ISO 22212:2025

Traditional Chinese medicine - Gastrodia elata tuber

This document specifies minimum requirements and test methods for Gastrodia elata tuber that is derived from cultivated and artificially propagated Gastrodia elata Bl. It is applicable to Gastrodia elata tuber that is sold and used as Chinese materia medica, specifically excluding the wild forms of the species.

Médecine traditionnelle chinoise — Tubercule de Gastrodia elata

General Information

• Status: Published
• Publication Date: 17-Dec-2025
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 1 - Quality and safety of raw materials and traditional processing
• Current Stage: 6060 - International Standard published
• Start Date: 18-Dec-2025
• Due Date: 05-Aug-2026
• Completion Date: 18-Dec-2025

Relations

• Revises: ISO 22212:2019 - Traditional Chinese medicine - Gastrodia elata tuber
• Effective Date: 08-Feb-2025

Overview - ISO 22212:2025 for Gastrodia elata tuber

ISO 22212:2025 is the International Standard that defines minimum requirements and test methods for Gastrodia elata tuber used as Chinese materia medica. It applies specifically to tubers derived from cultivated and artificially propagated Gastrodia elata Bl., and explicitly excludes wild forms. The document covers quality, identification and safety parameters to support consistent clinical effectiveness and safe international trade.

Key topics and technical requirements

The standard specifies descriptive, compositional and analytical requirements, including:

• Morphology and physical characteristics: tuber size, shape, colour, texture and typical anatomical features (buds, latent buds, longitudinal wrinkles).
• Quality limits:
  • Moisture: mass fraction ≤ 16.0%
  • Total ash: mass fraction ≤ 6.0%
  • Dilute ethanol‑soluble extract: mass fraction ≥ 14.0%
  • Marker compounds: sum of gastrodin and p‑hydroxybenzyl alcohol ≥ 0.20%
• Identification: marker compounds (gastrodin, p‑hydroxybenzyl alcohol) identified by thin‑layer chromatography (TLC) showing specific spots/bands.
• Contaminants and residues:
  • Determination of heavy metals (arsenic, mercury, lead, cadmium)
  • Determination of pesticide residues (including Benzex, dichlorodiphenyltrichloroethane (DDT) and quintozene)
  • Sulfur dioxide content
• Sampling and test methods:
  • Sampling follows ISO 23723 (sample batch definitions, max batch size noted)
  • Macroscopic identification requires random samples (≥ 500 g) for visual, smell and taste inspection
  • Detailed test procedures and informative annexes (A–F) cover moisture, ethanol‑soluble extract, TLC identification and quantification of markers.

Practical applications and users

ISO 22212:2025 is intended for:

• Manufacturers and cultivators of Gastrodia elata tuber for quality control and product specification
• Analytical and contract laboratories performing routine testing (moisture, ash, marker assays, contaminants)
• Regulatory authorities, customs and standards bodies assessing safety and conformity for trade
• Pharmacopoeia committees and Traditional Chinese Medicine (TCM) product developers seeking harmonized test methods and acceptance criteria
• Traders, distributors and buyers who require verified quality for clinical use or manufacturing

Related standards

Normative references used for methods and limits include:

• ISO 23723 - general requirements for herbal raw material and materia medica
• ISO 18664 - heavy metals determination
• ISO 22258 - pesticide residues by GC
• ISO 22590 - sulfur dioxide determination
• ISO 21371 - labelling requirements

ISO 22212:2025 supports consistent, safe and traceable use of Gastrodia elata tuber across international markets and laboratory workflows.

Standards Content (Sample)

International
Standard
ISO 22212
Second edition
Traditional Chinese medicine —
2025-12
Gastrodia elata tuber
Médecine traditionnelle chinoise — Tubercule de Gastrodia elata
Reference number
© ISO 2025
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements and recommendations . 4
5.1 General characteristics .4
5.2 Morphological features .4
5.3 Moisture .4
5.4 Total ash .4
5.5 Dilute ethanol-soluble extract .4
5.6 Identification of marker compound(s).4
5.7 Marker compound(s) .4
5.8 Heavy metals .4
5.9 Pesticide residues .5
5.10 Sulfur dioxide . .5
6 Sampling . 5
7 Test methods . 5
7.1 Macroscopic identification .5
7.2 Determination of moisture .5
7.3 Determination of total ash .5
7.4 Determination of dilute ethanol-soluble extract .5
7.5 Identification of marker compound(s).5
7.6 Determination of marker compound(s).5
7.7 Determination of heavy metals .5
7.8 Determination of pesticide residues .5
7.9 Determination of sulfur dioxide .5
8 Test report . 6
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Determination of moisture . 7
Annex B (informative) Determination of dilute ethanol-soluble extract . 8
Annex C (informative) Identification of gastrodin . 9
Annex D (informative) Identification of p-hydroxybenzyl alcohol .11
Annex E (informative) Determination of gastrodin and p-hydroxybenzyl alcohol.13
Annex F (informative) Reference values of national and regional limits in Gastrodia elata tuber .16
Bibliography . 17

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 documents 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 may not represent the latest information, which may be obtained from the patent database available at
http://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.
This second edition cancels and replaces the first edition (ISO 22212:2019), which has been technically
revised.
The main changes are as follows:
— 5.3: change of "15,0 %" to "16,0 %";
— 5.4: change of "4,5 %" to "6,0 %";
— 5.5: change of "15,0 %" to "14,0 %";
— 5.6 correction of "brands" to "bands", replacement of "obtained from the test and reference solutions in
the same position with the same colour" with "specific to these compounds";
— 5.9: change of “shall” to “should”;
— 5.10: change of “shall” to “should”;
— 7.3: replacement of “ISO 1575” with “ISO 23723”;
— 7.8: replacement of "CAC/MRL01-2009 and CODEX STAN 229-1993, REV.1-2003" with "ISO 22258";
— 7.9: replacement of “ISO 5379” with “ISO 22590”;
— Table F.1: update of Chinese Pharmacopoeia to 2020 edition, update of Korean Pharmacopoeia to the
12th edition;
— Bibliography: update of Chinese Pharmacopoeia to 2020 edition, update of Korean Pharmacopoeia to the
12th edition.
iv
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.

v
Introduction
Gastrodia elata tuber is a medicinal herb which has been used as an anticonvulsant, analgesic and sedative
to treat general paralysis, epilepsy, tetanus and vertigo in Asian countries for thousands of years.
There are at least 16 countries and regions using Gastrodia elata tuber and its products. Major users
include China, Japan, the republic of Korea, the United State, Australia, Austria and Singapore. Due to its
great demand and high price in the global market, trade in Gastrodia elata tuber has been complicated by
adulteration, substitution and species identification issues. The toxic roots of other species, such as the
plants of the Phytolaccaceae family, are sometimes misused as Gastrodia elata tuber, which can cause health
risks. Factors including contamination, packaging and storage conditions also affect the quality of Gastrodia
elata tuber.
The establishment of an International Standard for Gastrodia elata tuber is therefore necessary to support
its quality consistency, clinical effectiveness and safety in international trade.
As national implementation can differ, national standards bodies are invited to modify the values given
in 5.3, 5.4, 5.5 and 5.7 in their national standards. Examples of national and regional values are given in
Annex F.
vi
International Standard ISO 22212:2025(en)
Traditional Chinese medicine — Gastrodia elata tuber
1 Scope
This document specifies minimum requirements and test methods for Gastrodia elata tuber that is derived
from cultivated and artificially propagated Gastrodia elata Bl.
It is applicable to Gastrodia elata tuber that is sold and used as Chinese materia medica, specifically excluding
the wild forms of the species.
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 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration
ISO 23723, Traditional Chinese medicine — General requirements for herbal raw material and materia medica
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use
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
tuber
short fleshy usually underground stem bearing minute scale leaves each of which bears a bud in its axil and
is potentially able to produce a new plant
3.2
Gastrodia elata tuber
dried tuber (3.1) of Gastrodia elata Bl. (Orchidaceae) after it has been steamed or boiled thoroughly
3.3
bud
undeveloped or embryonic shoot in red-brown to dark brown, which is parrot-beak-shaped and grows on
the apex of the tuber (3.1)
Note 1 to entry: See Figure 1.

3.4
latent bud
bud (3.3) which remains undeveloped or dormant, arranged along the body of Gastrodia elata tuber (3.2)
Note 1 to entry: See Figure 1.
3.5
sample
portion taken from the sample batch (3.6) during one single sampling action
3.6
s
...