ISO/FDIS 23723

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

Médecine traditionnelle chinoise -- Exigences générales relatives aux matières premières issues des plantes et à la matière médicale

General Information

• Status: 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: 04-May-2021
• Completion Date: 04-May-2021

Standards Content (sample)

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 23723
ISO/TC 249
Traditional Chinese Medicine —
Secretariat: SAC
General requirements for herbal raw
Voting begins on:
2021­05­04 material and materia medica
Voting terminates
on: 2021­06­29
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
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 23723:2021(E)
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. ISO 2021
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ISO/FDIS 23723:2021(E)
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© ISO 2021

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ii © ISO 2021 – All rights reserved
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ISO/FDIS 23723:2021(E)
Contents Page

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

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

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 General principle ................................................................................................................................................................................................. 2

5 Requirements for all Chinese materia medica ...................................................................................................................... 3

5.1 General ........................................................................................................................................................................................................... 3

5.2 Identification ............................................................................................................................................................................................ 3

5.3 Quality requirements ........................................................................................................................................................................ 3

5.3.1 Moisture and loss on drying .................................................................................................................................. 3

5.3.2 Foreign matter ................................................................................................................................................................... 3

5.4 Safety requirements ........................................................................................................................................................................... 3

5.4.1 Heavy metals and arsenic ........................................................................................................................................ 3

5.4.2 Pesticide residues ........................................................................................................................................................... 3

6 Requirements for specific Chinese materia medica ........................................................................................................ 3

6.1 Quality requirements ........................................................................................................................................................................ 3

6.1.1 Total ash and acid­insoluble ash ........................................................................................................................ 3

6.1.2 Assay .................. .................................................... ..................................................................................................................... 4

6.1.3 Extractives ............................................................................................................................................................................. 4

6.1.4 Essential oil .......................................................................................................................................................................... 4

6.1.5 Rancidity ................................................................................................................................................................................. 4

6.1.6 Degree of colouration .................................................................................................................................................. 4

6.2 Safety requirements ........................................................................................................................................................................... 4

6.2.1 Sulfur dioxide residues ............................................................................................................................................... 4

6.2.2 Aflatoxins ................................................................................................................................................................................ 4

6.2.3 Aristolochic acids ............................................................................................................................................................ 4

6.2.4 Aconitum alkaloids ........................................................................................................................................................ 4

6.2.5 Microbial contamination ........................................................................................................................................... 4

7 Methods ......................................................................................................................................................................................................................... 5

7.1 Identification ............................................................................................................................................................................................ 5

7.1.1 Macroscopic identification ...................................................................................................................................... 5

7.1.2 Microscopic identification ....................................................................................................................................... 5

7.1.3 TLC identification and HPLC identification .............................................................................................. 5

7.2 Quality tests ............................................................................................................................................................................................... 5

7.2.1 Moisture and loss on drying .................................................................................................................................. 5

7.2.2 Foreign matter ................................................................................................................................................................... 5

7.2.3 Total ash and acid­insoluble ash ........................................................................................................................ 5

7.2.4 Assay .................. .................................................... ..................................................................................................................... 5

7.2.5 Extractives ............................................................................................................................................................................. 5

7.2.6 Essential oil .......................................................................................................................................................................... 6

7.2.7 Rancidity ................................................................................................................................................................................. 6

7.2.8 Degree of colouration .................................................................................................................................................. 7

7.3 Safety test .................................................................................................................................................................................................... 7

7.3.1 Heavy metal and arsenic ........................................................................................................................................... 7

7.3.2 Pesticide residues ........................................................................................................................................................... 7

7.3.3 Sulfur dioxide residues ............................................................................................................................................... 7

7.3.4 Aflatoxins ................................................................................................................................................................................ 7

7.3.5 Aristolochic acids ............................................................................................................................................................ 7

7.3.6 Aconitum alkaloids ........................................................................................................................................................ 7

7.3.7 Microbial contamination ........................................................................................................................................... 7

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ISO/FDIS 23723:2021(E)

8 Sampling ........................................................................................................................................................................................................................ 7

9 Test report ................................................................................................................................................................................................................... 8

10 Packaging ..................................................................................................................................................................................................................... 8

11 Labelling ........................................................................................................................................................................................................................ 8

12 Storage and transportation ....................................................................................................................................................................... 8

Annex A (informative) Test information of single herbs in national and regional pharmacopoeias 9

Bibliography .............................................................................................................................................................................................................................98

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ISO/FDIS 23723:2021(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 non­governmental, 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 2021 – All rights reserved v
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ISO/FDIS 23723:2021(E)
Introduction

Chinese herbal medicine, as an important component of traditional Chinese medicine, is widely used in

many countries because of its high value to human health and huge market. The annual sales of Chinese

herbal medicine are worth more than USD 16 billion and are 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 medicines, in order to ensure their quality and safety, and to

avoid misuse due to varietal complexity, harmful foreign matter and adverse drug reactions.

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

and rhizome. However, it is impractical to develop one­on­one standards for the thousands of species

of herbal medicine used in traditional Chinese medicine in the different traditions and regions. It is

preferable to have one International Standard of general requirements for herbal medicine, because

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

a) provide a standard for the species not covered in the existing International Standards for single

species of herbal medicine;

b) provide an outline and reference for International Standards for single species of herbal medicine.

The principles that were followed in preparing this document are as follows:

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

[1]

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

[2] [3] [4]
Pharmacopoeia, the Korean Pharmacopoeia and the European Pharmacopoeia ;

2) distill the common characteristics 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 standards.

The general requirements do not define general limit values. Annex A provides additional information

as it lists the monographs for specific herbs in national and regional pharmacopoeias, including the

items that are covered, meaning that limit values can be searched.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 23723:2021(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 provides minimum requirements for those herbal materials that are not covered by

individual standards.
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 °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 19609­2, Traditional Chinese medicine — Quality and safety of raw materials and finished products

made with raw materials — Part 2: Identity testing of constituents of herbal origin

ISO/TS 21310, Traditional Chinese medicine — Microscopic examination of medicinal herbs

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 22283, Traditional Chinese medicine — Determination of aflatoxins in natural products by LC-FLD

ISO 22467, Traditional Chinese Medicine — Determination of microorganism in natural products

ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration

ISO 23190, Traditional Chinese medicine — Determination of aristolochic acids in natural products by

HPLC

ISO 23191, Traditional Chinese medicine — Determination of selected Aconitum alkaloids by high-

performance liquid chromatography (HPLC)

World Health Organization. Quality Control Methods for Herbal Materials. World Health Organization,

2011
1) Under preparation. Stage at the time of publication: ISO/DIS 22467:2020.
2) Under preparation. Stage at the time of publication: ISO/FDIS 23190:2021.
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ISO/FDIS 23723:2021(E)
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

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

in traditional Chinese medicine 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 searching.

— 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 18662­1:2017, 3.1]
3.2
foreign matter

non-medicinal parts or components which can be carried or mixed in herbal raw material and materia

medica
EXAMPLE 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.

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

materials. These can be loose or adhering to these herbal materials.
4 General principle

For single herbs with existing International Standards, these International Standards apply.

For single herbs without existing International Standards, this document applies.

For single herbs with existing International Standards, but in which some requirements are not

specified, this document applies.
Requirements in Chapter 5 shall apply to all herbal materials.

Requirements in Chapter 6 shall apply to some specific herbal materials, of which the test items

covered by monographs of national and regional pharmacopoeias are listed in Table A.1 of Annex A for

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ISO/FDIS 23723:2021(E)

information. The herbal name, pharmaceutical name, regional expressions and English name of these

herbal materials are listed in Table A.2 of Annex A for information.
5 Requirements for all Chinese materia medica
5.1 General

The presence of mouldy plant material, obvious deterioration of physical appearance, external

contaminants and living insects which are visible to the naked eye shall not be permitted.

The presence of mouldy smells or taste shall not be permitted.
5.2 Identification
The identify shall be authenticated based on one of the following:
— macroscopic features of the whole material, fragmented material or both;
— microscopic features of the powdered material;

— a thin layer chromatography (TLC) or high-performance liquid chromatography (HPLC) fingerprint

to verify the presence of characteristic compounds and, where applicable, to exclude characteristic

compounds of known adulterations.
5.3 Quality requirements
5.3.1 Moisture and loss on drying
The content of water or loss on drying shall be determined.
5.3.2 Foreign matter
The percentage and nature of foreign matter shall be determined.
5.4 Safety requirements
5.4.1 Heavy metals and arsenic

The content of heavy metals such as lead, cadmium, mercury and arsenic shall be determined.

5.4.2 Pesticide residues
The content of pesticide residues listed in ISO 22258 shall be determined.
6 Requirements for specific Chinese materia medica
6.1 Quality requirements
6.1.1 Total ash and acid-insoluble ash

To limit the content of inorganic impurities (such as clay and sand) in some specific herbal materials,

the content of total ash and acid insoluble ash shall be determined.
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ISO/FDIS 23723:2021(E)
6.1.2 Assay

For some specific herbal materials that contain chemical substance(s) that serve as marker compounds,

an assay shall be applied.
6.1.3 Extractives

For some specific herbal materials, the content of water-soluble extractive, ethanol-soluble extractive

or ether-soluble extractives shall be determined.
6.1.4 Essential oil

For some specific herbal materials containing volatile oils, the content of essential oil shall be

determined.
6.1.5 Rancidity

For some specific herbal materials containing volatile oils or fatty oils which are liable to become

rancid, rancidity shall be determined.
6.1.6 Degree of colouration

For some specific herbal materials containing volatile oils or fatty oils which are liable to get oil

extravasation, degree of colouration shall be determined.
6.2 Safety requirements
6.2.1 Sulfur dioxide residues

For some specific herbal materials where the contamination with sulfur dioxide is a known safety issue,

sulfur dioxide shall be determined.
6.2.2 Aflatoxins

For some specific herbal materials where the contamination with aflatoxins is a known safety issue,

aflatoxin B and total aflatoxins shall be determined according to ISO 22283.
6.2.3 Aristolochic acids

For some specific herbal materials originated from the Aristolochia genus, aristolochic acids shall be

determined according to ISO 23190 .
6.2.4 Aconitum alkaloids

For some specific herbal materials originated from the Aconitum genus, aconitum alkaloids shall be

determined according to ISO 23191.
6.2.5 Microbial contamination

For some specific herbal materials where the contamination with microorganism is a known safety

issue, microbial contamination shall be determined.
3) Under preparation. Stage at the time of publication: ISO/FDIS 23190:2021.
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ISO/FDIS 23723:2021(E)
7 Methods
7.1 Identification
7.1.1 Macroscopic identification

Macroscopic identification includes shape, size, colour, texture, odour and taste of herbal material.

Perform macroscopic identification according to ISO 19609-2.
7.1.2 Microscopic identification
The testing method specified in ISO/TS 21310 applies.
7.1.3 TLC identification and HPLC identification

The testing method specified in monographs of existing national or regional pharmacopoeias applies.

7.2 Quality tests
7.2.1 Moisture and loss on drying

The testing method of water content specified in the World Health Organization's Quality Control

Methods for Herbal Materials applies.
The testing method of loss on drying specified in ISO 1573 applies.
7.2.2 Foreign matter

Weigh a quantity of the substance to be examined and spread it out in a thin layer. Examine for foreign

matter by inspection with the unaided eye or by use of a lens (5× to 10×). To separate the foreign matter,

a suitable sieve can be used if necessary. Weigh separately each kind of foreign matter and calculate its

percentage content.

NOTE 1 When the foreign matter closely resembles the official drug and it is difficult to distinguish between

them, the microscopical, chemical or physical methods can be used to identify the foreign matter.

Cut the big crude drugs and examine for the occurrence of insects, mould and deterioration.

NOTE 2 Unless otherwise specified, the quantity of substance to be examined for the determination of foreign

matter is in accordance with the requirements for the sampling of crude drugs.
7.2.3 Total ash and acid-insoluble ash

The testing methods specified in ISO 1575 and ISO 1577 apply for total ash and acid-insoluble ash,

respectively.
7.2.4 Assay

For chemical characterization, an assay can be suitable if methods and technologies are available, for

example, in monographs of existing national or regional pharmacopoeias. When the method of a certain

pharmacopoeia is chosen, the limit value of that pharmacopoeia monograph shall apply.

7.2.5 Extractives

Extractives include water-soluble extractives, ethanol-soluble extractives and ether-soluble extractives.

The testing methods specified in the World Health Organization's Quality Control Methods for Herbal

Materials apply.
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ISO/FDIS 23723:2021(E)
7.2.6 Essential oil

Weigh the quantity of the test sample for analysis in a 1-l hard glass-stoppered flask and add from

5 times to 10 times as much water as the drug. Set up the apparatus for essential oil determination

(Figure 1), inserting the left-lower mouth (1) into the flask and inserting a reflux condenser into the

upper mouth (2), then heat the contents of the flask in an oil bath of between 130 °C and 150 °C to

boiling. Fill the graduated tube of the apparatus with water to the standard line (3) and add 2,0 ml of

xylene. Unless otherwise specified, continue boiling for 5 hours, allow to stand for some time and open

the stopper of the apparatus. Draw off the water slowly until the surface of the oil layer corresponds to

the preparation line (4) and allow it to stand for more than 1 hour at ordinary temperature. Then lower

the surface of the oil layer to the zero line and read the volume (ml) of the oil at ordinar

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