ISO 4154:2022 PDF

Name: ISO 4154:2022 — Traditional Chinese medicine — Sinomenium acutum stem
SKU: ISO 4154:2022
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Traditional Chinese medicine — Sinomenium acutum stem

Название (английский):

ISO 4154:2022

Traditional Chinese medicine — Sinomenium acutum stem

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 10
Дата публикации:: 12 мая 2022 г.
Издание:: ISO IS 4154 edition 1 version 1
ICS:: 11.120.10

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Описание (английский):

This document specifies the minimum quality and safety requirements of Sinomenium acutum stem [the dried lianoid stem of Sinomenium acutum (Thunb.) Rehd. et Wils. and Sinomenium acutum (Thunb.) Rehd. et Wils. var. cinereum Rehd. et Wils.]. This document applies to Sinomenium acutum stem that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 4154:2022 - Traditional Chinese medicine - Sinomenium acutum stem defines international minimum quality and safety requirements for the dried lianoid stem of Sinomenium acutum (including var. cinereum). The standard applies to raw Chinese materia medica and decoction pieces sold and used as natural medicines in international trade. Its purpose is to harmonize quality control, protect patient safety and support regulatory and commercial consistency for this widely used TCM ingredient.

Key topics and technical requirements

Identity and description

Macroscopic and microscopic descriptions (stem morphology, bark, pith, wood rays, epidermis, xylem/phloem features).
Powder characteristics (color, cell types, calcium oxalate crystals).

Chemical and analytical identification

Thin-layer chromatogram (TLC): sample must show spots matching reference solutions.
Marker compound: sinomenine (C19H23NO4) content not less than 0.50% of dried material when used as the marker.

Quality limits

Moisture: mass fraction ≤ 13.0%
Total ash: mass fraction ≤ 6.0%
Acid‑insoluble ash: mass fraction ≤ 0.5%

Safety testing

Determination of heavy metals (e.g., arsenic, mercury, lead, cadmium).
Determination of pesticide residues.

Sampling and test methods

Sampling per ISO 23723:2021 (Clause 8).
Test methods reference ISO/TS 21310 (microscopy), ISO 18664 (heavy metals), ISO 22258 (pesticide residues), and other ISO test procedures or informative annexes (moisture, TLC, HPLC-UV for marker compound).

Packaging, storage, labelling

Requirements for storage, transport and labelling are included to ensure product integrity in trade.

Applications and practical value

Manufacturers and processors: set incoming raw material acceptance criteria and validate processing/decoction piece quality.

Quality control and analytical laboratories: implement standardized test methods (TLC, moisture, ash, heavy metals, pesticide screens, HPLC for sinomenine).

Regulators and customs/importers: assess compliance of Sinomenium acutum stem in international trade and align national pharmacopoeial requirements.

Product formulators and TCM companies: ensure consistent sinomenine content and safety profile in proprietary medicines (e.g., anti‑rheumatic preparations).

Supply chain managers: apply harmonized sampling and storage rules to reduce recalls and adverse events.

Related standards

ISO 23723:2021 - General requirements for herbal raw material and materia medica (sampling)

ISO/TS 21310 - Microscopic examination of medicinal herbs

ISO 18664 - Determination of heavy metals in TCM herbal medicines

ISO 22258 - Determination of pesticide residues by gas chromatography

ISO 21371 - Labelling requirements for TCM products

ISO 22217 - Storage requirements for raw materials and decoction pieces

Keywords: ISO 4154:2022, Sinomenium acutum stem, traditional Chinese medicine, sinomenine, quality and safety requirements, TLC identification, heavy metals, pesticide residues, moisture limit, total ash.

ISO 4154:2022 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and practical value

Related standards

Технические детали

ISO 23723:2021

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

ISO/TS 21310:2020

Traditional Chinese medicine — Microscopic examination of medicinal herbs

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 2137:1972

Petroleum products — Lubricating grease — Determination of cone penetration

ISO 22217:2020

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