ISO 9109:2024 PDF

Name: ISO 9109:2024 — Traditional Chinese medicine — Rehmannia glutinosa root
SKU: ISO 9109:2024
Price: 25 EUR
Availability: InStock

Traditional Chinese medicine — Rehmannia glutinosa root

Название (английский):

ISO 9109:2024

Traditional Chinese medicine — Rehmannia glutinosa root

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 20
Дата публикации:: 8 января 2024 г.
Издание:: ISO IS 9109 edition 1 version 1
ICS:: 11.120.10

Тип поставки:

Full version300 €Read online 24h10 €Read online 72h15 €

Язык документа:

ruen

Срок поставки:4 раб. дн. (перевод)

Цена:300 €

Описание (английский):

This document specifies the requirements and test methods for dried Rehmannia glutinosa root that is derived from Rehmannia glutinosa Libosch. Fresh Rehmannia glutinosa Libosch. and processed Rehmannia glutinosa Libosch. are excluded. This document is applicable to Rehmannia glutinosa root that is sold and used as a 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 9109:2024 - Traditional Chinese medicine - Rehmannia glutinosa root is the first edition International Standard that defines quality requirements and test methods for dried Rehmannia glutinosa root (derived from Rehmannia glutinosa Libosch.). The standard applies to whole medicinal material and decoction pieces traded and used as natural medicine internationally. Fresh and processed Rehmannia root are explicitly excluded.

Keywords: ISO 9109:2024, Rehmannia glutinosa root, traditional Chinese medicine, dried root, Chinese materia medica

Key topics and technical requirements

Scope and exclusions: Applies only to dried root for medicinal use; excludes fresh and processed products.

Description & morphology: Typical root morphology, colour, texture and size (root length ~6–12 cm; diameter ~2–6 cm).

Physical and microscopic characteristics: Macroscopic and powder microscopy features (cork cells, parenchyma, secretory cells, vessels).

Quality limits and tests:

Moisture - mass fraction determined (method referenced).
Total ash - mass fraction not more than 8.0%.
Acid‑insoluble ash - mass fraction not more than 3.0%.
Water‑soluble extractives - mass fraction determined.
TLC identification - marker compounds (e.g., catalpol, verbascoside) must present matching spots/bands (same position and colour) in test and reference solutions.
Marker compound assays - determination of catalpol and rehmannioside D content (informative annexes give identification and assay procedures).
Contaminants - heavy metals (As, Hg, Pb, Cd), pesticide residues (e.g., HCH, DDT, PCNB) and sulfur dioxide residues to be determined.

Sampling & test methods: Sampling according to ISO 23723; test method clauses cover macroscopic ID, moisture, ash, TLC, marker assays, heavy metals, pesticides and sulfur dioxide.

Additional provisions: Grading guidance (Annex E), national/regional value recommendations (Annex F), packaging/storage/transportation and labelling requirements.

Applications and who uses this standard

Manufacturers and processors - ensure raw-material quality specifications for dried Rehmannia root.

Exporters / importers & distributors - compliance for international trade, product acceptance and grading.

Quality control and analytical laboratories - implement validated test methods for catalpol, rehmannioside D, ash, moisture, heavy metals and pesticide residues.

Regulators and standards bodies - reference for establishing national limits or inspection criteria.

Practitioners and supply-chain managers - assurance of authenticity, safety and consistency in Chinese materia medica.

Related standards

ISO 23723 - General requirements for herbal raw material and sampling

ISO 18664 - Determination of heavy metals in TCM herbal medicines

ISO 22258, ISO 22590, ISO 22217, ISO 21371, ISO 23193 - related methods for pesticide, sulfur dioxide, storage and labelling

ISO 9109:2024 provides a harmonized framework to support safety, authenticity and trade of Rehmannia glutinosa root in the global TCM market.

ISO 9109:2024 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses this standard

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 22217:2020

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

ISO 2137:1972

Petroleum products — Lubricating grease — Determination of cone penetration

ISO 23193:2020

Traditional Chinese medicine — Lycium barbarum and Lycium chinense fruit