ISO 13615:2024

Traditional Chinese medicine - Atractylodes macrocephala rhizome

This document specifies requirements and test methods for Atractylodes macrocephala rhizome that is derived from Atractylodes macrocephala Koidz. It is applicable to Atractylodes macrocephala rhizome that is sold and used as a natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.

Médecine traditionnelle chinoise — Rhizome d'Atractylodes macrocephala

General Information

• Status: Published
• Publication Date: 25-Jul-2024
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 6060 - International Standard published
• Start Date: 26-Jul-2024
• Due Date: 01-Apr-2025
• Completion Date: 26-Jul-2024

Overview

ISO 13615:2024 - Traditional Chinese medicine - Atractylodes macrocephala rhizome establishes international quality, safety and testing requirements for the dried rhizome of Atractylodes macrocephala Koidz. It applies to whole medicinal materials and decoction pieces traded or used as natural medicine in international commerce. The standard harmonizes identification, sampling, analytical methods and handling to support safe, consistent supply and regulatory compliance for this widely used TCM herb.

Key topics and technical requirements

• Identification and description
  • Macroscopic features (shape, size: about 3–13 cm long and 1.5–7 cm diameter, colour, fracture, oil cavities) and characteristics of decoction pieces are specified for visual inspection.
  • TLC identification is required; HPLC identification (atractylenolide II, atractylenolide III and atractylon peaks) is used when TLC is inconclusive. Annex A and B give method guidance.
• Quality limits
  • Moisture ≤ 15.0%
  • Total ash ≤ 7.0%
  • Presence and levels of sulfur dioxide residues, ethanol‑soluble extractives and essential oil content must be determined.
• Contaminant testing
  • Determination of heavy metals (arsenic, cadmium, lead, mercury) and pesticide residues (e.g., BHC, DDT, quintozene) is required.
• Sampling and test methods
  • Sampling follows ISO 23723; many test procedures reference ISO standards for heavy metals, pesticides, sulfur dioxide and moisture/ash determinations.
• Supply chain controls
  • The standard includes requirements for sampling, test reporting, packaging, storage, transportation, marking and labelling to ensure product integrity in trade.

Applications and users

ISO 13615:2024 is practical for:

• Herbal manufacturers and processors producing Atractylodes macrocephala rhizome or decoction pieces.
• Quality control and analytical laboratories performing TLC, HPLC and contaminant testing.
• Exporters, importers and distributors ensuring compliance with international TCM quality and safety expectations.
• Regulatory authorities and purchasers seeking harmonized specifications for market surveillance and procurement.
• Farmers and value‑chain stakeholders aiming to meet export and pharmacopoeial requirements.

Practical benefits include harmonized testing protocols, clearer acceptance criteria for moisture and ash, and defined contaminant testing to reduce trade barriers and improve consumer safety for TCM products.

Related standards

Normative references used by ISO 13615:2024 include:

• ISO 23723 (general requirements and sampling)
• ISO 18664 (heavy metals)
• ISO 22258 (pesticide residues)
• ISO 22590 (sulfur dioxide)
• ISO 21371 (labelling)
• ISO 22217 (storage)

Keywords: ISO 13615:2024, Atractylodes macrocephala rhizome, traditional Chinese medicine, TCM quality standard, TLC identification, HPLC, moisture content, heavy metals, pesticide residues, decoction pieces.

Standards Content (Sample)

International
Standard
ISO 13615
First edition
Traditional Chinese medicine —
2024-07
Atractylodes macrocephala rhizome
Médecine traditionnelle chinoise — Rhizome d'Atractylodes
macrocephala
Reference number
© ISO 2024
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
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Phone: [phone]
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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 . 2
5 Quality and safety requirements and recommendations . 3
5.1 General characteristics .3
5.2 Morphological features .3
5.2.1 Atractylodes macrocephala rhizome .3
5.2.2 Decoction pieces .3
5.3 Identification .3
5.3.1 Thin-layer chromatography (TLC) identification .3
5.3.2 High performance liquid chromatography (HPLC) identification .3
5.4 Moisture .3
5.5 Total ash .4
5.6 Sulfur dioxide residues . . .4
5.7 Ethanol-soluble extractives .4
5.8 Essential oil.4
5.9 Heavy metals .4
5.10 Pesticide residues .4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification .4
7.2 Thin-layer chromatography (TLC) identification .4
7.3 High performance liquid chromatography (HPLC) identification.4
7.4 Determination of moisture content .4
7.5 Determination of total ash content .4
7.6 Determination of sulfur dioxide residues content .4
7.7 Determination of ethanol-soluble extractives content .5
7.8 Determination of essential oil content .5
7.9 Determination of heavy metals content .5
7.10 Determination of pesticide residues content .5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatography (TLC) identification . 6
Annex B (informative) High performance liquid chromatography (HPLC) identification . 8
Annex C (informative) Reference values of national and regional limits .11
Bibliography .12

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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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)
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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 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
Atractylodes macrocephala rhizome, the dried rhizome of Atractylodes macrocephala Koidz., is a widely
used herbal medicine in China and many other countries. In traditional Chinese medicine, this herb can
tonify the Spleen-Qi, and is used to treat distension in the abdomen, loose stools, and diarrhoea. Modern
pharmacological studies also demonstrate its great potential in immuno-enhancement and indigestion
treatment. The market, yield, and trade volume of Atractylodes macrocephala rhizome are large and develop
rapidly in recent years.
Atractylodes macrocephala rhizome has been recorded in several pharmacopoeias, including Chinese
[1] [2] [3] [4]
Pharmacopoeia , European Pharmacopoeia , Korean Pharmacopoeia , Japanese Pharmacopoeia and
[5]
Hong Kong Chinese Materia Medical Standards . The requirements and specifications in these standards
have differences. Therefore, it is important to develop an International Standard for harmonizing the
existing standards, as well as ensuring the safety and effectiveness of Atractylodes macrocephala rhizome,
which can benefit farmers, consumers, enterprises and governments involved in the cultivation, regulation
and trade of Atractylodes macrocephala rhizome.
As national implementation may differ, national standards bodies are invited to modify the values given in
5.4 and 5.5 in their national standards. Examples of national and regional values are given in Annex C.

v
International Standard ISO 13615:2024(en)
Traditional Chinese medicine — Atractylodes
macrocephala rhizome
1 Scope
This document specifies requirements and test methods for Atractylodes macrocephala rhizome that is
derived from Atractylodes macrocephala Koidz.
It is applicable to Atractylodes macrocephala rhizome that is sold and used as a natural medicine in
international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces
derived from the 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 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 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
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases
...