ISO/FDIS 24825

ISO/TC 249/SC 1
Secretariat: SAC
Date: 2025-12-03
Traditional Chinese medicine — General principles for the
establishment of herbal reference substances
FDIS stage
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Contents
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
5 Establishment of herbal reference extracts . 3
5.1 Principle . 3
5.2 Items for establishment . 4
6 Establishment of herbal chemical reference substance . 5
6.1 Principle . 5
6.2 Items for establishment . 5
7 Quality control . 7
8 Report . 7
9 Instruction and labelling . 7
10 Packaging . 8
11 Storage and transportation . 8
Bibliography . 9

iii
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, SC1 Traditional
Chinese medicine.
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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 pharmacopoeia, European pharmacopoeia, Japanese
pharmacopoeia, Korean pharmacopoeia, and United States pharmacopoeia. InsightsAdditionally, this
document incorporates insights from ISO 17034, ISO Guide 30, ISO Guide 31 33401, ISO Guide 33, 33403 and
ISO Guide 35 are also incorporated 33405.
This document promotesseeks 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. Adherence to thisThis document aimsintends to ensure consistent quality and safe usage of
HMPs. ThisThe aim of this document is intended to help enterprises establish comprehensive production and
supply chain management systems, enhancing product safety and traceability. Moreover, this document
playsseeks to play a significant role in harmonizing the different requirements to overcome the barriers to
international trade, ensuringfostering the sustainable growth and positive reputation of the global HMPs
market.
It is important to note that thisThis document not only provides comprehensive guidance for herbal reference
substances but alsoand encourages ongoing research, innovation, and collaboration among stakeholders to
continuously improve iteratively refine the quality standards in the fieldcontrol and evaluation of herbal
medicinemedicines.
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DRAFT International Standard ISO/FDIS 24825:2025(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
terms and definitions, 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 17034, General requirements for the competence of reference material producers
ISO Guide 3533405, Reference materials — Guidance — Approaches for characterization and assessment of
homogeneity and stability
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
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 standardsstandard 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 isare well established. HerbalThe
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 - Term and — The definition has been revised and noteNote 1
to entry has been removed.]
3.6
homogeneity
state in which one or more properties of a reference substance have the same composition or structure
[SOURCE: ISO Guide 30:2015, 2.1.12, modified - Term and definition revised and notes to entry removed.]
4 Establishment of herbal reference material
4.1 Principle
The establishment of herbal reference materials includes: requirements offor raw materials, preparation of
herbal reference materials, homogenization and assessment of homogeneity, tests, identification, assay or
purity determination, and an assessment of stability. In addition, more information such as analytical results
obtained based on the requirements of national and regional pharmacopoeias (like ChP, EP, JP, KP, USP and
others) should be made available. by the manufacturer.
4.2 Items for establishment
4.2.1 Requirements of raw materials
The raw materials should be herbs of the right species or subspecies and the right herbal parts, which should
be clearly defined in phyto-taxonomy.
Information on raw materials shall be included as follows:
a) collection: including specimen photographs of raw plants, harvest time, growing year and region, and
cultivated or wild;
b) origin identification: including identification of botany and DNA;
c) part selection: including selected parts, cleaning, cutting, and drying;
d) storage: including storage conditions, and packaging form;
e) quality evaluation.
4.2.2 Preparation of herbal reference materials
Herbal reference materials generally should be made by equipment and methods selected according to the
characteristics of the individual raw material. Some raw materials need tocan be pre-treated to ensure the
homogeneity and keep the original constituents to the maximum extent.
4.2.3 Homogenization and assessment of homogeneity
If necessary, measuresMeasures of the produced batches should be taken for homogenization. Commonly used
homogenization methods include crushing, mixing, and sieving.
A homogeneity test should be completed before qualification by testing, identification, assay and value
assignment. Requirements for homogeneity assessment according to, in accordance with ISO Guide 35 33405,
shall apply.
4.2.4 Tests
According to the properties of herbal reference materials, the corresponding test items and the necessary
limits should be stipulated based on the test results of appropriate numbers of batches of samples.
4.2.5 Identification
Appropriate identification methods should be selected according to the properties of herbal reference
materials, and thevalidated for specificity and reproducibility of the methods should be paid attention to.
The identification items should include, but are not limited to, macroscopic identification, microscopic
identification, physicochemical identificati
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