ISO 24825:2026

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
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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
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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
...