ISO 22988:2020 PDF

Name: ISO 22988:2020 — Traditional Chinese medicine — Astragalus mongholicus root
SKU: ISO 22988:2020
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Traditional Chinese medicine — Astragalus mongholicus root

Название (английский):

ISO 22988:2020

Traditional Chinese medicine — Astragalus mongholicus root

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 19
Дата публикации:: 9 января 2020 г.
Издание:: ISO IS 22988 edition 1 version 1
ICS:: 11.120.10

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Описание (английский):

This document specifies the quality and safety requirements of Astragalus mongholicus root [root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao]. This document applies to Astragalus mongholicus root that is sold and used as natural medicine 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 22988:2020 - Traditional Chinese medicine - Astragalus mongholicus root - is an international standard that defines quality and safety requirements for dried Astragalus mongholicus root (the herbal drug often called Huang Qi, Astragali Radix). The standard applies to Astragalus mongholicus root sold or used as natural medicine in international trade, including whole Chinese materia medica and decoction pieces. ISO 22988:2020 helps ensure consistent identity, safety and suitability of Astragalus root in global commerce and clinical use.

Key topics and technical requirements

ISO 22988:2020 covers identification, compositional tests and safety controls with detailed test methods and sampling procedures. Major technical topics include:

Morphological features: macroscopic descriptions and root structure (tap root, fibrous roots, epidermis, phloem, xylem).

Identity and chemical markers: identification by thin-layer chromatography and quantification of marker compounds such as astragaloside I, II and IV; calycosin, calycosin-7-glucoside, formononetin and ononin.

Quality parameters: determination of total polysaccharides, water-soluble extractives, total ash and moisture content.

Safety limits and testing: procedures for heavy metals and pesticide residues analysis to ensure consumer safety.

Physical specifications: sampling rules, root length and diameter measurements, and grade classifications.

Test methods and reporting: defined laboratory methods (TLC, gravimetric, HPLC/DNA methods referenced where applicable) and required test reports.

Packaging, storage and labelling: guidance for protecting quality during transport and sale; labelling requirements for oral or topical TCM products.

Note: ISO provides methods and reference requirements; national/regional bodies may adapt numerical values (see Annex F for examples).

Practical applications and intended users

ISO 22988:2020 is useful for:

Manufacturers and processors of decoction pieces and herbal medicines to implement consistent quality control.

Quality control laboratories performing identity, purity and contaminant testing.

Exporters and importers engaged in international trade who must meet importing-country requirements.

Regulators and pharmacopoeia committees harmonizing safety standards for Traditional Chinese Medicine (TCM).

Practitioners and formulary developers seeking assurance of raw material consistency.

Adoption of ISO 22988 supports product safety, regulatory compliance, traceability and consumer confidence in Astragalus mongholicus root.

Related standards

Relevant documents referenced in ISO 22988 include:

ISO 1575 (total ash), ISO 18664 (heavy metals in TCM), ISO 21371 (labelling), ISO 22217 / ISO 22258 (storage and pesticide determination) and WHO Quality control methods for herbal materials. These help implement the standard’s testing, storage and labelling provisions.

ISO 22988:2020 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and intended users

Related standards

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