ISO 8959:2024

Traditional Chinese medicine - Eucommia ulmoides stem bark

This document specifies the minimum requirements and test methods for Eucommia ulmoides stem bark. It is applicable to Eucommia ulmoides stem bark that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and raw decoction pieces. It is not applicable to processed decoction pieces of Eucommia ulmoides stem bark.

Médecine traditionnelle chinoise — Écorce d'Eucommia ulmoides

General Information

• Status: Published
• Publication Date: 22-Aug-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: 23-Aug-2024
• Due Date: 24-Nov-2024
• Completion Date: 23-Aug-2024

Overview - ISO 8959:2024 for Eucommia ulmoides stem bark

ISO 8959:2024 is the first edition (August 2024) international standard that specifies minimum requirements and test methods for Eucommia ulmoides stem bark used as natural medicines and Chinese materia medica in international trade. The standard applies to whole medicinal materials and raw decoction pieces but is not applicable to processed decoction pieces. Its purpose is to harmonize quality, safety and identification criteria for this traditional Chinese medicine (TCM) ingredient across markets.

Key topics and technical requirements

• Scope and descriptions: botanical source (Eucommia ulmoides Oliv.), macroscopic traits (flat pieces, 0.3–0.7 cm thick, pale brown/greyish-brown outer surface, dark‑purple inner surface), slight odour, slightly bitter taste.
• Microscopic characteristics: transverse section features (cork, 5–7 bands of lignified stone cells in phloem) and powder features (sclereids 20–80 µm, up to 180 µm).
• Quantitative limits:
  • Moisture: mass fraction ≤ 13.0%
  • Total ash: mass fraction ≤ 10.0%
  • Acid‑insoluble ash: to be determined (test required)
• Chemical and safety tests:
  • Thin‑layer chromatography (TLC) identification - sample must match reference medicine spots (Annex A).
  • Ethanol‑soluble extractives and marker compound(s) (e.g., pinoresinol diglucoside) - determination methods included (Annex B describes HPLC‑UV).
  • Contaminants: heavy metals (As, Hg, Pb, Cd), pesticide residues (e.g., BHC, DDT), and sulfur dioxide residues - test methods referenced.
• Sampling and test methods: sampling in accordance with ISO 23723; macroscopic ID requires ≥ 500 g per batch. Test report, packaging, storage, transportation, marking and labelling requirements are specified.

Practical applications and users

This ISO standard is intended for:

• Herbal medicine manufacturers and processors who source, grade or sell Eucommia ulmoides stem bark.
• Quality control and analytical laboratories performing TLC, HPLC‑UV, heavy metal and pesticide assays.
• Regulatory authorities, exporters/importers and procurement teams seeking harmonized acceptance criteria for international trade.
• Pharmacopoeia bodies and standards developers aligning national requirements (Annex C lists national/regional values).

Practical uses include product specification development, incoming material inspection, supplier qualification, safety compliance, and prevention of adulteration or improper processing.

Related standards

• ISO 23723 - General requirements for herbal raw material and materia medica (sampling reference)
• ISO 18664 - Determination of heavy metals in TCM
• ISO 22258 - Determination of pesticide residues
• ISO 22590 - Determination of sulfur dioxide
• ISO 21371 and ISO 22217 - Labelling and storage requirements for TCM products

Keywords: ISO 8959:2024, Eucommia ulmoides stem bark, traditional Chinese medicine standard, pinoresinol diglucoside, TLC, HPLC‑UV, moisture limit, total ash, heavy metals, pesticide residues.

Standards Content (Sample)

International
Standard
ISO 8959
First edition
Traditional Chinese medicine —
2024-08
Eucommia ulmoides stem bark
Médecine traditionnelle chinoise — Écorce d'Eucommia
ulmoides
Reference number
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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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 . 2
5.1 General characteristics .2
5.2 Macroscopic characteristics .3
5.3 Microscopic characteristics .3
5.3.1 Transverse section . . .3
5.3.2 Powder .3
5.4 Moisture .4
5.5 Total ash .4
5.6 Acid-insoluble ash .4
5.7 Thin-layer chromatogram .5
5.8 Ethanol-soluble extractives .5
5.9 Content of marker compound(s) .5
5.10 Heavy metals .5
5.11 Pesticide residues .5
5.12 Sulfur dioxide residues . .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 acid-insoluble ash .5
7.5 Thin-layer chromatographic identification .5
7.6 Determination of ethanol-soluble extractives .6
7.7 Determination of marker compound(s).6
7.8 Determination of heavy metals .6
7.9 Determination of pesticide residues .6
7.10 Sulfur dioxide residues . .6
8 Test report . 6
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Thin-layer chromatographic (TLC) identification . 8
Annex B (informative) Determination of marker compound(s) by HPLC-UV .10
Annex C (informative) National and regional requirements for Eucommia ulmoides stem bark . 14
Bibliography .16

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
Eucommia ulmoides stem bark has the effects of nourishing the liver and kidneys and strengthening bones.
It is recorded in Compendium of Materia Medica and Sheng Nong’s herbal classic, and is clinically used in
the treatment of hypertension, chronic kidney disease, arthritis and other diseases. Various commodity
specifications of Eucommia ulmoides stem bark, including its medicinal materials, decoction pieces and
extracts, are widely traded in China, the Republic of Korea, Japan, Malaysia, Vietnam, Singapore, Thailand,
Canada and the United States of America. Although Eucommia ulmoides stem bark has been included in
several national pharmacopoeias and regional standards, the requirements differ. In addition, there are
many problems with Eucommia ulmoides stem bark products on the market, such as mixed use of non-
medicinal parts and irregular processing, which can lead to a decline in the quality of this medicinal herb.
Therefore, it is necessary to establish a unified International Standard to guarantee the quality and safety of
Eucommia ulmoides stem bark.
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 C.

v
International Standard ISO 8959:2024(en)
Traditional Chinese medicine — Eucommia ulmoides stem bark
1 Scope
This document specifies the minimum requirements and test methods for Eucommia ulmoides stem bark.
It is applicable to Eucommia ulmoides stem bark that is sold and used as natural medicines in international
trade, including Chinese materia medica (whole medicinal materials) and raw decoction pieces.
It is not applicable to processed decoction pieces of Eucommia ulmoides stem bark.
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 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
Eucommia ulmoides stem bark
outer covering of the stem of Eucommia ulmoides Oliv.
3.2
reference medicine
authentic medicine from Eucommia ulmoides stem bark (3.1) used for reference in thin-layer chromatographic
analyses of the sample
3.3
batch
samples collected from the same particular place at the same time
[SOURCE: ISO 21317:2019, 3.5]
4 Descriptions
Eucommia ulmoides stem bark is the dried stem bark of Eucommia ulmoides Oliv. in the family of
Eucommiaceae, as shown in Figure 1.
Key
1 fruiting branch
2 flowering branch
3 male flower
4 female flower
5 stamen lateral view
6 ovary longitudinal section
7 stem bark
8 rubber thread
Figure 1 — Structure of Eucommia ulmoides stem bark
5 Requirements
5.1 General characteristics
The following requirements shall be met before sampling:
a) Eucommia ulmoides stem bark shall be clean and dry.
b) The presence of living insects, mouldy root and external contaminants which are visible to the naked
eye shall not be permitted.
5.2 Macroscopic characteristics
They are in flat pieces or the two edges somewhat curved inward, varying in size and 0,3 cm to 0,7 cm
thick. The outer surface is pale brown or greyish-brown, markedly wrinkled or fissured and channelled
longitudinally. Some pieces are relatively thin, showing distinct lenticels when the coarse bark is unscraped.
The inner surface is dark purple and smooth. The texture is fragile, easily broken, fracture linked by fine,
dense, silvery, elastic and resinous threads. The odour is slight and the taste is slightly bitter.
5.3 Microscopic characteristics
5.3.1 Transverse section
The transverse section sometimes shows evidence of rhytidome outside the cork cells. Cork consists of
several rows of cells. Phloem consists of five to seven bands of lignified stone cells; each band contains two
to six rows of stone cells, with fibres nearby. Phloem rays are two to three cells wide. Resinous masses are
scattered.
5.3.2 Powder
The colour is
...