ISO 8959:2024 PDF

Name: ISO 8959:2024 — Traditional Chinese medicine — Eucommia ulmoides stem bark
SKU: ISO 8959:2024
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Traditional Chinese medicine — Eucommia ulmoides stem bark

Название (английский):

ISO 8959:2024

Traditional Chinese medicine — Eucommia ulmoides stem bark

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 16
Дата публикации:: 23 августа 2024 г.
Издание:: ISO IS 8959 edition 1 version 1
ICS:: 11.120.10

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Описание (английский):

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.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

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.

ISO 8959:2024 PDF

Abstract

Похожие стандарты

Overview - ISO 8959:2024 for Eucommia ulmoides stem bark

Key topics and technical requirements

Practical applications and users

Related standards

Технические детали

ISO 23723:2021

Traditional Chinese medicine — General requirements for herbal raw material and materia medica

ISO 18664:2015

Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in Traditional Chinese…

ISO 22258:2020

Traditional Chinese medicine — Determination of pesticide residues in natural products by gas chromatography

ISO 22590:2020

Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration

ISO 2137:1972

Petroleum products — Lubricating grease — Determination of cone penetration

ISO 22217:2020

Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces