ISO 19025:2024 PDF

Name: ISO 19025:2024 — Traditional Chinese medicine — Glycyrrhiza uralensis, Glycyrrhiza inflata, and Glycyrrhiza glabra root and rhizome
SKU: ISO 19025:2024
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Traditional Chinese medicine — Glycyrrhiza uralensis, Glycyrrhiza inflata, and Glycyrrhiza glabra root and rhizome

Название (английский):

ISO 19025:2024

Traditional Chinese medicine — Glycyrrhiza uralensis, Glycyrrhiza inflata, and Glycyrrhiza glabra root and rhizome

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 15
Дата публикации:: 5 декабря 2024 г.
Издание:: ISO IS 19025 edition 1 version 1
ICS:: 11.120.10

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Описание (английский):

This document specifies the quality and safety requirements for Glycyrrhiza root and rhizome that is derived from the root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat or Glycyrrhiza glabra L. (Fam. Fabaceae). This document applies to Glycyrrhiza root and rhizome that is 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 19025:2024 - Traditional Chinese medicine - Glycyrrhiza uralensis, Glycyrrhiza inflata, and Glycyrrhiza glabra root and rhizome is the first-edition international standard (Dec 2024) that defines quality and safety requirements for licorice root and rhizome used as natural medicines in international trade. It applies to whole Chinese materia medica and decoction pieces derived from these Glycyrrhiza species and aims to harmonize quality, support clinical effectiveness, and protect public health.

Key topics and technical requirements

Species covered: Glycyrrhiza uralensis, Glycyrrhiza inflata, Glycyrrhiza glabra (and hybrids).

Physical and microscopic description: Macroscopic and microscopic identification criteria, morphological features and transverse‑section characteristics for species differentiation.

Quality limits:

Moisture ≤ 12.0%
Total ash ≤ 7.0%
Acid‑insoluble ash ≤ 2.0%

Chemical identity and markers: Thin‑layer chromatogram (TLC) identification and quantitative determination of marker compounds (e.g., glycyrrhizic acid and liquiritin). Annex B describes marker determination by HPLC‑UV.

Contaminants and residues: Mandatory testing for heavy metals (arsenic, mercury, lead, cadmium) and pesticide residues (e.g., organochlorine pesticides).

Sampling and test methods: Sampling according to ISO 23723 and macroscopic sample size requirements (test samples ≥ 250 g). Test methods include TLC, HPLC‑UV, and referenced ISO methods for heavy metals (ISO 18664) and pesticides (ISO 22258).

Packaging, storage, labelling: Requirements for storage, transportation, and labelling (see ISO 22217 and ISO 21371 referenced).

Practical applications - who uses this standard

Herbal product manufacturers - to establish incoming material specifications and batch release criteria for licorice root and rhizome.

Quality control laboratories - to adopt validated test methods (TLC, HPLC‑UV) and contaminant assays complying with international practice.

Regulators and customs authorities - to assess compliance of imported/exported Glycyrrhiza raw materials and decoction pieces.

Suppliers, distributors and exporters/importers - for consistent labelling, packaging, storage, and traceability in international trade.

Pharmacopoeia committees and research labs - as a reference for harmonizing monographs and comparative studies of Glycyrrhiza species.

Related standards and further guidance

ISO 23723:2021 - Sampling of herbal raw material and materia medica

ISO 18664 - Determination of heavy metals in TCM herbs

ISO 22258 - Determination of pesticide residues in natural products

ISO 22217 & ISO 21371 - Storage and labelling requirements for TCM raw materials and products

Keywords: ISO 19025:2024, licorice root standard, Glycyrrhiza quality, traditional Chinese medicine, glycyrrhizic acid, liquiritin, TLC, HPLC‑UV, heavy metals, pesticide residues.

ISO 19025:2024 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications - who uses this standard

Related standards and further guidance

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 22217:2020

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

ISO 2137:1972

Petroleum products — Lubricating grease — Determination of cone penetration