ISO 24825:2026

Name: ISO 24825:2026 — Traditional Chinese medicine — General principles for the establishment of herbal reference substances
SKU: ISO 24825:2026
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Traditional Chinese medicine — General principles for the establishment of herbal reference substances

Название (английский):

ISO 24825:2026

Traditional Chinese medicine — General principles for the establishment of herbal reference substances

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 8
Дата публикации:: 27 марта 2026 г.
Издание:: ISO IS 24825 edition 1 version 1
ICS:: 11.120.10

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Описание (английский):

This document specifies the general principles for the establishment of herbal reference substances, covering production, quality control, report, instruction and labelling, packaging, storage and transportation. This document applies to herbal reference substances that are sold and used as reference standards for the quality control of herbal medicines in international trade, including raw materials and finished products.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 24825:2026 sets out the general principles for establishing herbal reference substances used in Traditional Chinese Medicine (TCM). These substances are crucial for the quality control of herbal medicines in international trade, covering both raw materials and finished products. The standard provides uniform requirements for production, quality control, reporting, instructions and labelling, packaging, storage, and transportation of herbal reference substances, building confidence among manufacturers, regulators, and consumers in global herbal medicine markets.

Key Topics

Definitions and Types of Herbal Reference Substances

Herbal reference substance: Derived from medicinal plants and used as a standard for identification and quality testing.
Three main types: herbal reference material, herbal reference extract, and herbal chemical reference substance.

Establishment Principles

Requirements for sourcing authentic raw materials, with clear botanical identification.
Preparation protocols tailored to specific herb characteristics.
Homogenization to ensure consistent composition and structure across batches.
Testing procedures to determine essential criteria such as purity, moisture, ash, and solvent residues.
Identification methods validated for specificity and reproducibility, including macroscopic, microscopic, physicochemical, and biological approaches.
Stability testing to confirm long-term reliability and appropriate storage instructions.

Quality Control and Documentation

Implementation of quality management and traceability in line with best practices such as GMP and GLP.
Detailed reporting via certificates of analysis, specifying batch details, producer information, physical characteristics, and analytical values.
Labelling requirements include batch number, storage conditions, instructions, and hazard symbols where necessary.

Packaging, Storage, and Transportation

Use of packaging that preserves integrity, prevents contamination, and ensures stability according to the physical and chemical characteristics of the reference substance.
Clear guidelines on environmental controls during storage and transportation to maintain substance quality.

Applications

Quality Control in International Trade

Herbal reference substances are essential for quality inspection processes in global herbal medicine markets, enabling harmonized standards across borders.
Used to resolve disputes regarding authenticity and quality of herbal medicinal products (HMPs).

Standardization across Pharmacopeias

The principles align with major pharmacopoeias (Chinese, European, Japanese, Korean, US), promoting interoperability and acceptance.
Facilitate regulatory compliance and support the sustainable growth and international reputation of herbal medicinal products.

Production and Supply Chain Management

Provides manufacturers and suppliers with frameworks for consistent, traceable, and reliable production and distribution.
Supports proper documentation for audits, certification, and quality assurance processes.

Research and Innovation

Encourages continuous improvement of quality control methods and international collaboration among stakeholders in TCM and herbal medicine sectors.

Related Standards

Implementing ISO 24825:2026 is often accompanied by familiarization with the following related standards:

ISO 17034: General requirements for the competence of reference material producers

ISO Guide 30: Reference material-Selected terms and definitions

ISO 33401: Reference materials-Contents of certificates, labels, and accompanying documentation

ISO 33403: Reference materials-Requirements and recommendations for use

ISO 3864-2: Safety colours and safety signs-Design principles for product safety labels

ISO 33405: Approaches for characterization and assessment of homogeneity and stability

ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories

Adhering to ISO 24825:2026 helps unify quality control processes for TCM herbal products, creating a trustworthy framework for international commerce, regulatory compliance, and ongoing innovation in herbal medicine.

ISO 24825:2026

Abstract

Похожие стандарты

Overview

Key Topics

Applications

Related Standards

Технические детали

BS ISO 33401:2024

Reference materials. Contents of certificates, labels and accompanying documentation.

BS ISO 33403:2024

Reference materials. Requirements and recommendations for use.

ISO 3864-2:2016

Graphical symbols — Safety colours and safety signs — Part 2: Design principles for product safety labels

ISO 33405:2024

Reference materials — Approaches for characterization and assessment of homogeneity and stability

BS EN ISO/IEC 17025:2017

General requirements for the competence of testing and calibration laboratories.