ISO 24976:2026
(Main)Traditional Chinese medicine — Pueraria lobata root
Traditional Chinese medicine — Pueraria lobata root
This document specifies the quality and safety requirements of Pueraria lobata root. This document applies to Pueraria lobata root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this root.
Médecine traditionnelle chinoise — Racine de Pueraria lobata
General Information
- Status
- Published
- Publication Date
- 29-Jan-2026
- Technical Committee
- ISO/TC 249 - Traditional Chinese medicine
- Current Stage
- 6060 - International Standard published
- Start Date
- 30-Jan-2026
- Due Date
- 21-Mar-2027
- Completion Date
- 30-Jan-2026
Overview
ISO 24976:2026 is an international standard developed by ISO for the quality and safety requirements of Pueraria lobata root, a widely used herb in traditional Chinese medicine (TCM). Commonly known as “Ge Gen,” Pueraria lobata root is recognized in global trade as both a whole medicinal material (Chinese materia medica) and in the form of decoction pieces. This standard ensures that Pueraria lobata root meets defined criteria for international commerce, supporting clinical efficacy, consistency, and safety for use in natural medicine.
Key Topics
ISO 24976:2026 covers a comprehensive framework on:
- Definitions and descriptions: Identification of Pueraria lobata root, including its botanical origin, macroscopic and microscopic features, and traditional processing steps.
- Quality requirements: Specifies criteria such as purity, physical characteristics, and content of marker compounds (e.g., puerarin).
- Safety requirements: Details parameters for controlling heavy metals, pesticide residues, aflatoxins, sulfur dioxide, and moisture content.
- Testing and analysis: Includes methods for the sampling, identification, and quantification of active ingredients, as well as impurity limits using techniques like thin-layer chromatography (TLC) and high-performance liquid chromatography (HPLC).
- Labelling and documentation: Provides guidelines for package marking, labelling, and traceability in accordance with ISO standards.
- Packaging, storage, and transportation: Outlines criteria to prevent contamination and maintain product integrity during international distribution.
Applications
ISO 24976:2026 is highly relevant to stakeholders in the herbal medicine supply chain and international trade, including:
- Manufacturers and processors of Pueraria lobata root and its decoction pieces, supporting quality assurance and safety during production.
- Exporters and importers engaged in global trade of Pueraria lobata root, ensuring compliance with harmonized quality standards.
- Healthcare professionals and pharmacists, facilitating selection of reliable and standardized raw materials for herbal products.
- Regulatory authorities responsible for the control and registration of traditional Chinese medicinal products.
- Testing laboratories and quality control experts, enabling standardized methods for component analysis and impurity detection based on validated procedures.
- Procurement entities seeking consistent supply of high-grade medicinal plant materials for research or clinical use.
Benefits of implementation include:
- Improved product safety and quality for consumers.
- Simplification of international transactions through harmonized criteria.
- Traceability from harvest to market, enhancing confidence in supply chain integrity.
- Facilitation of regulatory compliance when exporting to markets with established pharmacopoeia requirements.
Related Standards
ISO 24976:2026 references and aligns with several related ISO and national standards to provide a complete quality and safety management system, including:
- ISO 18664 – Determination of heavy metals in herbal medicines used in TCM
- ISO/TS 21310 – Microscopic examination of medicinal herbs
- ISO 21371 – Labelling requirements for oral/topical TCM products
- ISO 22217 – Storage requirements for raw materials and decoction pieces
- ISO 22258 – Determination of pesticide residues in natural products
- ISO 22283 – Determination of aflatoxins in natural products by LC-FLD
- ISO 22590 – Determination of sulfur dioxide in natural products by titration
- ISO 23723 – General requirements for herbal raw material and materia medica
ISO 24976:2026 also provides references to major pharmacopoeias from China, Japan, Korea, the UK, and the European Union, helping harmonize requirements for Pueraria lobata root across different jurisdictions.
Keywords: Pueraria lobata root, Ge Gen, ISO 24976:2026, traditional Chinese medicine standard, herbal medicine quality, decoction pieces, herbal product safety, international trade, TCM quality control, herbal medicine testing.
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Frequently Asked Questions
ISO 24976:2026 is a standard published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine — Pueraria lobata root". This standard covers: This document specifies the quality and safety requirements of Pueraria lobata root. This document applies to Pueraria lobata root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this root.
This document specifies the quality and safety requirements of Pueraria lobata root. This document applies to Pueraria lobata root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this root.
ISO 24976:2026 is classified under the following ICS (International Classification for Standards) categories: 11.120.10 - Medicaments. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 24976:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
International
Standard
ISO 24976
First edition
Traditional Chinese medicine —
2026-01
Pueraria lobata root
Médecine traditionnelle chinoise — Racine de Pueraria lobata
Reference number
© ISO 2026
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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 1
5 Requirements . 3
5.1 General characteristics .3
5.2 Macroscopic features .3
5.3 Microscopic feature .3
5.4 Thin-layer chromatography (TLC) features .3
5.5 Characteristic fingerprint .3
5.6 Marker compounds .3
5.7 Ethanol-soluble extractive .4
5.8 Total ash .4
5.9 Acid-insoluble ash .4
5.10 Moisture .4
5.11 Foreign matter .4
5.12 Heavy metals .4
5.13 Pesticide residues .4
5.14 Sulfur dioxide . .4
5.15 Aflatoxins .4
6 Sampling . 4
7 Test methods . 4
7.1 Identification of macroscopic features .4
7.2 Identification of microscopic features .4
7.3 Identification of thin-layer chromatogram .4
7.4 Determination of characteristic fingerprint .5
7.5 Determination of marker compounds .5
7.6 Determination of ethanol-soluble extractive .5
7.7 Determination of total ash .5
7.8 Determination of acid-insoluble ash .5
7.9 Determination of moisture .5
7.10 Determination of foreign matter .5
7.11 Determination of heavy metals .5
7.12 Determination of pesticide residues .5
7.13 Determination of sulfur dioxide .5
7.14 Determination of aflatoxin .5
8 Test report . 5
9 Marking and labelling . 6
10 Packaging, storage and transportation . 6
Annex A (informative) Identification of thin-layer chromatogram . 7
Annex B (informative) Determination of characteristic fingerprint of Pueraria lobata root. 9
Annex C (informative) Determination of puerarin .13
Annex D (informative) Reference of national and regional requirements .15
Annex E (informative) Traditional classification of Pueraria lobata root for commercial trade . 17
Bibliography .18
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
Introduction
The medicinal history of Pueraria lobata root (Chinese Pinyin name: Ge Gen) dates back over 2 000 years.
Pueraria lobata root has been used as a traditional herbal medicine in China, Japan, South Korea, United
Kingdom and other countries. It has exhibited diverse therapeutic effects, such as antipyretic, hypolipidemic,
hypoglycemic and hypotensive, intended for the treatment of arrhythmia, myocardial ischemia, osteoporosis
etc.
The establishment of an International Standard for Pueraria lobata root is necessary to guarantee the
clinical effectiveness, safety and controllability in global commerce and trade.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.6, 5.8 and 5.10 in their national standards. Examples of national and regional values are given in Annex D.
In addition, grading information of Pueraria lobata root are given in Annex E.
v
International Standard ISO 24976:2026(en)
Traditional Chinese medicine — Pueraria lobata root
1 Scope
This document specifies the quality and safety requirements of Pueraria lobata root.
This document applies to Pueraria lobata root that is sold and used as natural medicine in international
trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this
root.
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 22283, Traditional Chinese medicine — Determination of aflatoxins in natural products by LC-FLD
ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration
ISO 23723, Traditional Chinese medicine — General requirements for herbal raw material and materia medica
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
Pueraria lobata root
dried root of Pueraria lobata (Willd.) Ohwi (Fam. Leguminosae) after primary processing
Note 1 to entry: Pueraria lobata root is harvested in autumn or winter. The primary processing includes washing,
cutting into small cubes or into thick slices when fresh, and drying in the sun or in the oven (usually below 60 °C).
4 Descriptions
Pueraria lobata root is the dried root of Pueraria lobata (Willd.) Ohwi. (Fam. Leguminosae) as shown in
Figure 1.
a) inflorescence of Pueraria lobata b) leaf of Pueraria lobata c) root of Pueraria lobata
d) inner side of thick slice (Pueraria lobata root)
e) outer surface of thick slice (Pueraria lobata root)
g) microscopic features of root transverse
f) small cubes (Pueraria lobata root)
section of Pueraria lobata
Key
1 cork
2 fibre bundle
3 phloem
4 xylem ray
5 xylem
Figure 1 — Structure of Pueraria lobata root
5 Requirements
5.1 General characteristics
The following requirements shall be met before sampling:
a) the sample shall be clean and free from rootlets;
b) the presence of living insects, mouldy root and rhizome, and external contaminants which are visible to
the naked eye shall not be permitted.
5.2 Macroscopic features
5.2.1 Tuberous root, wholly cylindric-like and thick. Usually in thick, longitudinally cut slice, or in small
irregular cube, variable in size. Externally brown, with longitudinal wrinkles (Figure 1).
5.2.2 Odourless. Taste slightly sweetish.
5.2.3 Transverse section rough, pale yellowish-brown, several concentric annular rings indistinctly
visible. Texture tough, pliable and strongly fibrous.
5.3 Microscopic feature
Examine the transverse section under a microscope. Fibre bundles multiple, associated with the vessels,
surrounded by parenchyma cells containing prisms of calcium oxalate, appearing as crystal fibres. Phloem
and xylem are arranged alternately as hetero-vascular bundles; vessels distinct, numerous, densely and
alternately arranged with fibre bundles, rays narrow, a few of starch granules in the parenchyma [see
Figure 1 g)].
5.4 Thin-layer chromatography (TLC) features
...




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