ISO 25657:2026
(Main)Traditional Chinese medicine — Curculigo orchioides rhizome
- Abstract
This document specifies the quality and safety requirements and test methods for the Curculigo orchioides rhizome, which is derived from the dried rhizome of Curculigo orchioides Gaertn. (Fam. Amaryllidaceae). This document is applicable to Curculigo orchioides rhizomes that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Status
- Published
- Publication Date
- 11-Oct-2026
- Technical Committee
- ISO/TC 249 - Traditional Chinese medicine
- Current Stage
- 6060 - International Standard published
- Start Date
- 12-Oct-2026
- Completion Date
- 12-Oct-2026
ISO 25657:2026 is an International Standard from ISO for the traditional medicine raw material Curculigo orchioides rhizome. It specifies quality and safety requirements, test methods, packaging, marking and labelling for the dried rhizome of Curculigo orchioides Gaertn. for use and trade as a natural medicine. The document is aimed at people who need to identify, test, buy, sell, or release Curculigo orchioides rhizome in international trade.
What does ISO 25657:2026 specify?
ISO 25657:2026 specifies the quality and safety requirements for Curculigo orchioides rhizome and the methods used to check them. It applies to the dried rhizome itself, including Chinese materia medica and decoction pieces derived from this plant.
The document is organized into clauses 1 to 10, covering scope, normative references, terms and definitions, descriptions, requirements and recommendations, sampling, test methods, test report, packaging and storage, and marking and labelling. It also has four informative annexes that give identification and assay detail and compare values used in other standards.
| Annex | What it covers |
|---|---|
| Annex A | Thin-layer chromatogram (TLC) identification |
| Annex B | Determination of the curculigoside content |
| Annex C | Determination of the orcinol glucoside content |
| Annex D | Reference values of Curculigo orchioides rhizome in different national and regional standards |
What are the key requirements of ISO 25657:2026?
ISO 25657:2026 combines botanical identity checks, chemical tests, and contamination limits so batches can be judged consistently. In practice, this means a batch is not only checked for the right plant origin, but also for visible quality, marker compounds, heavy metals, and pesticide residues.
General condition and appearance
Clause 5.1 requires the rhizome to be clean, free from leaves, stem, and foreign matter, and free from living insects, mouldy material, and visible external contaminants. For buyers and inspectors, this is the first acceptance gate before lab testing starts.
Clause 5.2 describes the expected appearance, colour, size, texture, odour, and taste. The rhizome is cylindrical and slightly curved, with a brownish rough surface, rootlet scars, transverse wrinkles, and a slight odour with a slightly bitter, astringent taste. These points help spot substitution or poor grading during incoming inspection.
Microscopic identity
Clause 5.3 gives the microscopical characteristics of the transverse section and powder. It describes cork, cortex, calcium oxalate crystals, mucilage cells, starch grains, and spiral vessels, which are the features used to confirm the plant material under the microscope.
This matters because microscopic examination can detect a wrong species, over-processing, or mixing with other materials even when the sample looks acceptable by eye.
Physical and extractive limits
Clause 5.4 limits moisture content to not more than 13.0%, and Clause 5.5 limits total ash to not more than 10.0%. Clause 5.6 sets a minimum for ethanol-soluble extractives at not less than 7.0%.
In practice, moisture limit helps control storage stability, ash indicates inorganic contamination or excessive dirt, and extractives give a simple measure of the material’s soluble content and batch strength.
TLC identification and marker compounds
Clause 5.7 requires TLC identification to show the spot or band with the same colour and position as the reference solution. Clause 5.8 names marker compounds such as curculigoside and orcinol glucoside for determination.
This gives laboratories a fast identity check and a way to compare batches using chemical markers rather than appearance alone.
Heavy metals and pesticide residues
Clause 5.9 requires determination of heavy metals such as arsenic, mercury, lead, and cadmium. Clause 5.10 requires determination of pesticide residues such as DDT, endrin, BHC, aldrin, and dieldrin.
These limits matter because the standard is meant for medicinal use, where contamination control is part of product safety and market access.
Sampling, reporting, and handling
Clause 6 points sampling of raw and processed rhizomes to ISO 23723:2021. Clause 8 requires the test report to identify the sample, cite the standard, state the sampling and test methods, give results, note operating details and anomalies, and record the test date.
Clauses 9 and 10 cover packaging, storage, transportation, and labelling. They require packaging that does not taint or damage the product, storage in line with ISO 22217, protection from light, moisture, pollution, and foreign substances, and marking of quality features, mass, origin, production and expiry dates, storage method, and destination-country requirements.
What terms does ISO 25657:2026 define?
- Curculigo orchioides rhizome - the dried rhizome of Curculigo orchioides Gaertn. (Fam. Amaryllidaceae), which is the material covered by the standard.
- Thin-layer chromatography (TLC) - an identification method used to compare the sample with reference materials by colour and spot position on a TLC plate.
- High-performance liquid chromatography (HPLC) - the analytical method used in Annex B and Annex C to determine marker compound content.
- Chemical reference substance (CRS) - a reference material used in Annex A to prepare the TLC reference solution.
- Curculigoside - one of the marker compounds named in the standard and used in the HPLC assay annex.
- Orcinol glucoside - another marker compound named in the standard and used in the HPLC assay annex.
Who uses ISO 25657:2026?
ISO 25657:2026 is used by producers and processors of Curculigo orchioides rhizome, quality control laboratories, importers and exporters, and buyers in the natural medicine supply chain. It is also relevant to inspectors and regulatory staff who need to verify identity, contamination limits, packaging, and labelling for international trade.
The standard is especially relevant where Curculigo orchioides rhizome is sold as Chinese materia medica or as decoction pieces. It gives a common basis for batch acceptance, laboratory testing, and specification setting across different markets.
Which standards are used with ISO 25657:2026?
ISO 25657:2026 names several standards that support its tests and handling requirements:
- ISO 23723:2021 - provides general requirements for herbal raw material and materia medica, and is used for sampling and some analytical methods.
- ISO/TS 21310 - provides microscopic examination of medicinal herbs, used for the microscopy test.
- ISO 18664 - provides the method for determining heavy metals in herbal medicines used in Traditional Chinese Medicine.
- ISO 22258 - provides the gas chromatography method for determining pesticide residues in natural products.
- ISO 22217 - provides storage requirements for raw materials and decoction pieces, used for storage control.
- ISO 2131721371 - is the labelling requirements document cited for package marking and labelling.
What does the ISO 25657:2026 document contain?
ISO 25657:2026 contains a botanical description, a figure of the plant and rhizome structure, detailed visual and microscopic descriptors, and limits for moisture, ash, extractives, TLC identity, marker compounds, heavy metals, and pesticide residues. It also gives the sampling rule, the test methods to use for each check, and the required elements of the test report.
The informative annexes add practical laboratory detail. Annex A sets out a TLC procedure with test solution, reference drug solution, reference substance solution, plate conditions, mobile phase, spray reagent, and a typical chromatogram. Annex B and Annex C give HPLC procedures, reference solutions, sample preparation, chromatography conditions, formulas, and example chromatograms for curculigoside and orcinol glucoside.
Annex D provides a comparison of values used in different national and regional standards. That helps readers see how ISO 25657:2026 relates to other existing specifications for the same herbal material.
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 25657:2026 is a standard published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine — Curculigo orchioides rhizome". This standard covers: This document specifies the quality and safety requirements and test methods for the Curculigo orchioides rhizome, which is derived from the dried rhizome of Curculigo orchioides Gaertn. (Fam. Amaryllidaceae). This document is applicable to Curculigo orchioides rhizomes that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
This document specifies the quality and safety requirements and test methods for the Curculigo orchioides rhizome, which is derived from the dried rhizome of Curculigo orchioides Gaertn. (Fam. Amaryllidaceae). This document is applicable to Curculigo orchioides rhizomes that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
ISO 25657:2026 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 25657:2026 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 25657
First edition
Traditional Chinese medicine —
2026-10
Curculigo orchioides rhizome
Médecine traditionnelle chinoise — Rhizome de Curculigo
orchioides
Reference number
© ISO 2026
All rights reserved.
This ISO publication is protected by copyright and is owned by ISO and/or its licensors.
The content of this ISO publication is provided under licence, not sold. Use is subject to the applicable licence terms issued by ISO,
an ISO member body, or an authorized third-party distributor.
Except as required for implementation or expressly permitted by a separate licence, no part of this ISO publication may be
reproduced, distributed, modified, used, or made available in any form or by any means – electronic or mechanical, including
photocopying, scanning, recording, or posting on internal or external digital platforms.
Any use beyond the scope of the granted rights is prohibited and may result in legal action.
ISO copyright office
CP 401 • 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 Descriptions . 1
5 Requirements and recommendations . 2
5.1 General .2
5.2 Morphological features .2
5.2.1 Appearance .2
5.2.2 Colour .3
5.2.3 Dimensions .3
5.2.4 Texture .3
5.2.5 Odour and taste .3
5.3 Microscopical characteristics .3
5.4 Moisture .4
5.5 Total ash .4
5.6 Ethanol-soluble extractives .4
5.7 Thin-layer chromatogram (TLC) identification .4
5.8 Marker compound(s) .5
5.9 Heavy metals .5
5.10 Pesticide residues .5
6 Sampling . 5
7 Test method . 5
7.1 Macroscopic identification .5
7.2 Microscopical identification .5
7.3 Determination of the moisture content .5
7.4 Determination of the total ash content .5
7.5 Water-soluble extractives .5
7.6 Thin-layer chromatogram (TLC) identification .5
7.7 Determination of marker compound(s).5
7.8 Determination of heavy metals contents .5
7.9 Determination of pesticide residues contents.5
8 Test report . 6
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Thin-layer chromatogram (TLC) identification . 7
Annex B (informative) Determination of the curculigoside content . 9
Annex C (informative) Determination of the orcinol glucoside content .11
Annex D (informative) Reference values of the Curculigo orchioides rhizome in different
national and regional standards .13
Bibliography . 14
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 Curculigo orchioides rhizome is the dried rhizome of Curculigo orchioides Gaertn. (Fam. Amaryllidaceae),
which is known as Xian Mao (仙茅) in Chinese pinyin, Curculiginis, Kali Musli available in international
markets, which has a long history of medicinal use and a wide range of clinical applications in China,
Japan, Korea, Vietnam, Myanmar, India and other East Asian countries. The Curculigo orchioides rhizome is
considered to have attributes beneficial to the kidney and liver channels, and it is traditionally valued and
reported for treating impotence, limb limpness, arthritis of the lumbar and knee joints and watery diarrhea.
The Curculigo orchioides rhizome has a complex chemical composition, including various constituents
such as phenols and phenolic glucosides, norlignans, terpenoids, alkaloids and flavones. Modern
pharmacological studies have reported that phenols and phenolic glucosides, norlignans and terpenoids are
the main active constituents in the Curculigo orchioides rhizome for enhancing adaptive effects, increasing
immunomodulation, having anti-oxidant, anti-osteoporosis, hepatoprotective, oestrogenic activities and
effects on sexual behaviour.
In global trade, based on Chinese customs data, there is a relatively large demand for Curculigo orchioides
rhizomes in the Chinese Materia Medica market at home and abroad. Between 2017 and 2022, 200 to 300
tons of Curculigo orchioides rhizome have been exported to Japan, Korea, Hongkong of China and other
countries and regions every year. In addition, between 2017 and 2022, 1 000 tons of Curculigo orchioides
rhizomes have been imported from Myanmar and Vietnam every year.
As a globally used herbal medicine, the Curculigo orchioides rhizome has been widely used in polyherbal
formulations of Traditional Chinese, Kampo and Indian medicines. It has also been included in the
[1]
pharmacopoeia of many countries and regions, such as the Chinese Pharmacopoeia (2025 edition) ,
th [2]
the Korean Herbal Pharmacopoeia (4 edition) , the Hong Kong Chinese Materia Medica Standards (Volume
[3] [4]
4) and the Ayurveda Pharmacopeia of India (Part I, Volume 4) . However, specifications and quality
requirements in these standards are not unified due to the lack of an International Standard for the Curculigo
orchioides rhizome.
Additionally, the quality of the Curculigo orchioides rhizome provided from different areas varies a lot.
The Curculigo orchioides rhizome is ranked as a relatively high priority in the priority list of single herbal
[5]
medicines for developing standards, as defined in ISO/TR 23975:2025 . Thus, there is a clear and urgent
need to develop an International Standard for harmonizing these existing standards, as well as ensuring the
safety and effectiveness of the Curculigo orchioides rhizome.
As national implementations can differ, national standards bodies can modify the values given in 5.4, 5.5
and 5.6 to adapt to their national standards. Examples of national and regional values are given in Annex D.
v
International Standard ISO 25657:2026(en)
Traditional Chinese medicine — Curculigo orchioides rhizome
1 Scope
This document specifies the quality and safety requirements and test methods for the Curculigo
orchioides rhizome, which is derived from the dried rhizome of Curculigo orchioides Gaertn. (Fam.
Amaryllidaceae).
This document is applicable to Curculigo orchioides rhizomes that are sold and used as natural medicines
in international trade, including 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, 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 foll
...