ISO/FDIS 25003

ISO/TC 249/SC1/WG1SC 1
Secretariat: SAC
Date: 2025-08-10-27
Traditional Chinese medicine — Gentiana scabra, Gentiana
manshurica, and Gentiana triflora root and rhizome
FDIS stage
ISO #####-#:####(X/FDIS 25003:2025(en)
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© ISO #### 2025 – All rights reserved
ii
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements and recommendations . 3
5.1 Morphological features . 3
5.2 Microscopic identification . 3
5.3 Moisture . 6
5.4 Total ash . 6
5.5 Acid-insoluble ash . 6
5.6 Water-soluble extractives . 6
5.7 Thin-layer chromatogram identification . 6
5.8 Marker compound . 6
5.9 Heavy metals . 6
5.10 Pesticide residues . 6
5.11 Sulfur dioxide . 6
6 Sampling . 6
7 Test methods . 6
7.1 Macroscopic identification . 6
7.2 Microscopic identification . 6
7.3 Determination of moisture content . 7
7.4 Determination of total ash content . 7
7.5 Determination of acid-insoluble ash content . 7
7.6 Determination of water-soluble extractives content . 7
7.7 Thin-layer chromatogram identification . 7
7.8 Determination of marker compound . 7
7.9 Determination of heavy metals content . 7
7.10 Determination of pesticide residues content . 7
7.11 Determination of sulfur dioxide contents . 7
8 Test report . 7
9 Packaging, storage and transportation . 8
10 Marking and labelling . 8
Annex A (informative) Determination of water-soluble extractives . 9
Annex B (informative) Thin-layer chromatogram identification . 10
Annex C (informative) Determination of gentiopicroside by HPLC-UV . 12
Annex D (informative) Referenced information of national and regional requirements . 15
Annex E (informative) Referenced information for differentiating Gentiana scabra Bunge,
Gentiana manshurica Kitagawa, and Gentiana triflora Palls . 17
Bibliography . 19

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ISO #####-#:####(X/FDIS 25003:2025(en)
Foreword
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bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
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This document was prepared by Technical Committee ISO/TC 249/SC1, , 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.
© ISO #### 2025 – All rights reserved
iv
Introduction
Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome is the dried root and rhizome
of Gentiana scabra Bunge, G. manshurica Kitagawa, and G. triflora Palls (Fam. Gentianaceae), which is known
as Longdan (龙胆 in Chinese) in China. Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and
rhizome is a commonly used Chinese herbal medicine with a long history and is documented in Divine
Farmer's Materia Medica.materia medica. It has a long history of medicinal use in East Asian countries and is
traditionally valued and reported to eliminate damp-heat and quench fire of the liver and gallbladder.
Clinically, Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome is applied in cases of
jaundice, prolonged erection, eczema accompanied with itching, bloodshot eyes, poor hearing, pain in the
costal regions and bitter taste in the mouth, convulsion, etc. There are about 500 preparations and formulae
containing Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome and there is a 10 %
increase in the demand for Gentiana root and rhizome in the Chinese materia medica market at home and
abroad, about 2, 400 tons per year.
In terms of quality supervision of medicinal materials, the quality and safety of Gentiana scabra, Gentiana
manshurica, and Gentiana triflora root and rhizome are regulated in the Pharmacopeia of the People's Republic
of China, Japanese Pharmacopoeia, Korean Pharmacopoeia and Hong Kong Chinese Materia Medica Standards.
However, the requirements are not all the same among these pharmacopoeias and standards. The standards
of Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome have not yet been unified at
the international level, leading to the supervision being different by the regulatory authorities in many
countries.
In addition, Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome is ranked 85th in
ISO/TR 23975:2025, which indicates its high priority. Therefore, it is necessary to establish an international
standard of Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome, which unifies the
quality and safety of Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome, ensures
the safety and effectiveness of the medication, and regulates trade in the international market.
This document aims to establish an international standard for Gentiana scabra, Gentiana manshurica, and
Gentiana triflora root and rhizome to guarantee the clinical effectiveness, safety, and controllability of this
valuable medicine in global commerce and trade.
As national implementation may differ, national standards bodies are invited to modify the values given in
5.45.4 and 5.55.5 in their national standards. Examples of national and regional values are given in
Annex DAnnex D.
v
FINAL DRAFT International Standard ISO/FDIS 25003:2025(en)

Traditional Chinese medicine — Gentiana scabra, Gentiana
manshurica, and Gentiana triflora root and rhizome
1 Scope
This document specifies the quality and safety requirements of Gentiana scabra, Gentiana manshurica, and
Gentiana triflora root and rhizome.
This document applies to Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome that
is sold and used as natural medicines in international trade, including in Chinese materia medica, in its whole
medicinal material, and in decoction pieces derived from these plants.
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 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration
ISO 23723:2021, 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
marker compound
chemical constituent within a medicinal herb that can be used to verify its quality
ISO #####-#:####(X/FDIS 25003:2025(en)
Note 1 to entry: Usually described as active ingredients or chemicals that confirm the correct botanical identity of the
starting material.
Note 2 to entry: There can be one or more marker compounds for a medicinal herb.
4 Descriptions
Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome is the dried root and rhizome
of Gentiana scabra Bunge, G. manshurica Kitagawa, and G. triflora Palls (see 0Figure 1)) collected in the spring
and autumn. Referenced information for differentiating the three species are given in Annex E.

B C
A
2 2
5 cm
Key
A plant of Gentiana scabra
Inserted Cells
Bunge
Ba) plant of Gentiana manshurica c)
Kitagawab)
C plant of Gentiana triflora Palls
1 aerial part
2 root and rhizome
Key
© ISO #### 2025 – All rights reserved
a plant of Gentiana scabra Bunge
b plant of Gentiana manshurica Kitagawa
c plant of Gentiana triflora Palls
1 aerial part
2 root and rhizome
Figure 1 — Structure of the plants of Gentiana scabra, Gentiana manshurica, and Gentiana triflora
root and rhizome
5 Requirements and recommendations
5.1 Morphological features
The rhizome is irregularly bundle-shaped, 1 cm to 3 cm long, 0,3 cm to 1 cm in diameter; the outer surface is
dark greyish-brown or dark brown; the upper part is with stem scars or remnants of stems, surroundings and
the lower part is bearing numerous slender roots. The root is cylindrical, slightly twisted, 4 cm to 20 cm long,
0,2 cm to 0,5 cm in diameter; the outer surface is pale yellow or yellowish-brown; the upper part is usually
with conspicuous transverse wrinkles, and the lower part is narrower and marked with longitudinal wrinkles
and rootlet scars. The texture is fragile, easily broken; broken surface is slightly even, bark yellowish-white or
yellowish-brown. The xylem is pale in colour. The odour is slight. The taste is very bitter.
5.2 Microscopic identification
5.2.1 Transverse section
The exodermis consists of a layer of cells, the outer walls are slightly thick. The cortex is narrow, often with
cleft. The exodermis is distinct, cells are elongated tangentially, and each cell is divided by longitudinal walls
into several subsquare small cells. The phloem is broad with cleft. The cambium is indistinct. In the xylem, 5
to 10 vessels form groups. The parenchyma cells contain minute needle crystals of calcium oxalate. The pith
is distinct. 0Figure 2 shows the transverse section.

1 mm
ISO #####-#:####(X/FDIS 25003:2025(en)

Key
1 exodermis
2 cortex
3 cleft
4 endodermis
5 phloem
6 xylem
7 sieve vessel
8 pith
1 exodermis
2 cortex
3 cleft
4 endodermis
5 phloem
6 xylem
7 sieve vessel
8 pith
Figure 2 — Microscopic characteristics of the transverse section of Gentiana scabra, Gentiana
manshurica, and Gentiana triflora root and rhizome
5.2.2 Powder
The powder is yellowish-brown. The exodermis cells are spindle-shaped in surface view, and each cell is
divided by transverse walls into several small flattened rectangular cells. The endodermis cells are sub-
rectangular in surface view and large. The periclinal walls show minute transverse striations, and each cell is
divided by longitudinal septa walls into several small palisade-like cells, mostly longitudinal septa beaded. The
parenchyma cells contain minute needle crystals of calcium oxalate. The reticulated and scalariform vessels
are up to about 45 μm in diameter. 0Figure 3 shows the microscopic characteristics of the powder.
© ISO #### 2025 – All rights reserved
50 m
Key
1 exodermis
2 endodermis
3 needles of calcium oxalate
4 vessel
1 exodermis
2 endodermis
3 needles of calcium oxalate
4 vessel
ISO #####-#:####(X/FDIS 25003:2025(en)
Figure 3 — Microscopic characteristics of the powder of Gentiana scabra, Gentiana manshurica, and
Gentiana triflora root and rhizome
5.3 Moisture
The mass fraction of moisture should be determined.
5.4 Total ash
The mass fraction of total ash should not be more than 7,5 %.
5.5 Acid-insoluble ash
The mass fraction of acid-i
...