ISO/FDIS 21315

ISO/TC 249/SC 1/WG 1
Secretariat: SAC
Date: 2025-09-2311-06
Traditional Chinese medicine — Ganoderma lucidum fruiting body
Médecine traditionnelle chinoise — Organe fructifère de Ganoderma lucidum
FDIS stage
ISO/DISFDIS 21315:2025(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 Quality and safety requirements and recommendations . 2
5.1 General characteristics . 2
5.2 Morphological features . 3
5.3 Identification . 3
5.4 Moisture . 3
5.5 Total ash . 3
5.6 Water-soluble extractives . 3
5.7 Marker compounds . 3
5.8 Heavy metals . 3
5.9 Pesticide residues . 3
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification . 4
7.2 Identification . 4
7.3 Determination of moisture . 4
7.4 Determination of total ash . 4
7.5 Determination of water-soluble extractives . 4
7.6 Determination of marker compounds . 4
7.7 Determination of heavy metals . 4
7.8 Determination of pesticide residues . 4
8 Test report . 4
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatography (TLC) identification . 6
Annex B (informative) Determination of polysaccharides . 9
Annex C (informative) Determination of ganoderic acid A . 11
Annex D (informative) Reference information of national and regional requirements . 16
Bibliography . 17

iii
ISO/DISFDIS 21315:2025(en)
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
Traditional Chinese medicine.
This second edition cancels and replaces the first edition (ISO 21315:2018), which has been technically
revised.
The main changes are as follows:
— — added a note to entry in 3.13.1 to elucidate the correct name for the widely cultivated medicinal fungus
Ganoderma lucidum in China;
— — revised the recommendation for the moisture from “should not be more than 17,0 %” to “should be
determined” in 5.45.4;;
— — revised the recommendation for the water-soluble extractives from “should not be less than 3,0 %” to
“should be determined” in 5.65.6;;
— — added the principle of the test method, a table of relative retention time and correction factor of
ganoderic acids in Annex CAnnex C;;
— — updated the edition dates and requirements of the Chinese Pharmacopoeia, the United States
Pharmacopoeia and the Korean Herbal Pharmacopoeia, and added the requirements from the European
Pharmacopoeia in Annex DAnnex E.
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
Ganoderma lucidum fruiting body is the dried fruiting body of Ganoderma lucidum (Leyss. ex Fr.) Karst., which
is also known as Lingzhi or Reishi. It has been used as a medicinal mushroom in many Asian countries for
more than 20002 000 years, such as China, Japan and the Republic of Korea. This fungus can tonify Qi, and is
used to treat fatigue, cough and insomnia in traditional Chinese medicine. Modern pharmacological studies
also demonstrate its great potential in tumour treatment and immuno-enhancement. The market of
Ganoderma lucidum has developed rapidly, with increases in yield, production output and trade volume.
However, there remain many challenges, such as adulteration of similar species and lack of suitable testing
methods for quality assessment. Though Ganoderma lucidum has been recorded in several pharmacopoeias,
[ [1]] [ [2]]
such as Chinese Pharmacopoeia 1, , the Korean Herbal Pharmacopoeia 2, , the European
[ [3]] [ [4]]
Pharmacopoeia 3, , and the United States Pharmacopoeia 4, , the specifications and quality requirements
in these standards vary. Therefore, there is a clear and urgent need to develop an International Standard for
harmonizing the existing standards, as well as ensuring the safety and effectiveness of Ganoderma lucidum
fruiting body.
As national implementation can differ, national standards bodies are invited to modify the values given in
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 21315:2025(en)

Traditional Chinese medicine — Ganoderma lucidum fruiting body
1 Scope
This document specifies minimum requirements and test methods for Ganoderma lucidum fruiting body that
is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst.
It is applicable to Ganoderma lucidum fruiting body that is sold and used as Chinese materia medica (whole
medicinal materials) and decoction pieces derived from this fungus.
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 19609--2, Traditional Chinese medicine — Quality and safety of raw materials and finished products made
with raw materials — Part 2: Identity testing of constituents of herbal origin
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 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
Ganoderma lucidum fruiting body
dried sporocarp of Ganoderma lucidum (Leyss. ex Fr.) Karst.
Note 1 to entry: Based on recent taxonomic research, the correct name for the widely cultivated medicinal fungus
[ [5]]
Ganoderma lucidum in China is Ganoderma lingzhi Sheng H.Wu, Y.Cao & Y.C.Dai 5 (= Ganoderma sichuanense J.D.Zhao
[ [6] ]
& X.Q. Zhang 6 ). ).
3.2 3.2
marker compound
chemical constituent within a medicinal herb that can be used to verify its quality
3.3 3.3
reference substance
authentic substance used as a measurement base for TLC identification or marker compound quantification
4 Descriptions
Ganoderma lucidum fruiting body is the dried fruiting body of Ganoderma lucidum (Leyss. ex Fr.) Karst. in the
family of Ganodermataceae shown in Figure 1Figure 1.

a) Fruiting body of Ganoderma lucidum b) Vertical section of Ganoderma lucidum
Key
1 pileus
2 stipe
3 tubular pores
4 spore
Figure 1 — Structure of Ganoderma lucidum
5 Quality and safety requirements and recommendations
5.1 General characteristics
The following requirements shall be met before sampling.
a) a) Ganoderma lucidum fruiting body shall be clean and free from foreign matter.
b) b) The presence of living insects, moulds and external contaminants which are visible to the
naked eye shall not be permitted.
5.2 Morphological features
a) a) The fruiting body is umbrella-shaped in outline. The pileus is reniform, semi-rounded or
suborbicular, with a diameter ranging from 10 cm to 30 cm and a thickness from 1 cm to 4 cm.
b) b) The colour of the pileus varies, ranging from yellowish-brown to reddish-brown, with a
lustrous appearance. It features circular stripes and radiating wrinkles.
c) c) The stipe is cylindrical, typically ranging in length from 4 cm to 15 cm and in diameter from
1 cm to 3,5 cm. It exhibits a reddish-brown hue with a luminous quality. The attachment of the stipe to
the pileus can vary, ranging from lateral to nearly central.
d) d) The spores are small and fine, displaying a yellowish-brown colour.
e) e) The odour is slightly aromatic, with a taste that is slightly bitter.
5.3 Identification
5.3.1 Thin-layer chromatography (TLC) identification
When thin-layer chromatography (TLC) is performed for the identification of Ganoderma lucidum fruiting
body, the thin-layer chromatogram should present the spots or bands with the same colour and position
corresponding to those of reference solution.
5.3.2 High performance liquid chromatography (HPLC) identification
When TLC bands are not clearly identified, HPLC identification can be applied. The chromatogram of the test
solution should exhibit characteristic peaks (such as ganoderic acid A), corresponding in the retention times
to those in chromatogram of the reference solution.
5.4 Moisture
The mass fraction of moisture should be determined.
5.5 Total ash
The mass fraction of total ash should not be more than 4,0 %.
5.6 Water-soluble extractives
The mass fraction of water-soluble extractives should be determined.
5.7 Marker compounds
The mass fractions of marker compounds such as polysaccharides and ganoderic acid A should be determined.
5.8 Heavy metals
The mass fractions of heavy metals such as arsenic, cadmium, lead and mercury should be determined.
5.9 Pesticide residues
The mass fractions of pesticide residues should
...