ISO 24900:2026
(Main)Traditional Chinese medicine — Sophora tonkinensis root and rhizome
- Abstract
This document specifies the minimum requirements and test methods for Sophora tonkinensis root and rhizome. This document applies to Sophora tonkinensis root and rhizome 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 24900:2026 is an International Standard published by ISO for Sophora tonkinensis root and rhizome. It specifies minimum requirements and test methods for this traditional Chinese medicine when it is sold and used as Chinese materia medica and as decoction pieces. It is written for producers, laboratories, distributors, buyers, and inspectors who need a common basis for identification, quality control, storage, and labelling.
What does ISO 24900:2026 specify?
ISO 24900:2026 specifies the quality and test framework for Sophora tonkinensis root and rhizome. The document covers the material itself, how to check it, how to test it, and how to present it in trade.
The main body is organized into:
- Clause 4 - description of the plant material
- Clause 5 - requirements and recommendations
- Clause 6 - sampling
- Clause 7 - test methods
- Clause 8 - test report
- Clause 9 - packaging, storage and transportation
- Clause 10 - marking and labelling
| Annex | What it covers |
|---|---|
| Annex A | TLC identification of Sophora tonkinensis root and rhizome |
| Annex B | HPLC-UV determination of marker compounds |
| Annex C | Reference information for national and regional requirements |
What are the key requirements of ISO 24900:2026?
ISO 24900:2026 sets a practical identity-and-quality scheme. In practice, it asks users to confirm that the material is the correct plant part, free from obvious contamination, and within the chemical and safety limits used for trade and quality control.
Clause 5.1 - general characteristics. The material must be clean, free from leaf material and foreign matter, and free from visible living insects, mouldy fruit, and external contaminants. This matters because the first receiving check can remove obvious defects before lab testing.
Clause 5.2 and 7.1 - macroscopic identification. The document describes the expected appearance, smell, root and rhizome shape, surface features, fracture, and bitterness, and says samples are examined by naked eye in sunlight and by smell. This is the basic check against substitution and adulteration.
Clause 5.3 and 7.2 - microscopic identification. The standard uses microscopic features such as cork, crystal cells, fibre bundles, vessels, and starch-containing parenchyma, with the method taken from ISO/TS 21310. This gives laboratories a more reliable way to confirm botanical identity.
Clause 5.4, 7.3, and Annex A - TLC identification. Thin-layer chromatography [TLC] must show spots matching the reference herbal solution and the mixed reference solution of matrine and oxymatrine. This provides a rapid identity test for routine quality control.
Clauses 5.5 to 5.10 and 7.4 to 7.9 - chemical quality and safety checks. The standard covers moisture, total ash, ethanol-soluble extractives, heavy metals, pesticide residues, and marker compounds. In practice, these tests show whether the material is suitably dried, reasonably pure, and controlled for contamination and chemical consistency.
Clause 5.10 and Annex B - marker compounds. The marker compounds are matrine and oxymatrine, and the annex gives a high-performance liquid chromatography with ultraviolet detection [HPLC-UV] procedure for measuring them. This is the main chemical content check used to compare batches.
Clauses 6, 8, 9, and 10 - handling and documentation. Sampling follows ISO 23723:2021, test reports must record identification, sampling, method, results, and anomalies, and the product must be packaged, stored, transported, marked, and labelled in controlled conditions. This supports traceability from sample to shipment.
What terms does ISO 24900:2026 define?
- Sophora tonkinensis root and rhizome - The dried root and rhizome of Sophora tonkinensis Gagnep. (Fam. Leguminosae).
- Marker compound - In this document, matrine and oxymatrine are the marker compounds used for chemical control.
- Chinese materia medica - The whole medicinal material as sold and used in traditional Chinese medicine practice.
- Decoction piece - A processed form derived from the plant material for decoction use.
- TLC - Thin-layer chromatography, used here for identity confirmation by spot comparison.
- HPLC-UV - High-performance liquid chromatography with ultraviolet detection, used in Annex B to measure marker compounds.
- CRS - Chemical Reference Substance, the reference material used to prepare comparison solutions.
Who uses ISO 24900:2026?
ISO 24900:2026 is used by growers, collectors, processors, manufacturers, testing laboratories, and quality control teams working with traditional Chinese medicine materials. It is also relevant to buyers, distributors, and regulators who need to verify identity, check contamination, review lab reports, and confirm packaging and labelling before release or sale.
Which standards are used with ISO 24900:2026?
- ISO 18664 - provides the method for determining heavy metals in herbal medicines.
- ISO/TS 21310 - provides the microscopic examination method used for identification.
- ISO 21371 - provides labelling requirements for products intended for oral or topical use.
- ISO 22217:2020 - provides storage requirements for raw materials and decoction pieces.
- ISO 22258 - provides the method for determining pesticide residues by gas chromatography.
- ISO 23723:2021 - provides general requirements for herbal raw material and materia medica, and is also used for sampling and for several test methods.
What does the ISO 24900:2026 document contain?
ISO 24900:2026 contains a plant description, an illustrated morphological description, and a microscopic description that support identification. It also includes a TLC method in Annex A and an HPLC-UV method in Annex B, each with sample preparation and comparison with reference materials.
The body of the document also gives the test-report items, packaging and storage rules, and marking and labelling items to record on packages. Annex C adds comparative reference information from national and regional requirements, which is useful when aligning local specifications with the ISO framework.
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Frequently Asked Questions
ISO 24900:2026 is a standard published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine — Sophora tonkinensis root and rhizome". This standard covers: This document specifies the minimum requirements and test methods for Sophora tonkinensis root and rhizome. This document applies to Sophora tonkinensis root and rhizome 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 Sophora tonkinensis root and rhizome. This document applies to Sophora tonkinensis root and rhizome sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
ISO 24900:2026 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 24900:2026 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 24900
First edition
Traditional Chinese medicine —
2026-08
Sophora tonkinensis root and
rhizome
Médecine traditionnelle chinoise — Racine et rhizome de
Sophora tonkinensis
Reference number
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . . 2
5 Requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological features of root and rhizome .3
5.3 Microscopic identification .3
5.4 Thin-layer chromatogram (TLC) identification .3
5.5 Moisture .3
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 Determination of ethanol-soluble extractives .4
7.7 Determination of heavy metals .4
7.8 Determination of pesticide residues .5
7.9 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 for national and regional requirements .10
Bibliography .13
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,
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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)
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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
Sophora tonkinensis root and rhizome (the Chinese Pinyin name: Shandougen) is the dried root and rhizome
of Sophora tonkinensis Gagnep. (Fam. Leguminosae). It is mainly produced in southwest China and Vietnam,
belongs to one of the toxic traditional Chinese medicines. Sophora tonkinensis root and rhizome is first
[1]
recorded in "Kaibao Bencao" in the Song Dynasty, and called "solution throat swelling first medicine" in
[2]
"Becao Qiuzhen" in the Qing Dynasty .
Sophora tonkinensis root and rhizome can clear heat and detoxify, reduce swelling and enhance pharynx.
It demonstrates anti-tumour, anti-inflammation, anti-oxidation, antibacterial and immunity-enhancing
effects. It is often used in the clinical treatment of pharyngitis and tonsillitis, and its preparations are also
used in the treatment of chronic hepatitis and liver cancer as adjuvant therapy.
More than 200 compounds have been identified from the Sophora tonkinensis root and rhizome, mainly
include alkaloids, flavonoids, triterpenoids, triterpenoid saponins, and polysaccharides, where alkaloids
both serve as the important material basis for the pharmacodynamic action and the main substances causing
toxicity. The adverse events induced by Sophora tonkinensis root and rhizome and its alkaloids include nerve
injury, hepatic injury, cardiovascular injury, kidney injury and reproductive injury, and gastrointestinal
reaction. Quinolizidine alkaloids are the main toxic components, mainly including matrine, oxymatrine,
cytisine, sophocarpine, oxysophocarpine, sophoridine, sophoramine, and lehmannine. The mechanism of
toxicity needs further study. Because of the coexisting of its efficacy and poison, long-term or high-dose
administration often leads to a series of safety problems in the clinical application process.
At present, the quality of Sophora tonkinensis root and rhizome varies greatly. It is mainly represented by
the substitution of other varieties in medicine, such as Menispermun dauricum, Indigofera fortunei, Mogjanin
philippinensis. There are also the above-ground parts (non-medicinal parts) adulterated with Sophora
tonkinensis sold as Sophora tonkinensis root and rhizome.
Moreover, Sophora tonkinensis root and rhizome is ranked no. 54 in the priority list of single herbal medicines
[3]
for developing standards in ISO/TR 23975. Therefore, it is necessary to standardize the quality and safety
control of Sophora tonkinensis root and rhizome, so as to provide reference for studying the toxicity of
Sophora tonkinensis root and rhizome.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.6 and 5.10 in their national standards. Examples of national and regional values are given in Annex C.
v
International Standard ISO 24900:2026(en)
Traditional Chinese medicine — Sophora tonkinensis root and
rhizome
1 Scope
This document specifies the minimum requirements and test methods for Sophora tonkinensis root and
rhizome.
This document applies to Sophora tonkinensis root and rhizome 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 — 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 22217:2020, 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 23723:2021, 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
Sophora tonkinensis root and rhizome
dried root and rhizome of Sophora tonkinensis Gagnep. (Fam. Leguminosae)
3.2
marker compo
...