ISO 19661:2026
(Main)Traditional Chinese medicine — Anemarrhena asphodeloides rhizome
Traditional Chinese medicine — Anemarrhena asphodeloides rhizome
This document specifies the quality and safety requirements for Anemarrhena asphodeloides rhizome. This document applies to Anemarrhena asphodeloides rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.
Médecine traditionnelle chinoise — Rhizome de Anemarrhena asphodeloides
General Information
- Status
- Published
- Publication Date
- 11-Feb-2026
- Technical Committee
- ISO/TC 249 - Traditional Chinese medicine
- Drafting Committee
- ISO/TC 249 - Traditional Chinese medicine
- Current Stage
- 6060 - International Standard published
- Start Date
- 12-Feb-2026
- Due Date
- 06-May-2027
- Completion Date
- 12-Feb-2026
Overview
ISO 19661:2026 - Traditional Chinese medicine - Anemarrhena asphodeloides rhizome sets international quality and safety requirements for the rhizome of Anemarrhena asphodeloides (commonly "Zhimu"), a key herbal ingredient in Traditional Chinese Medicine (TCM). This ISO standard applies to both whole medicinal materials and decoction pieces derived from Anemarrhena asphodeloides and is designed to ensure consistency, safety, and traceability in global trade. It is widely utilized in the export, processing, and regulatory oversight of natural medicines, supporting the harmonization of standards across regions.
Key Topics
Quality and Safety Specifications:
The standard defines strict requirements for the physical, chemical, and safety attributes of Anemarrhena asphodeloides rhizome. These include:- Cleanliness and removal of foreign matter and fibrous roots
- Absence of visible contaminants, insects, or mold
- Morphological and microscopic identification
- Moisture, total ash, and acid-insoluble ash content limits
- Testing for heavy metals (arsenic, mercury, lead, cadmium)
- Limits on pesticide residues
- Marker compound quantification (such as mangiferin)
Standardized Sampling and Testing:
Methods for sampling, macroscopic/microscopic examination, thin-layer chromatography (TLC), and quantitative testing are standardized to ensure reliable results.Packaging, Transportation, and Labelling:
Requirements ensure the rhizome is packaged for protection against light, moisture, contamination, and damage during transit. Labelling must include origin, mass, production/expiry dates, storage methods, and quality details, following global TCM product standards.Test Reporting:
Specific elements for complete and clear test reporting are outlined, supporting full traceability and regulatory compliance.
Applications
International Trade:
ISO 19661:2026 is essential for exporters and importers of Anemarrhena asphodeloides rhizome, enabling compliance with diverse regulatory frameworks and facilitating entry into markets such as Japan, Korea, the EU, and the US.Pharmaceutical Manufacturing:
Used by TCM manufacturers to validate the safety and efficacy of raw materials in patented medicines, Kampo formulas, and herbal decoctions.Inspection and Regulatory Bodies:
Government and quality control labs reference this standard when inspecting batches, setting national norms, or evaluating imports.Product Labelling and Consumer Assurance:
Ensures end-users and healthcare professionals receive clear and traceable information about origin, composition, and safety.
Related Standards
- ISO 18664: Traditional Chinese Medicine - Determination of heavy metals in herbal medicines
- ISO 23723: Traditional Chinese medicine - General requirements for herbal raw material and materia medica
- ISO/TS 21310: Microscopic examination of medicinal herbs
- ISO 21371: Labelling requirements of products intended for oral or topical use
- ISO 22217: Storage requirements for raw materials and decoction pieces
- ISO 22258: Determination of pesticide residues in natural products by gas chromatography
Practical Value
Adopting ISO 19661:2026 helps stakeholders in the TCM supply chain:
- Enhance product quality, safety, and international acceptance
- Reduce risk of contamination and regulatory non-compliance
- Improve efficiency in processing and logistics through unified protocols
- Support market expansion for manufacturers and exporters
ISO 19661:2026 is a cornerstone document for the standardization and globalization of herbal medicines, enabling safe, consistent, and high-quality products that benefit producers, practitioners, and consumers worldwide.
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Frequently Asked Questions
ISO 19661:2026 is a standard published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine — Anemarrhena asphodeloides rhizome". This standard covers: This document specifies the quality and safety requirements for Anemarrhena asphodeloides rhizome. This document applies to Anemarrhena asphodeloides rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.
This document specifies the quality and safety requirements for Anemarrhena asphodeloides rhizome. This document applies to Anemarrhena asphodeloides rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.
ISO 19661:2026 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 19661:2026 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 19661
First edition
Traditional Chinese medicine —
2026-02
Anemarrhena asphodeloides
rhizome
Médecine traditionnelle chinoise — Rhizome de Anemarrhena
asphodeloides
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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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 feature .2
5.3 Microscopic characteristics .3
5.4 Thin-layer chromatogram (TLC) identification .3
5.5 Moisture .3
5.6 Total ash .3
5.7 Acid-insoluble ash .3
5.8 Heavy metals .4
5.9 Pesticide residues .4
5.10 Marker compounds .4
6 Sampling . 4
7 Test method . 4
7.1 Macroscopic identification .4
7.2 Microscopic identification .4
7.3 Thin-layer chromatogram (TLC) identification .4
7.4 Determination of moisture content .4
7.5 Determination of total ash content .4
7.6 Determination of acid-insoluble ash content .4
7.7 Determination of heavy metal contents .4
7.8 Determination of pesticide residues contents.4
7.9 Determination of marker compound .4
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 compound . 7
Annex C (informative) Reference information of national and regional requirements . 9
Bibliography .10
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
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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 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
Anemarrhena asphodeloides rhizome (also known as Anemarrhena Rhizoma, Zhimu in Mandarin) is one of
the commonly used herbal medicines in traditional Chinese medicine (TCM). For instance, of 1607 formulae
in Chinese Pharmacopoeia (2020 edition), 44 contain the Anemarrhena asphodeloides rhizome (accounting
for 2,74 %); among 148 kampo medicines for prescription from the Ministry of Health, Labour, and Welfare
(MHLW) of Japan, 6 formulae contain the Anemarrhena asphodeloides rhizome (accounting for 4,05 %).
[1]
Anemarrhena asphodeloides rhizome was firstly recorded in “Shen Nong Ben Cao Jing” , and has been used
in TCM for a long time for treatment of external contraction of febrile disease, high fever with vexation and
thirst, lung heat and dry cough, bone-steaming and tidal fever, interior heat wasting-thirst, constipation
caused by intestinal dryness. Phytochemical investigations have revealed that Anemarrhena asphodeloides
rhizome contains various chemical constituents, such as xanthones, steroidal saponins, flavones, xylogen,
tannins. Modern pharmacological studies have shown that the xanthones and steroidal saponins are the
main bioactive ingredients in Anemarrhena asphodeloides rhizome, which have the anti-diabetes, anti-
inflammation, anti-tumour, anti-platelet aggregation and anti-thrombotic formation, cardioprotective, and
cognition-enhancing effects.
In the global trade of Anemarrhena asphodeloides rhizome, China is the main export country. Based on the
statistics report of the Department of Market Supervision, Ministry of Commerce of the People's Republic
of China, from 2016 to 2020, the average annual export volume of Anemarrhena asphodeloides rhizome was
758 326,4 kilograms, worth USD 4 068 006. The main destination countries and regions included Japan,
Hong Kong, the Republic of Korea, Taiwan (Province of China), Malaysia, Viet Nam, New Zealand, Germany,
the United States and Thailand.
Anemarrhena asphodeloides rhizome has been recorded in the Pharmacopoeia of the People's Republic of
[2] [3] [4] [5]
China , the European Pharmacopoeia , the Japanese Pharmacopoeia and the Korean Pharmacopoeia ,
and the requirements of each pharmacopoeia are different. The standard of Anemarrhena asphodeloides
rhizome has not been unified at the international level. Therefore, the establishment of an International
Standard is necessary to guarantee the quality, safety, and consistency of the valuable herbal medicine.
As national and regional implementation can differ, national standards bodies are invited to modify the
values given in 5.6 and 5.7 in their national and regional standards. Examples of national and regional values
are given in Annex C.
v
International Standard ISO 19661:2026(en)
Traditional Chinese medicine — Anemarrhena asphodeloides
rhizome
1 Scope
This document specifies the quality and safety requirements for Anemarrhena asphodeloides rhizome.
This document applies to Anemarrhena asphodeloides rhizome that is sold and used as natural medicines
in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces
derived from the plant.
...




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