ISO 24825:2026

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

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.

Médecine traditionnelle chinoise — Principes généraux pour l'établissement de substances de référence à base de plantes médicinales

General Information

• Status: Published
• Publication Date: 26-Mar-2026
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 2 - Quality and safety of manufactured TCM products
• Current Stage: 6060 - International Standard published
• Start Date: 27-Mar-2026
• Due Date: 05-Feb-2027
• Completion Date: 27-Mar-2026

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.

Standards Content (Sample)

International
Standard
ISO 24825
First edition
Traditional Chinese medicine —
2026-03
General principles for the
establishment of herbal reference
substances
Médecine traditionnelle chinoise — Principes généraux pour
l'établissement de substances de référence à base de plantes
médicinales
Reference number
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Establishment of herbal reference material . 2
4.1 Principle .2
4.2 Items for establishment .2
4.2.1 Requirements of raw materials.2
4.2.2 Preparation of herbal reference materials .2
4.2.3 Homogenization and assessment of homogeneity.2
4.2.4 Tests .3
4.2.5 Identification .3
4.2.6 Assay or purity determination .3
4.2.7 Assessment of stability .3
5 Establishment of herbal reference extracts . 3
5.1 Principle .3
5.2 Items for establishment .3
5.2.1 Requirements of raw materials.3
5.2.2 Preparation of herbal reference extracts .3
5.2.3 Homogenization and assessment of homogeneity.4
5.2.4 Tests .4
5.2.5 Identification .4
5.2.6 Assay or purity determination .4
5.2.7 Assessment of stability .4
6 Establishment of herbal chemical reference substance . 4
6.1 Principle .4
6.2 Items for establishment .5
6.2.1 Requirements of raw materials.5
6.2.2 Preparation of herbal chemical reference substances .5
6.2.3 Homogenization and assessment of homogeneity.5
6.2.4 Tests .5
6.2.5 Identification .5
6.2.6 Assay or purity determination .6
6.2.7 Assessment of stability .6
7 Quality control . 6
8 Report . 6
9 Instruction and labelling . 7
10 Packaging. 7
11 Storage and transportation . 7
Bibliography . 8

iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
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with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
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Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, SC1 Traditional
Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
Introduction
The herbal reference substance serves as a benchmark for resolving disputes related to the quality of
herbal medicinal products (HMPs). This document outlines the principles for establishing herbal reference
substances, considering the requirements of Chinese, European, Japanese, Korean and United States
pharmacopoeia. Additionally, this document incorporates insights from ISO 17034, ISO Guide 30, ISO 33401,
ISO 33403 and ISO 33405.
This document seeks to promote confidence among manufacturers, regulators and consumers by providing
a common basis for evaluating and verifying the quality of HMPs. It ensures that the herbal reference
substances used in quality inspections and dispute resolutions meet recognized standards, enhancing
fairness and reliability. This document intends to ensure consistent quality and safe usage of HMPs. The aim
of this document is to help enterprises establish comprehensive production and supply chain management
systems, enhancing product safety and traceability. Moreover, this document seeks to play a significant role
in harmonizing the different requirements to overcome the barriers to international trade, fostering the
sustainable growth and positive reputation of the global HMPs market.
This document provides comprehensive guidance for herbal reference substances and encourages ongoing
research, innovation and collaboration among stakeholders to iteratively refine the quality control and
evaluation of herbal medicines.

v
vi
International Standard ISO 24825:2026(en)
Traditional Chinese medicine — General principles for the
establishment of herbal reference substances
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 3864-2, Graphical symbols — Safety colours and safety signs — Part 2: Design principles for product safety
labels
ISO 33405, Reference materials — Approaches for characterization and assessment of homogeneity and stability
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
herbal reference substance
substance that is derived from herbal medicinal plants and used as a reference standard in the
physicochemical tests for the identification and qualification of raw materials and finished products of
herbal medicines
Note 1 to entry: The physicochemical properties of an herbal reference substance are well established. The herbal
reference substance is divided into three types: herbal reference material, herbal reference extract and herbal
chemical reference substance.
3.2
herbal reference material
certified and homogeneous substance containing powdered herbal medicine with clear origin and
identification
3.3
herbal reference extract
certified and homogeneous substance containing a mixture of main effective ingredients or representative
ingredients and unknown chemical components that is prepared by extracting herbal medicine with a
specific process
3.4
herbal chemical reference substance
certified and homogeneous substance containing a single chemical component that is extracted, separated
and purified from herbal medicine
3.5
stability
characteristic of a reference substance, when stored under the specified time interval, packaging form and
storage conditions, to maintain its property values within a specified content or composition
[SOURCE: ISO Guide 30:2015, 2.1.15, modified — The definition has been revised and Note 1 to entry has
been removed.]
3.6
homogeneity
state in which one or more properties of a reference
...