaging ........................................................................................................................................................ 14

11  Labelling .......................................................................................................................................................... 14

12  Storage and transportation ...................................................................................................................... 15

Annex A (informative) Test information of single herbs in national and organizational

pharmacopoeias ........................................................................................................................................... 17

A.1  Test items ........................................................................................................................................................ 17

A.2  Herbal names ................................................................................................................................................. 91

Bibliography ............................................................................................................................................................... 136

iv © ISO 2020 – All rights reserved
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ISO/DIS 23723:2020(E)
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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

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.
© ISO 2020 – All rights reserved v
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ISO/DIS 23723:2020(E)
Introduction

At present, Chinese herbal medicine, as an important component of traditional Chinese medicine, has

been widely used in many countries because of its high value to human health and huge market. The

annual sale of Chinese herbal medicine has reached more than USD 16 billion and is increasing at a rate

of 10 % to 20 % per year with great future potential. Such great opportunities for trade call for

international standards specifying the requirements for herbal medicine, in order to ensure their

quality and safety, and to avoid misuses due to varietal complexity, harmful foreign matters, and

adverse drug reactions (ADR).

There are specific standards for important species, such as ISO 20409:2017 for Panax notoginseng root

and rhizome. However, it is impractical to develop one‐on‐one standards for thousands of species of

herbal medicine used in TCM in the different traditions and regions. It is wiser to develop one

international standard of general requirements for herbal medicine, because herbal medicines have

many aspects in common.
The purpose of this document is to:

1) provide a standard for the species not covered in the existing ISO individual standards for single

species of herbal medicine;

2) be used as an outline and reference for ISO individual standards for single species of herbal medicine

The principles that were followed in preparing the standard are:

1) cover all general requirements of herbal medicine recorded by national, regional and organizational

pharmacopoeia, such as the Pharmacopoeia of the People's Republic of China, the Japanese

Pharmacopoeia, the Korean Pharmacopoeia, the European Pharmacopoeia;

2) distill the common characters of herbal medicine and formulate general requirements;

3) fully consider and respect the testing method and specific requirements on national or regional

pharmacopoeias, legislation and norms.

As national implementation may differ, National Standards Bodies are invited to modify the limit values

of 5.3.1, 5.3.2, 5.4.1, 5.4.2, 6.1.1, 6.1.2, 6.1.3, 6.1.4, 6.1.5, 6.1.6, 6.2.1, 6.2.2, 6.2.3, 6.2.4, and 6.2.5 in their

national standards. Examples of national and regional values are given in Annex A.1. The limit value

should refer to the requirements of the regulatory bodies of the destination country or region. If there is

none, the limit value listed in relevant ISO standards, such as ISO 18664, ISO 1573, et al or one of the

national or regional pharmacopoeias, such the Pharmacopoeia of the People's Republic of China, the

European Pharmacopoeia, et al shall be chosen and the given method shall be applied.

vi © ISO 2020 – All rights reserved
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DRAFT INTERNATIONAL STANDARD ISO/DIS 23723:2020(E)
Traditional Chinese Medicine –General requirements for herbal
raw material and materia medica
1 Scope

This document specifies the general requirements and test methods for herbal raw material and

materia medica.

This document is applicable to provide minimum requirements for those herbal materials that are not

covered by individual standards. This document is applicable to developing the documents of herbal

raw materials, too.
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 1573, Tea ‐ Determination of loss in mass at 103 degrees C
ISO 1575, Tea - Determination of total ash
ISO 1577, Tea - Determination of acid-insoluble ash

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/DIS 19609‐2, Traditional Chinese medicine -- Quality and safety of natural materials and

manufacturing products made with natural materials -- Part 2: Identity testing

ISO/DTS 21310, Traditional Chinese medicine -- Microscopic examination on medicinal herbs

ISO/FDIS 22217, Traditional Chinese medicine --Storage requirements for raw materials and decoction

pieces

ISO/FDIS 22258, Traditional Chinese medicine- Determination of pesticide residues in natural products by

ISO/FDIS 22283, Traditional Chinese medicine -- Determination of Aflatoxins in natural products by LC-

FLD

ISO/DIS 22467, Traditional Chinese Medicine- Determination of microorganism in natural products

© ISO 2020 – All rights reserved 1
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ISO/DIS 23723:2020(E)

ISO/FDIS 22590, Traditional Chinese medicine- Determination of Sulfur Dioxide in natural products by

titration

ISO/DIS 23190, Traditional Chinese medicine – Determination of aristolochic acids in natural products by

HPLC

ISO/FDIS 23191, Traditional Chinese Medicine – Determination of selected Aconitum alkaloids by HPLC

World Health Organization: Quality control methods for herbal materials.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
Chinese Materia Medica (CMM)

medicinal parts of medicinal plants, animals and minerals after preliminary processing, which are used

in TCM as decoction pieces and raw materials to make decoction pieces

Note 1 to entry: The different nomenclatures of the Chinese Materia Medica in use are described as follows:

— Latin name: Latin pharmaceutical name of the Chinese Materia Medica. In the Latin name, the genus

name or genus name plus species name is followed by the applicable medicinal parts. Items are listed in

alphabetical order of the Latin name for easy and convenient search.

— Chinese name: Han (Chinese) character name of the Chinese Materia Medica. Han characters include

both the simplified character and the traditional character, which is given in parentheses.

— Pinyin name: Pinyin name (Chinese phonetic) of the Chinese Materia Medica. The “four tones” have

been added in Pinyin to facilitate practice by users. Pinyin syllabication (in parentheses) is provided to

facilitate correct pronunciation.

— Scientific name: Latin scientific name of the source of the Chinese Materia Medica.

— English name: Commonly used English name of the Chinese Materia Medica.
[SOURCE: ISO 18662‐1, 3.1]
3.2
Foreign matters

non‐medicinal parts or components which may be carried or mixed in herbal raw material and materia

medica, such as material consisting of any or all of the following:

— parts of the herbal material or materials other than those named with the limits specified for the

herbal material concerned;

— any organism, part or product of an organism, other than that named in the specification and

description of the herbal material concerned;
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ISO/DIS 23723:2020(E)

— mineral admixtures such as soil, stones, sand, and dust; and glass, metal and plastics or any other

extraneous ma
...