ISO 24976

ISO/FDIS 24976:2025(en)
Date: 2025-07-28
ISO/TC 249/WG SC 1
Secretariat: SAC
Date:
Traditional Chinese medicine — Pueraria lobata root
FDIS stage
ISO/FDIS 24976:2025(en)
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Published in Switzerland
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ISO/FDIS 24976:2025(en)
Contents
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 1
5 Requirements . 4
5.1 General characteristics . 4
5.2 Macroscopic features . 4
5.3 Microscopic feature . 4
5.4 Thin-layer chromatography (TLC) features . 4
5.5 Characteristic fingerprint . 4
5.6 Marker compounds . 4
5.7 Ethanol-soluble extractive. 4
5.8 Total ash . 4
5.9 Acid-insoluble ash . 4
5.10 Moisture . 5
5.11 Foreign matter . 5
5.12 Heavy metals . 5
5.13 Pesticide residues . 5
5.14 Sulfur dioxide . 5
5.15 Aflatoxins . 5
6 Sampling . 5
7 Test methods . 5
7.1 Identification of macroscopic features . 5
7.2 Identification of microscopic features . 5
7.3 Identification of thin-layer chromatogram . 5
7.4 Determination of characteristic fingerprint . 5
7.5 Determination of marker compounds . 5
7.6 Determination of ethanol-soluble extractive . 5
7.7 Determination of total ash . 6
7.8 Determination of Acid-insoluble ash . 6
7.9 Determination of moisture . 6
7.10 Determination of foreign matter . 6
7.11 Determination of heavy metals . 6
7.12 Determination of pesticide residues . 6
7.13 Determination of sulfur dioxide . 6
7.14 Determination of aflatoxin . 6
8 Test report . 6
9 Marking and labelling . 6
10 Packaging, storage and transportation . 7
Annex A (informative) Identification of thin-layer chromatogram . 8
Annex B (informative) Determination of characteristic fingerprint of Pueraria lobata root . 10
Annex C (informative) Determination of puerarin . 15
Annex D (informative) Reference of national and regional requirements . 17
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ISO/FDIS 24976:2025(en)
Annex E (informative) Traditional classification of Pueraria lobata root for commercial trade . 19
Bibliography . 20

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ISO/FDIS 24976:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
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.

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ISO/FDIS 24976:2025(en)
Introduction
The medicinal history of Pueraria lobata root (Chinese Pinyin name: Ge Gen) dates back over 2 000 years.
Pueraria lobata root has been used as a traditional herbal medicine in China, Japan, South Korea, United
Kingdom and other countries. It has exhibited diverse therapeutic effects, such as antipyretic, hypolipidemic,
hypoglycemic and hypotensive, intended for the treatment of arrhythmia, myocardial ischemia, osteoporosis
etc.
The establishment of an international standard for Pueraria lobata root is necessary to guarantee the clinical
effectiveness, safety and controllability in global commerce and trade.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.65.6, 5.8, 5.8 and 5.105.10 in their national standards. Examples of national and regional values are given in
Annex DAnnex D. In addition, grading information of Pueraria lobata root are given in Annex EAnnex E.
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ISO/FDIS 24976:2025(en)
Traditional Chinese medicine — Pueraria lobata root
1 Scope
This document specifies the quality and safety requirements of Pueraria lobata root.
This document applies to Pueraria lobata root that is sold and used as natural medicine in international trade,
including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this root.
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 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO/TS 21310, Traditional Chinese medicine — Microscopic examination of medicinal herbs
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use
ISO 22217, Traditional Chinese medicine — Storage requirements for raw materials and decoction pieces
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
ISO 22283, Traditional Chinese medicine — Determination of aflatoxins in natural products by LC-FLD
ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration
ISO 23723, Traditional Chinese medicine — General requirements for herbal raw material and materia medica
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 3.1
Pueraria lobata root
dried root of Pueraria lobata (Willd.) Ohwi (Fam. Leguminosae) after primary processing
Note 1 to entry: Pueraria lobata root is harvested in autumn or winter. The primary processing includes washing, cutting
into small cubes or into thick slices when fresh, and drying in the sun or in the oven (usually below 60 °C).
4 Descriptions
Pueraria lobata root is the dried root of Pueraria lobata (Willd.) Ohwi. (Fam. Leguminosae) as shown in
Figure 1Figure 1.
ISO/FDIS 24976:2025(en)
a) inflorescence of Pueraria lobata b) leaf of Pueraria lobata c) root of Pueraria lobata

d) inner side of thick slice (Pueraria lobata root)
ISO/FDIS 24976:2025(en)
e) outer surface of thick slice (Pueraria lobata root)

g) microscopic features of root transverse section of
f) small cubes (Pueraria lobata root)
Pueraria lobata
Key
1 cork
2 fibre bundle
3 phloem
4 xylem ray
5 xylem
1 cork
2 fibre bundle
3 phloem
4 xylem ray
5 xylem
Figure 1 — Structure of Pueraria lobata root
ISO/FDIS 24976:2025(en)
5 Requirements
5.1 General characteristics
The following requirements shall be met before sampling:
a) a) the sample shall be clean and free from rootlets;
b) b) the presence of living insects, mouldy root and rhizome, and external contaminants which are
visible to the naked eye shall not be permitted.
5.2 Macroscopic features
5.2.1 5.2.1 Tuberous root, wholly cylindric-like and thick. Usually in thick, longitudinally cut slice, or in
small irregular cube, variable in size. Externally brown, with longitudinal wrinkles (Figure 1(Figure 1).).
5.2.2 5.2.2 Odourless. Taste slightly sweetish.
5.2.3 5.2.3 Transverse section rough, pale yellowish-brown, several concentric annular rings indistinctly
visible. Texture tough, pliable and strongly fibrous.
5.3 Microscopic feature
Examine the transverse section under a microscope. Fibre bundles multiple, associated with the vessels,
surrounded by parenchyma cells containing prisms of calcium oxalate, appearing as crystal fibres. Phloem and
xylem are arranged alternately as hetero-vascular bundles; vessels distinct, numerous, densely and alternately
arranged with fibre bundles, rays narrow, a few of starch granules in the parenchyma. See Figure 1Figure 1
g.).
5.4 Thin-layer chromatography (TLC) features
The identification of extract by thin-layer chromatography (TLC) shall present the spots or bands with the
same colour and position corresponding to those of reference solutions (see Figure A.1Figure A.1).).
5.5 Characteristic fingerprint
When HPLC fingerprinting is performed, characteristic peaks (see Figure B.1Figure B.1)) should be consistent
with the relative retention time range (see Table B.2Table B.2)) of the control fingerprint (reference
standard).
5.6 Marker compounds
The content of marker compound, such as puerarin, should be determined. The content of puerarin should not
be less than 2,0 %.
5.7 Ethanol-soluble extractive
The content of ethanol-soluble extractive should be determined.
5.8 Total ash
The content of total ash should not be more than 7,0 %.
5.9 Acid-insoluble ash
The content of acid-insoluble ash should be determined.
ISO/FDIS 24976:2025(en)
5.10 Moisture
The content of moisture in percentage mass should not be more than 14,0 %.
5.11 Foreign matter
The foreign matter rate should be determined.
5.12 Heavy metals
The contents of heavy metals such as arsenic, mercury, lead and cadmium shall be determined.
5.13 Pesticide residues
The contents of pesticide residues such as total DDT, dieldrin, total BHC (benzene hexachloride) and aldrin
should be determined.
5.14 Sulfur dioxide
The content of sulfur dioxide should be determined.
5.15 Aflatoxins
The contents of aflatoxin B1 and total aflatoxins (B1,
...