ISO 24902:2026
(Main)Traditional Chinese medicine — Zanthoxylum nitidum root
- Abstract
This document specifies the minimum requirements and test methods for Zanthoxylum nitidum root. This document applies to Zanthoxylum nitidum root sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Status
- Published
- Publication Date
- 10-Aug-2026
- Technical Committee
- ISO/TC 249 - Traditional Chinese medicine
- Current Stage
- 6060 - International Standard published
- Start Date
- 11-Aug-2026
- Due Date
- 01-Mar-2027
- Completion Date
- 11-Aug-2026
ISO 24902:2026 is an International Standard published by ISO for Zanthoxylum nitidum root, the dried root of Zanthoxylum nitidum (Roxb.) DC. It specifies minimum requirements and test methods for the whole medicinal material and for decoction pieces used as Chinese materia medica, so manufacturers, laboratories, inspectors and buyers can check identity and quality against one common document. This is the first edition.
What does ISO 24902:2026 specify?
ISO 24902:2026 specifies the minimum requirements and test methods for Zanthoxylum nitidum root sold and used as Chinese materia medica and as decoction pieces derived from this plant. The document is organized into clauses on scope, normative references, terms and definitions, description, requirements and recommendations, sampling, test methods, test report, packaging and storage, and marking and labelling.
| Annex | What it covers |
|---|---|
| Annex A | Thin-layer chromatogram (TLC) identification, including Zanthoxylum nitidum root and toddalolactone identification |
| Annex B | Determination of marker compounds by HPLC-UV |
| Annex C | Reference information on national and regional quality requirements |
What are the key requirements of ISO 24902:2026?
ISO 24902:2026 focuses on identity, cleanliness, chemical markers and safe handling. In practice, this means the material has to look, test and be packed like genuine Zanthoxylum nitidum root before it is accepted for use.
Identity and appearance
Clause 5.1 requires the material to be clean and free from leaves, foreign matter, living insects, mouldy fruit and visible external contaminants. Clause 5.2 describes the expected form and appearance, including thick slices or cylindrical sections, pale brownish-yellow to yellowish surfaces, lenticel-like scars, a hard texture and a slightly aromatic odour. Clause 5.3 gives the microscopic characters used to confirm the root structure. These checks help screen out poor-quality lots and obvious substitutions before lab testing.
Chromatographic identification
Clause 5.4 requires TLC spots from the test solution to match the reference drug solution and not match toddalolactone CRS reference solution. In practice, this provides a quick identity check and also helps detect a common confusing substance. Annex A gives the working TLC procedures and figures for both the root and toddalolactone comparison.
Quality limits and chemical markers
Clauses 5.5 to 5.10 cover moisture, total ash, ethanol-soluble extractives, heavy metals, pesticide residues and marker compounds. The document sets a maximum moisture level, requires determination of total ash, and sets a minimum for ethanol-soluble extractives. It also requires control of heavy metals and pesticide residues, and it names nitidine chloride as the marker compound, with a stated minimum content calculated on dried drug. For real-world use, these values are the main lot-release checks for purity and consistency.
Sampling, testing and reporting
Clause 6 requires sampling in accordance with ISO 23723:2021, Clause 8. Clause 7 links each test to a method, including microscopic examination, moisture, total ash, heavy metals, pesticide residues and marker compounds. Clause 8 requires the test report to identify the sample, state the sampling and test methods, record results and note any unusual features or incidents. That makes the result traceable and usable in quality files, audits and dispute cases.
Packaging, storage and labelling
Clause 9 requires packaging and transport that do not transfer odour or flavour, damage the product or create a health risk, and it calls for protection from light, moisture, pollution and foreign substances. Clause 10 requires labelling of the quality features from Clause 5, plus gross mass, net mass, origin, production and expiry dates, and storage method. These requirements matter because the material can be affected by poor storage and because buyers need clear package information.
What terms does ISO 24902:2026 define?
- Zanthoxylum nitidum root - the dried root of Zanthoxylum nitidum (Roxb.) DC.
- Chinese materia medica - the medicinal plant material used in traditional Chinese medicine as sold in whole form.
- decoction pieces - processed pieces derived from the plant for use in decoctions.
- marker compound - nitidine chloride, the named chemical used for identity and content control.
- TLC - thin-layer chromatography, used here for identity checking by comparing spot position and colour.
- HPLC-UV - high-performance liquid chromatography with ultraviolet detection, used in Annex B to measure marker compounds.
- CRS - reference standard material used in the TLC and HPLC-UV procedures.
Who uses ISO 24902:2026?
ISO 24902:2026 is used by traditional Chinese medicine manufacturers, herbal raw-material suppliers, quality control laboratories, inspectors and purchasing teams. It supports incoming inspection, identity testing, batch release, adulteration screening, packaging checks and labelling review. It is also relevant to organizations that compare local specifications with international practice, especially where quality control of Zanthoxylum nitidum root is part of trade or regulatory work.
Which standards are used with ISO 24902:2026?
- ISO 23723:2021 - provides the general requirements for herbal raw material and materia medica, and supplies the sampling method plus methods for moisture, total ash and ethanol-soluble extractives.
- ISO/TS 21310 - provides the microscopic examination method used for Clause 7.2.
- ISO 18664 - provides the method for determination of heavy metals.
- ISO 22258 - provides the method for determination of pesticide residues by gas chromatography.
- ISO 22217:2020 - provides the storage requirements applied in Clause 9.
- ISO 21371 - provides the labelling requirements used in Clause 10.
What does the ISO 24902:2026 document contain?
ISO 24902:2026 contains a short descriptive section for the plant material, followed by requirements for visual, microscopic and chromatographic identification, plus chemical quality limits. It also contains the sampling rule, the linked test methods, and the reporting, packaging, storage and labelling requirements needed to handle the material in practice.
Annex A gives TLC procedures and chromatogram examples for identification work. Annex B gives an HPLC-UV method for nitidine chloride, including sample preparation, reference solution preparation and chromatographic conditions. Annex C summarizes reference quality requirements used in several national and regional standards for comparison.
Get Certified
Connect with accredited certification bodies for this standard
BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.
TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.
TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
Frequently Asked Questions
ISO 24902:2026 is a standard published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine — Zanthoxylum nitidum root". This standard covers: This document specifies the minimum requirements and test methods for Zanthoxylum nitidum root. This document applies to Zanthoxylum nitidum root sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
This document specifies the minimum requirements and test methods for Zanthoxylum nitidum root. This document applies to Zanthoxylum nitidum root sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
ISO 24902:2026 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 24902:2026 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 24902
First edition
Traditional Chinese medicine —
2026-08
Zanthoxylum nitidum root
Médecine traditionnelle chinoise — Racine de Zanthoxylum
nitidum
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
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
ii
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 features of root.2
5.3 Microscopic identification .3
5.4 Thin-layer chromatogram (TLC) identification .3
5.5 Moisture .4
5.6 Total ash .4
5.7 Ethanol-soluble extractives .4
5.8 Heavy metals .4
5.9 Pesticide residues .4
5.10 Marker compounds .4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification .4
7.2 Microscopic identification .4
7.3 Thin-layer chromatogram (TLC) identification .4
7.4 Determination of moisture .4
7.5 Determination of total ash .4
7.6 Toddalolactone identification .4
7.7 Determination of ethanol-soluble extractives .5
7.8 Determination of heavy metals .5
7.9 Determination of pesticide residues .5
7.10 Determination of marker compounds .5
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 compounds by HPLC-UV . 8
Annex C (informative) Reference information of national and regional requirements .10
Bibliography .12
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
Zanthoxylum nitidum root (the Chinese Pinyin name: Liang-Mian-Zhen) is the dried root of Zanthoxylum
nitidum (Roxb.) DC., which is known in China as Liang-Mian-Zhen. It is mainly distributed in southern China
and Viet Nam. Zanthoxylum nitidum root and its products are sold in China, Japan, Thailand, Myanmar,
Singapore, Malaysia, the United States, Uganda, and many other countries. It is widely used in traditional
Chinese medicine for treating stomachache, toothache, rheumatic arthralgia, traumatic injury, and venomous
snake bites. Additional medical applications include the treatment of inflammations, various types of cancer,
bacterial and viral infections, gastric and oral ulcers, and liver damage.
Zanthoxylum nitidum root contains a variety of effective chemical components, including alkaloids,
coumarins, lignans, sterols, flavonoids, and volatile oils, among which alkaloids have the highest content,
accounting for about 0,7 %. Modern pharmacological studies have shown that Zanthoxylum nitidum root has
anti-inflammatory, analgesic, antioxidant and anti-tumour effects. The anti-inflammatory and analgesic
effects of Zanthoxylum nitidum root are widely used in the treatment of bruises, stomach pain, toothache,
and rheumatism.
The alkaloids are the main active components of Zanthoxylum nitidum root. Nitidine chloride is one of the
most frequently used alkaloids in Zanthoxylum nitidum root to study its various pharmacological effects.
At the same time, studies have also shown that the alkaloids in Zanthoxylum nitidum root have a certain
degree of toxicity and can cause toxic effects such as hepatocyte toxicity, renal cytotoxicity, developmental
toxicity and cardiotoxicity.
On the market, the quality of Zanthoxylum nitidum root is uneven. There are forgeries and adulterations. The
common forgeries and confused products of Zanthoxylum nitidum root are the stem of Zanthoxylum nitidum
(Roxb.) DC. and roots from the plants of Toddalia asiatica (L.) Lam., Zanthoxylum armatum DC., Zanthoxylum
dimorphophyllum Hemsl. var. spinifolium Rehd.et Wils.
The quality evaluation of Zanthoxylum nitidum root in Chinese Pharmacopoeia has inspection items that are
different from Zanthoxylum nitidum (Roxb.) DC. prodr. var. tomentosum Huang.
The development of standards for the quality and safety control of Zanthoxylum nitidum root can provide a
reference for better development and use of Zanthoxylum nitidum root. Moreover, Zanthoxylum nitidum root
is ranked no. 94 in the priority list of single herbal medicines for developing standards in ISO/TR 23975.
[1]
Thus, it is essential to develop an International Standard for Zanthoxylum nitidum root to ensure the
consistency in the quality of Zanthoxylum nitidum root, which can contribute to the safe use of this herb and
also promote the international trade.
In this document, the identification of commonly adulterated species of Zanthoxylum nitidum root is also
introduced.
As national implementation can differ in different countries, national standards bodies are invited to modify
the values given in 5.8 and 5.10 in their national standards. Examples of national and regional values are
given in Annex C.
v
International Standard ISO 24902:2026(en)
Traditional Chinese medicine — Zanthoxylum nitidum root
1 Scope
This document specifies the minimum requirements and test methods for Zanthoxylum nitidum root.
This document applies to Zanthoxylum nitidum root sold and used as Chinese materia medica (whole
medicinal materials) and decoction pieces derived from this 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 — Dete
...