ISO 24049:2025

Traditional Chinese medicine - Aconitum carmichaelii parent root tuber

This document specifies minimum requirements and test methods for Aconitum carmichaelii parent root tuber. This document applies to Aconitum carmichaelii parent root tuber that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant. Processing methods and processed products of Aconitum carmichaelii parent root tuber are excluded.

Médecine traditionnelle chinoise — Tubercule parent d'Aconitum carmichaelii

General Information

• Status: Published
• Publication Date: 20-Oct-2025
• 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: 21-Oct-2025
• Due Date: 13-Dec-2026
• Completion Date: 21-Oct-2025

Overview

ISO 24049:2025 - Traditional Chinese medicine - Aconitum carmichaelii parent root tuber provides an international quality-control framework for the dried parent root tuber of Aconitum carmichaelii (Aconiti Radix, Chuanwu). It specifies minimum requirements and test methods for material sold and used as natural medicines in international trade (whole medicinal materials and decoction pieces). Processing methods and processed products are excluded.

Key topics and requirements

• Scope and definitions: Applies to unprocessed dried parent root tuber used as herbal medicine; defines botanical identity and collection/drying practices.
• Identity and description: Macroscopic (shape, size, colour, fracture, texture) and microscopic characteristics (transverse section, powder features) for botanical verification.
• Chemical markers: Uses aconitine, mesaconitine and hypaconitine as principal marker compounds; includes provisions for marker-compound testing to assess potency and safety.
• Safety tests and limits: Requirements and test methods for moisture, total ash, acid‑insoluble ash, heavy metals and pesticide residues to ensure product safety and quality.
• Analytical methods:
  • Thin-layer chromatography (TLC) identification (Annex A informative)
  • Reference to HPLC methods for Aconitum alkaloids (ISO 23191)
  • Protocols for microscopic and macroscopic examination, moisture and ash determinations
• Sampling and test reporting: Procedures for representative sampling, required test-report content and documentation of results.
• Packaging, storage, labelling: Requirements to preserve quality during storage and transportation; labelling according to relevant TCM labelling rules.
• Regional flexibility: National bodies may adapt numeric values for limits (moisture, ash, marker compounds, heavy metals); Annex B gives examples of national/regional values.

Applications and users

ISO 24049:2025 is intended for practical use by:

• Manufacturers and suppliers of Chinese materia medica to ensure raw-material quality and compliance for international trade.
• Analytical and quality-control laboratories conducting identity and safety testing (TLC, HPLC, heavy metals, pesticide residue assays).
• Regulators and customs authorities setting import/export controls and safety criteria for Aconitum products.
• Traditional Chinese medicine practitioners and distributors who require standardized quality assurance for clinical safety.
• Standards bodies and harmonization initiatives working to align national regulations for toxic Aconitum alkaloids.

Related standards

Key referenced standards include:

• ISO 23191 (HPLC determination of selected Aconitum alkaloids)
• ISO 18664 (heavy metals in TCM)
• ISO 22258 (pesticide residues by GC)
• ISO/TS 21310 (microscopic examination)
• ISO 21371 (labelling), ISO 22217 (storage), ISO 23723 (general herbal raw material requirements)

ISO 24049:2025 supports safer, harmonized quality control for Aconitum carmichaelii in international trade by combining botanical, chemical and safety testing requirements.

Standards Content (Sample)

International
Standard
ISO 24049
First edition
Traditional Chinese medicine —
2025-10
Aconitum carmichaelii parent
root tuber
Médecine traditionnelle chinoise — Tubercule parent d'Aconitum
carmichaelii
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
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or ISO’s member body in the country of the requester.
ISO copyright office
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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 Descriptions . 2
5 Requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological features of root tuber .3
5.3 Microscopic identification .3
5.3.1 Transverse section . . .3
5.3.2 Powder .3
5.4 Thin-layer chromatography identification .4
5.5 Moisture .4
5.6 Total ash .4
5.7 Acid-insoluble ash .4
5.8 Marker compounds .4
5.9 Heavy metals .4
5.10 Pesticide residues .4
6 Sampling . 5
7 Test methods . 5
7.1 Macroscopic identification .5
7.2 Microscopic identification .5
7.3 Thin-layer chromatography identification .5
7.4 Determination of moisture .5
7.5 Determination of total ash .5
7.6 Determination of acid-insoluble ash .5
7.7 Determination of marker compounds .5
7.8 Determination of heavy metal .5
7.9 Determination of pesticide residues .5
8 Test report . 5
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Thin-layer chromatography identification . 7
Annex B (informative) Reference information of national and regional requirements for
Aconitum carmichaelii parent root tuber . 8
Bibliography .10

iii
Foreword
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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
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iv
Introduction
Aconitum carmichaelii parent root tuber (Aconiti Radix, Chuanwu) is the dried parent root of Aconitum
carmichaelii Debx in the Ranunculaceae family. It is a high-value and an important source of medicinal herb
with characteristic analgesic and anti-inflammatory activities. It is first-mentioned in Shen Nong Ben Cao
Jing and widely used in China, Korea and other countries for a long history.
Modern pharmacological studies show that Aconitum carmichaelii parent root tuber has good therapeutic
effects on inflammation, pain, tumours, immune diseases and cardiovascular diseases. The chemical
composition of Aconitum carmichaelii parent root tuber is complex, mainly containing diterpenoid alkaloids,
polysaccharide, volatile oil, flavonoids and saponins. At present, aconitine-type diterpenoid alkaloids are the
main characteristic compounds and principal pharmacological ingredients of Aconitum carmichaelii parent
root tuber. Therefore, aconitine, mesaconitine, and hypaconitine are used as the marker compounds of
[2]
Aconitum carmichaelii parent root tuber in Chinese Pharmacopoeia and Hong Kong Standard for Chinese
[9]
Medicinal Materials .
It's well known for its clinical benefits, as well as its high toxicity. The toxic components of Aconitum
carmichaelii parent root tuber are also its active components. The high toxicity risk and narrow therapeutic
range limit the medicinal application on a larger scale. Diester alkaloids such as aconitine and hypaconitine
have cardiovascular toxicity, nervous-system toxicity and digestive-system toxicity. In recent years, a few
phenomena appeared in the market for aconite products: fake and inferior goods flood the market; many
products are not processed in accordance with the traditional process, increasing the risk related to drug
safety. These not only affect the market environment, but also the safety of clinical medication.
At present, Aconitum carmichaelii parent root tuber and related products are restricted in international
trade by many countries because of the risk of toxic ingredients. Aconitine poisoning caused by improper
use has been reported from time to time. There are various causes of aconite poisoning, including overdoses,
inadequate processing, aconitum contamination in other herbs, and dispensing errors. What’s more, hidden
toxic Aconitum alkaloids, such as yunaconitine, crassicauline A and 8-deacetyl-yunaconitine, were detected
instead of aconitine, hypaconitine, and mesaconitine in the urine samples of the aconitum poisoning patients
in Hong Kong. These hidden toxic Aconitum alkaloids have been found in commonly used Aconitum herbs,
including Aconitum carmichaelii parent root tuber. Therefore, these alkaloids also should be included in the
quality and safety control standards for Aconitum herbs.
However, the standards for Aconitum carmichaelii parent root tuber are not yet harmonized at an
international level and regulatory authorities in many nations do not adequately differentiate highly toxic
forms from less-toxic forms (or even non-toxic forms) of Aconitum carmichaelii parent root tuber. Effectively
controlling and supervising the quality and safety of this medicinal material and expanding its international
market requires more accurate quality control and standardized procedures at every stage.
Therefore, an International Standard is required for the quality control of Aconitum carmichaelii parent
root tuber and related products to ensure the safe use of these medical materials. The establishment of an
International Standard can help improve the safety of Aconitum carmichaelii parent root tuber, make the
quality of its products stable and controllable, ensure safe and effective application of these medicinal
materials in clinical practices, benefit people's health and reduce the occurrence of adverse events.
As national implementation can differ, national standards bodies are invited to modify the values given
in 5.5, 5.6, 5.7 and 5.8 in their national standards. Examples of national and regional values are given in
Annex B.
v
International Standard ISO 24049:2025(en)
Traditional Chinese medicine — Aconitum carmichaelii parent
root tuber
1 Scope
This document specifies minimum requirements and test methods for Aconitum carmichaelii parent root tuber.
This document applies to Aconitum carmichaelii parent root tuber that is sold and used as natural medicines
in internatio
...