ISO 19047:2025

Traditional Chinese Medicine - Polygonum multiflorum root

This document specifies the quality and safety requirements and test methods of Polygonum multiflorum root, which is derived from the dried root of Polygonum multiflorum Thunb. (Fam. Polygonaceae). This document is applicable to raw and processed Polygonum multiflorum root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal material) and decoction pieces derived from this plant.

Médecine traditionnelle chinoise — Racine de Polygonum multiflorum

General Information

• Status: Published
• Publication Date: 13-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: 14-Oct-2025
• Due Date: 20-Jan-2026
• Completion Date: 14-Oct-2025

Overview

ISO 19047:2025 - Traditional Chinese Medicine - Polygonum multiflorum root is the first international standard that specifies quality, safety requirements and test methods for Polygonum multiflorum Thunb. root (commonly known as Heshouwu or Fallopia/Reynoutria multiflora). It applies to raw and processed Polygonum multiflorum root used as natural medicines and decoction pieces in international trade, providing harmonized criteria for manufacturers, testing laboratories, regulators and traders involved in herbal medicine and Chinese materia medica.

Key topics and technical requirements

ISO 19047:2025 defines both descriptive and analytical controls to support reliable quality control and safety evaluation:

• Identification and description
  • Macroscopic morphology: shape (briquette/irregular spindle), external colour (reddish‑brown), dimensions (length 6–15 cm; diameter 4–12 cm), texture and fracture characteristics.
  • Microscopic features: cork cell layers, phloem with 4–11 subrounded vascular bundles, starch granules (simple and compound, 4–50 µm), cluster calcium oxalate (10–80 µm, sometimes up to 160 µm), pitted annular vessels.
• Quality and safety assays
  • Physicochemical tests: moisture content, total ash, water‑soluble extractives.
  • Chemical identification: Thin‑layer chromatogram (TLC) profiling and marker compound determination (see Annex B for 2,3,5,4'‑tetrahydroxystilbene‑2‑O‑β‑D‑glucoside).
  • Constituents: determination of total anthraquinone glycosides (Annex C).
  • Contaminant limits and testing: heavy metals and pesticide residues with referenced test methods.
• Other requirements
  • Sampling procedures, test reporting, packaging, storage, transportation, and labelling requirements for oral or topical use.

Practical applications and users

ISO 19047:2025 is designed for practical use across the supply chain:

• Quality control laboratories - adopt standardized test methods (TLC, moisture, ash, marker assays) to verify authenticity and batch quality.
• Manufacturers and processors - ensure raw and processed Polygonum multiflorum root meet international specifications for export and domestic distribution.
• Regulators and conformity assessors - use the standard to set or harmonize national requirements, monitor safety (heavy metals, pesticides) and reduce adulteration.
• Traders and importers/exporters - apply consistent acceptance criteria for Chinese materia medica and decoction pieces in international trade.
• Researchers and herbalists - reference diagnostic morphological and microscopic features and validated analytical methods.

Related standards and references

ISO 19047 cites and aligns with other ISO documents for methods and handling:

• ISO 18664 (heavy metals), ISO/TS 21310 (microscopy), ISO 21371 (labelling), ISO 22217 (storage), ISO 22258 (pesticide residues), and ISO 23723 (general herbal raw material requirements).
• Informative annexes (A–D) provide TLC identification guidance, marker compound and anthraquinone assay procedures, and national/regional reference values.

Keywords: ISO 19047:2025, Polygonum multiflorum, Heshouwu, Traditional Chinese Medicine, herbal medicine standard, quality control, TLC identification, marker compounds, heavy metals, pesticide residues, decoction pieces.

Standards Content (Sample)

International
Standard
ISO 19047
First edition
Traditional Chinese Medicine —
2025-10
Polygonum multiflorum root
Médecine traditionnelle chinoise — Racine de Polygonum
multiflorum
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
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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 . 1
5 Quailty and safey requirements and recommendations . 2
5.1 General .2
5.2 Morphological features .2
5.2.1 Appearance .2
5.2.2 Colour .2
5.2.3 Dimensions .2
5.2.4 Texture .3
5.2.5 Fracture .3
5.2.6 Odour .3
5.3 Microscopic identification .3
5.4 Moisture .4
5.5 Total ash .4
5.6 Water-soluble extractives .4
5.7 Thin-layer chromatogram (TLC) identification .4
5.8 Marker compound(s) .5
5.9 Heavy metals .5
5.10 Pesticide residues .5
6 Sampling . 5
7 Test method . 5
7.1 Macroscopic identification .5
7.2 Microscopic identification .5
7.3 Determination of moisture content .5
7.4 Determination of total ash content .5
7.5 Water-soluble extractives .5
7.6 Thin-layer chromatogram (TLC) identification .5
7.7 Determination of marker compound(s).5
7.8 Determination of heavy metals contents .5
7.9 Determination of pesticide residues contents.6
8 Test report . 6
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Thin-layer chromatogram (TLC) identification . 7
Annex B (informative) Determination of 2,3,5,4'-tetrahydroxystilbene-2-O-β-D-glucoside
content . 9
Annex C (informative) Determination of total anthraquinone glycosides content .11
Annex D (informative) Reference values of Polygonum multiflorum root in different national
and regional standards . 14
Bibliography . 17

iii
Foreword
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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
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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
complete listing of these bodies can be found at www.iso.org/members.html.

iv
Introduction
Polygonum multiflorum root (also called Fallopia multiflora root) is the dried root of Polygonum multiflorum
Thunb. (Fam. Polygonaceae), which is known as Heshouwu (何首乌 in Chinese) in China. It has a long history
of medicinal use in East Asian countries and is traditionally valued and reported for its hair-blacking, liver-
and kidney-tonifying and anti-aging effects as well as its low toxicity.
Although Polygonum multiflorum root and its related prescriptions are limited in the international market
due to concerns over liver injury, there is still a large demand for Polygonum multiflorum root in the Chinese
materia medica market to date; 200 t to 300 t per year of Polygonum multiflorum root are exported to
Japan, the Republic of Korea, Hongkong (China), and other countries and regions. In addition, Polygonum
multiflorum root is ranked no. 26 in the priority list of single herbal medicines for developing standards in
ISO/TR 23975:2025.
There is currently no unified International Standard for Polygonum multiflorum root. The regulatory
authorities in many countries have not adequately differentiated the adulterants of Polygonum multiflorum
root. Additionally, the quality of Polygonum multiflorum root provided from different areas varies a lot.
Therefore, an International Standard for Polygonum multiflorum root in terms of quality control of this herb
and its products is required to ensure the safe use of these medicinal materials.
As national implementation can 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 D.

v
International Standard ISO 19047:2025(en)
Traditional Chinese Medicine — Polygonum multiflorum root
1 Scope
This document specifies the quality and safety requirements and test methods of Polygonum multiflorum
root, which is derived from the dried root of Polygonum multiflorum Thunb. (Fam. Polygonaceae).
This document is applicable to raw and processed Polygonum multiflorum root that are sold and used as
natural medicines in international trade, including Chinese materia medica (whole medicinal material) and
decoction pieces derived from this 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/TS 21310, Traditional Chinese medicine — Microscopic examination of medicinal herbs
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 23723:2021, 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 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
Polygonum multiflorum root
Fallopia multiflora root
Reynoutria multiflora root
dried root of Polygonum multiflorum Thunb [syn. Reynoutria multiflora (Thunb.) Moldenke; Fallopia multiflora
(Thunb.) Haraldson] in the family of Polygonaceae
4 Descriptions
In this document, the structure of Polygonum multiflorum Thunb. (Fam. Polygonaceae) and the dried root are
shown in Figure 1.
a) plant of Polygonum multiflorum Thunb. b) Polygonum multiflorum root
Key
1 length
2 diameter
Figure 1 — Structure of the plant and root of Polygonum multiflorum Thunb.
5 Quailty and safey requirements and recommendations
5.1 General
The following requirements shall be met before the sampling (see Clause 6).
a) Polygonum multiflorum root shall be clean and free from leaf, stem and foreign matter.
b) The presence of living insects, mouldy root and external contaiminants which are visible to the naked
eye shall not be permitted.
5.2 Morphological features
5.2.1 Appearance
The root is in the shape of a briquette or an irregular spindle.
5.2.2 Colour
The external surface of the root is reddish-brown with irregular wrinkles, transverse elongated lenticel-like
protrusion, and fine rootlet scars.
5.2.3 Dimensions
The root is 6 cm to 15 cm in length measured from the base to the end of the root, and 4 cm to 12 cm in
diameter measured at the middle of the root.

5.2.4 Texture
The texture is dense, compact and not easily broken.
5.2.5 Fracture
The fracture is pale yellowish-brown or reddish-brown. The drug is powdery when fractured. The phloem
exhibits 4 to 11 subround allotype vascular bundles arranged in a ring, forming brocaded patterns; the
xylem in the central part is larger with an occasionally woody core.
5.2.6 Odour
The odour is slight and characteristic; and the taste is slightly bitter and astringent.
5.3 Microscopic identifica
...