ISO 5076:2024

Traditional Chinese medicine - Angelica dahurica root

This document specifies the quality and safety requirements of Angelica dahurica root [the dried root of Angelica dahurica (Fish.ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav.]. This document applies to Angelica dahurica root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.

Titre manque

General Information

• Status: Published
• Publication Date: 21-May-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: 22-May-2024
• Due Date: 01-Apr-2025
• Completion Date: 22-May-2024

Overview

ISO 5076:2024 - Traditional Chinese medicine - Angelica dahurica root defines quality and safety requirements for Angelica dahurica root (dried root of Angelica dahurica) used as natural medicine in international trade. The standard covers whole Chinese materia medica and decoction pieces, specifying morphological description, compositional markers, limits for impurities, and required test/reporting and handling practices to ensure product consistency and consumer safety.

Key topics and technical requirements

• Scope & description: Applies to dried Angelica dahurica root (commonly called baizhi) including size and appearance characteristics (roots typically 10–25 cm long, 1.5–2.5 cm diameter; greyish- to yellowish-brown surface; aromatic odor, pungent/slightly bitter taste).
• Morphology & macroscopic ID: Visual, smell and taste inspection for physical integrity, absence of mould, live insects and foreign matter.
• Chemical & analytical identification:
  • Thin-layer chromatogram (TLC) identification to match reference spots.
  • Marker compound determination (e.g., imperatorin, C16H14O4) to confirm chemical identity and potency.
• Quality limits:
  • Total ash content ≤ 7.0% (mass fraction).
  • Dilute ethanol (50%)‑soluble extractives ≥ 15.0% when measured.
  • Moisture, acid-insoluble ash, and other extractable contents to be determined.
• Contaminants:
  • Determination of heavy metals (arsenic, mercury, lead, cadmium).
  • Determination of pesticide residues.
• Sampling & test methods: Sampling per ISO 23723; test methods reference ISO 23723, ISO 18664 (heavy metals), ISO 22258 (pesticides), and specific annexes for TLC and marker assays.
• Reporting & labelling: Test report must identify sample, methods, results and anomalies. Packaging, storage and transport must prevent contamination and odor transfer; labelling follows ISO 21371.

Applications and who uses it

• Herbal raw material producers and processors - to meet international quality and safety expectations for exports.
• Pharmaceutical and nutraceutical manufacturers - for ingredient specification, batch release and supplier qualification.
• Analytical laboratories and quality-control units - to perform TLC, marker assays and contaminant testing following standardized methods.
• Regulators, importers and customs authorities - for conformity assessment, risk management and harmonized inspection criteria.
• Traditional Chinese medicine practitioners and wholesalers - to ensure consistent therapeutic raw material quality in global trade.

Related standards

• ISO 23723 - General requirements for herbal raw material and materia medica
• ISO 18664 - Determination of heavy metals in TCM herbal medicines
• ISO 22258 - Determination of pesticide residues by gas chromatography
• ISO 22217 - Storage requirements for raw materials and decoction pieces
• ISO 21371 - Labelling requirements for TCM products

Keywords: ISO 5076:2024, Angelica dahurica root, Traditional Chinese medicine, TLC identification, imperatorin, heavy metals, pesticide residues, herbal quality standard, international trade.

Standards Content (Sample)

International
Standard
ISO 5076
First edition
Traditional Chinese medicine —
2024-05
Angelica dahurica root
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
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 .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 1
5 Quality and safety requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological features .2
5.3 Thin-layer chromatogram (TLC) identification .3
5.4 Moisture .3
5.5 Total ash .3
5.6 Acid-insoluble ash .3
5.7 Dilute ethanol-soluble extractives .3
5.8 Heavy metals .3
5.9 Pesticide residues .3
5.10 Marker compound .3
6 Sampling . 3
7 Test methods . 3
7.1 Macroscopic identification .3
7.2 Thin-layer chromatogram (TLC) identification .4
7.3 Determination of moisture content .4
7.4 Determination of total ash content .4
7.5 Determination of acid-insoluble ash content .4
7.6 Determination of dilute ethanol-soluble extractives 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 . 4
9 Packaging, storage and transportation . 4
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatogram (TLC) identification . 6
Annex B (informative) Determination of marker compound . 8
Annex C (informative) Reference information of national and regional requirements .10
Bibliography .12

iii
Foreword
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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
Angelica dahurica root (also known as Angelicae dahuricae Radix or "baizhi") is one of the commonly used
herbal medicines in traditional Chinese medicine (TCM). For instance, of 1607 formulae in the Pharmacopoeia
[1]
of the People's Republic of China (2020 edition), 131 (8,2 %) contain the Angelica dahurica root.
[2]
Angelica dahurica root was firstly recorded in “Shen Nong Ben Cao Jing” (神农本草经), and has been used in
TCM for a very long time to treat headache, supraorbital neuralgia, stuffy nose, nasosinusitis and toothache.
Modern pharmacological studies demonstrate that Angelica dahurica root possesses anti-inflammatory,
antioxidant, antibacterial, and anticancer properties. The main chemical constituents of Angelica dahurica
root are coumarins and volatile oils. The coumarins contained in Angelica dahurica root, such as imperatorin
and isoimperatorin, have been demonstrated to have anticancer, antiviral, antidepressive, antiallergic, anti–
lipogenic, antioxidant, vasodilation and radical–scavenging effects.
In the global trade of Angelica dahurica root, mainland China is a main exporter. According to China customs
data from 2015 to 2019, the average annual export volume of Angelica dahurica root was 2 557 tons, worth
11 891 630 US$. The main destination countries and regions included Japan, the Republic of Korea, Hong
Kong, Taiwan, Vietnam, Malaysia, Thailand, New Zealand, the United States and Germany.
[1]
Angelica dahurica root has been recorded in the Pharmacopoeia of the People's Republic of China, the
[3] [4] [5]
European Pharmacopoeia, the Japanese Pharmacopoeia and the Korean Pharmacopoeia ; and the
requirements of each pharmacopoeia are different. Currently, there's no globally unified standard for
Angelica dahurica root; and regulators in many countries and regions have different levels of regulation.
Therefore, the establishment of an International Standard is necessary to guarantee the quality, safety and
consistency of the valuable herbal medicine.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.5 and 5.7 in their national standards. Example of national values are given in Annex C.

v
International Standard ISO 5076:2024(en)
Traditional Chinese medicine — Angelica dahurica root
1 Scope
This document specifies the quality and safety requirements of Angelica dahurica root [the dried root of
Angelica dahurica (Fish.ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav.].
This document applies to Angelica dahurica root that is sold and used as 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 23723, Traditional Chinese medicine — General requirements for herbal raw material and materia medica
3 Terms and definitions
Fo
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