ISO/TS 25006:2025

Technical
Specification
ISO/TS 25006
First edition
Traditional Chinese medicine —
2025-07
Sporoderm-broken Ganoderma
lucidum spore powder
Médecine traditionnelle chinoise — Poudre de spores de
Ganoderma lucidum à sporoderme cassé
Reference number
© ISO 2025
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General characteristics .2
4.2 Microscopic features .2
4.3 High performance liquid chromatography (HPLC) identification.2
4.4 Moisture .2
4.5 Total ash .3
4.6 Peroxide value .3
4.7 Sporoderm-broken rate .3
4.8 Aflatoxins B .3
4.9 Marker compounds .3
4.10 Microorganisms .3
4.11 Heavy metals .3
4.12 Pesticide residues .3
5 Test methods . 3
5.1 General characteristics .3
5.2 Microscopic identification .3
5.3 High performance liquid chromatography (HPLC) identification.3
5.4 Determination of moisture content .3
5.5 Determination of total ash .3
5.6 Determination of peroxide value .4
5.7 Determination of sporoderm-broken rate .4
5.8 Determination of aflatoxins B .4
5.9 Determination of marker compounds .4
5.10 Determination of microorganisms .4
5.11 Determination of heavy metals .4
5.12 Determination of pesticide residues .4
6 Test report . 4
7 Packaging, storage and transportation . 4
8 Marking and labelling . 5
Annex A (informative) High performance liquid chromatography (HPLC) identification . 6
Annex B (informative) Determination of peroxide value . 8
Annex C (informative) Determination of sporoderm-broken rate . 9
Annex D (informative) Determination of polysaccharides content .10
Annex E (informative) Determination of the triterpenoids content by high performance liquid
chromatography - ultraviolet (HPLC-UV) .12
Annex F (informative) Reference information of national and regional requirements .15
Bibliography . 17

iii
Foreword
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Traditional Chinese medicine.
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iv
Introduction
Ganoderma lucidum spore is the reproduction unit of Ganoderma lucidum, which is also known as Lingzhi or
Reishi. The spore has a double-layered spore wall (sporoderm) mainly composed of chitin. The sporoderm
cannot be digested and degraded in the body, thus hindering the release and absorption of active components
such as polysaccharides and triterpenoids. Therefore, the sporoderm-breaking process is critical to
improving the effect and bioavailability of Ganoderma lucidum. Currently, the mainstream sporoderm-
breaking methods include extrusion, grinding, shearing, jet pulverization, etc., and mainly use equipment
such as vibration mills, homogenizers, and supersonic jet pulverizers.
Sporoderm-broken Ganoderma lucidum spore powder is gaining increasing acceptance and popularity as an
herbal medicine and a dietary ingredient, and possesses various bioactivities, including immunomodulation,
liver protection, and antitumor effects. The industry has developed rapidly and its market share has
gradually expanded. The yield of Ganoderma lucidum spore powder in China was about 10 000 t in 2020,
with a growth rate of 12,72 %, and the output value was 3,814 billion CNY, accounting for 47 % of the total
Ganoderma lucidum industry. In the international market, Japan, the Republic of Korea, USA, Malaysia and
other countries and regions have large-scale enterprises that produce and sell Ganoderma lucidum spore
powder products. According to incomplete statistics, the annual sales of Ganoderma lucidum and Ganoderma
lucidum spore powder related products exceed one billion USD.
However, quality standards of sporoderm-broken Ganoderma lucidum spore powder are lacking. At present,
there is no pharmacopoeia standard for the quality of sporoderm-broken Ganoderma lucidum spore powder.
Therefore, it is necessary to develop an International Standard to ensure the safety, effectiveness and quality
of sporoderm-broken Ganoderma lucidum spore powder and related products. This document promotes
sporoderm-broken Ganoderma lucidum spore powder and related products in the market by clarifying
the chemical composition and active components of Ganoderma lucidum spore powder through systematic
research.
As national implementation can differ, national standards bodies are invited to modify the values given in
4.4, 4.5 and 4.7 in their national standards. Examples of national and regional values are given in Annex F.

v
Technical Specification ISO/TS 25006:2025(en)
Traditional Chinese medicine — Sporoderm-broken
Ganoderma lucidum spore powder
1 Scope
This document specifies requirements and test methods for sporoderm-broken Ganoderma lucidum spore
powder that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst.
It is applicable to sporoderm-broken Ganoderma lucidum spore powder that is sold and used as natural
medicine and raw material for health products in international trade.
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 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 22467, Traditional Chinese medicine — Determination of microorganisms in natural products
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
Ganoderma lucidum spore
basidiospore ejected from the tube of Ganoderma lucidum (Leyss. ex Fr.) Karst. when mature
3.2
sporoderm-broken Ganoderma lucidum spore powder
powder of Ganoderma lucidum spore (3.1) produced by breaking the spore wall with physical methods such
as extrusion, milling, shearing, and jet pulverization

4 Requirements
4.1 General characteristics
The following requirements shall be met before sampling.
a) Sporoderm-broken Ganoderma lucidum spore powder shall be clean and free from foreign matter.
b) The presence of living insects, moulds and external contaminants (e.g. hyphae) which are visible to the
naked eye shall not be permitted.
c) The powder is brown, uniform in appearance, loose in texture, and free from agglomeration.
d) The powder has a slight odour and its taste is weak or slightly bitter.
4.2 Microscopic features
Microscopic features of Ganoderma lucidum spores and sporoderm-broken Ganoderma lucidum spore powder
are shown in Figure 1.
Ganoderma lucidum spores are brown, ovoid in shape, 6 µm to 11 µm long, 4 µm to 7 µm wide; the spore wall
is double-layered; the exospore is transparent and smooth; and the endospore is light brown or brown.
Sporoderm-broken Ganoderma lucidum spore powder is yellow-brown uniform broken tissue, with a limited
number of unbroken spores.
No hyphae and starch grains shall be observed.
a) Ganoderma lucidum spores b) Sporoderm-broken Ganoderma lucidum spore
powder
Figure 1 — Microscopic features of Ganoderma lucidum spore and sporoderm-broken Ganoderma
lucidum spore powder
4.3 High performance liquid chromatography (HPLC) identification
The chromatogram of the test solution should exhibit characteristic peaks (such as glycerol trioleate),
corresponding in the retention times to those in chromatogram of the reference solution.
4.4 Moisture
The mass fraction of moisture should not be more than 9,0 %.

4.5 Total ash
The mass fraction of total ash should not be more than 3,0 %.
4.6 Peroxide value
The peroxide value shall be determined.
4.7 Sporoderm-broken rate
The sporoderm-broken rate should not be less than 95 %.
4.8 Aflatoxins B
The content of aflatoxins B shall be determined.
4.9 Marker compounds
The contents of marker compounds, such as polysaccharides and triterpenoids, should be determined.
4.10 Microorganisms
The contents of microorganisms, such as total aerobic microbial count, total combined yeasts and moulds
count, Escherichia coli, bile-tolerant gram-negative bacteria, Salmonella, should be determined.
4.11 Heavy metals
The contents of heavy metals, such as arsenic, cadmium, lead and mercury, shall be determined.
4.12 Pesticide residues
The contents of pesticide residues shall be determined.
5 Test methods
5.1 General characteristics
Samples not less than 100 g are taken from each batch randomly. These samples are examined by the naked
eye, smelled, tasted and observed with a microscope.
5.2 Microscopic identification
The test method specified in ISO/TS 21310 shall apply.
5.3 High performance liquid chromatography (HPLC) identification
See Annex A for additional information.
5.4 Determination of moisture content
The test method specified in ISO 23723 shall apply.
5.5 Determination of
...