ISO 4564:2023 PDF

Name: ISO 4564:2023 — Traditional Chinese medicine — Scutellaria baicalensis root
SKU: ISO 4564:2023
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Traditional Chinese medicine — Scutellaria baicalensis root

Название (английский):

ISO 4564:2023

Traditional Chinese medicine — Scutellaria baicalensis root

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 12
Дата публикации:: 22 мая 2023 г.
Издание:: ISO IS 4564 edition 1 version 1
ICS:: 11.120.10

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Описание (английский):

This document specifies minimum requirements and test methods for root of Scutellaria baicalensis, which is derived from cultivated Scutellaria baicalensis Georgi. This document applies to Scutellaria baicalensis root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 4564:2023 specifies minimum requirements and test methods for the root of Scutellaria baicalensis (Baikal/Chinese skullcap) derived from cultivated Scutellaria baicalensis Georgi. The standard covers whole Chinese materia medica and decoction pieces sold and used as natural medicines in international trade. Its purpose is to provide systematic, reproducible criteria for quality control of Scutellaria baicalensis root used in Traditional Chinese Medicine (TCM) and related pharmaceutical applications.

Key topics and technical requirements

Scope & applicability: Applies to cultivated Scutellaria baicalensis root for medicinal use (whole materials and decoction pieces).

Description & morphology: Defines macroscopic features (size, colour, texture, fracture) and detailed morphological traits used for identification.

Microscopic identification: Transverse section and powder characteristics (cork, phloem, xylem, starch granules) for laboratory confirmation.

Chemical and physical limits:

Moisture content: ≤ 15.0% (subject to national modification).
Total ash: ≤ 6.0% (subject to national modification).
Ethanol‑soluble extractives: to be determined according to methods cited.

Marker compounds: Quantification required for baicalin, baicalein, and wogonin; Thin-layer chromatography (TLC) identification for baicalin is specified.

Contaminant testing:

Heavy metals (arsenic, mercury, lead, cadmium) - methods referenced.
Pesticide residues - methods referenced.

Sampling & test methods: Sampling procedures, minimum sample sizes, and testing protocols are specified or referenced to other ISO documents.

Quality assurance: Test report content, packaging/storage/transportation requirements, and labelling/marking guidance are included.

Annexes: Informative annexes provide TLC identification (Annex A), marker compound determination (Annex B), and national/regional requirement examples (Annex C).

Practical applications and users

ISO 4564:2023 is intended for:

Quality control and analytical laboratories verifying authenticity and purity of Scutellaria baicalensis root.

Herbal product manufacturers and pharmaceutical companies producing TCM formulations and decoction pieces.

Importers, exporters and customs authorities involved in international trade of Chinese materia medica.

Regulatory agencies and standards bodies integrating harmonized test methods into national pharmacopoeias.

TCM practitioners and formulary developers who require validated quality specifications.

Related standards

Normative references in ISO 4564:2023 include:

ISO 23723 (general requirements & sampling), ISO/TS 21310 (microscopy), ISO 18664 (heavy metals), ISO 22258 (pesticide residues), ISO 22217 (storage), ISO 21371 (labelling).

Keywords: ISO 4564:2023, Scutellaria baicalensis root, Traditional Chinese Medicine, quality control, baicalin, baicalein, wogonin, TLC, heavy metals, pesticide residues, Chinese materia medica.

ISO 4564:2023 PDF

Abstract

Похожие стандарты

Overview

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/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 22217:2020

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

ISO 2137:1972

Petroleum products — Lubricating grease — Determination of cone penetration