ISO 24902:2026
(Main)Traditional Chinese medicine — Zanthoxylum nitidum root
General Information
- 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
Overview
ISO 24902: Traditional Chinese Medicine - Zanthoxylum nitidum Root specifies the minimum quality requirements and test methods for the dried root of Zanthoxylum nitidum (Roxb.) DC., commonly known as Liang-Mian-Zhen. This standard applies to Zanthoxylum nitidum root in the form of Chinese materia medica (whole medicinal material) and decoction pieces sold and used in traditional Chinese medicine (TCM) practices globally.
Aimed at promoting safety, quality consistency, and international trade of TCM herbal products, ISO 24902 addresses challenges such as identification, adulteration, and regional quality variations of Zanthoxylum nitidum root in the marketplace.
Key Topics
Scope and Definitions
Defines Zanthoxylum nitidum root and marker compounds relevant for quality evaluation.Identification and Purity Requirements
- Macroscopic and microscopic characteristics
- Thin-layer chromatogram (TLC) identification
- TLC and HPLC-UV methods for marker compounds (e.g., nitidine chloride)
Quality Control Specifications
- Assessment of moisture, total ash, and ethanol-soluble extractives
- Limits and test methods for heavy metals and pesticide residues
Contamination and Safety
- Adulteration prevention (distinguishing genuine root from common forgeries)
- Packaging, storage, and transport requirements to maintain quality and minimize contamination
Marking and Labelling
- Labelling for origin, production/expiry dates, weight, and storage
Regional Adaptability
- Flexibility for national or regional values in moisture, extractives, and marker compound content
Applications
ISO 24902 is a key document for multiple stakeholder groups in the supply chain of traditional Chinese medicinal products:
Herbal Material Suppliers and Manufacturers
Ensures botanically and chemically consistent Zanthoxylum nitidum root preparations, reducing the risk of adulteration and safety issues.Quality Control Laboratories
Standardizes test methods for identity (macroscopic, microscopic, TLC, HPLC), purity, and contaminants, facilitating reliable comparison and compliance reporting.Regulatory Authorities and Inspectors
Offers a harmonized reference for safety and quality compliance in both domestic and international trade, including requirements for heavy metals, pesticides, and proper labelling.Healthcare Practitioners and Pharmacies
Provides assurance of consistent medicinal quality, reducing variability in clinical use and patient outcomes.Exporters and Importers
Supports international trade of Zanthoxylum nitidum root by harmonizing quality expectations across markets such as China, Japan, Southeast Asia, and beyond.
Related Standards
Implementation of ISO 24902 aligns with several other ISO standards for traditional Chinese medicine (TCM) and herbal products, ensuring an integrated approach to quality:
- ISO 18664 – Determination of heavy metals in TCM herbal medicines
- ISO/TS 21310 – Microscopic examination of medicinal herbs
- ISO 21371 – Labelling requirements of products intended for oral or topical use
- ISO 22217:2020 – Storage requirements for raw materials and decoction pieces
- ISO 22258 – Determination of pesticide residues in natural products by gas chromatography
- ISO 23723:2021 – General requirements for herbal raw material and materia medica
- ISO/TR 23975 – Priority list of single herbal medicines for developing standards
Adhering to these standards strengthens the credibility, safety, and traceability of traditional Chinese medicinal products in the global market.
Keywords: ISO 24902, Zanthoxylum nitidum root, Liang-Mian-Zhen, traditional Chinese medicine, TCM, herbal quality standards, test methods, materia medica, TLC, HPLC-UV, heavy metals, pesticide residues, international trade, medicinal plant safety, labelling requirements
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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
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or ISO’s member body in the country of the requester.
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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 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
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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)
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rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
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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
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