Overview
ISO/TS 25006:2025 - Traditional Chinese medicine - Sporoderm-broken Ganoderma lucidum spore powder is a technical specification that defines requirements and test methods for Ganoderma lucidum (Lingzhi/Reishi) spore powder after the spore wall (sporoderm) has been mechanically broken. The standard applies to sporoderm-broken Ganoderma lucidum spore powder sold and used as natural medicine or as a raw material for health products in international trade. It establishes quality, safety and identification measures to improve consistency, bioavailability and market confidence.
Key topics and requirements
- Identity and general characteristics: appearance (brown, loose powder), absence of visible contaminants, slight odour and weak/slightly bitter taste. Microscopic features include ovoid spores (6–11 µm × 4–7 µm) and broken tissue with few intact spores; no hyphae or starch grains observed.
- Chemical and analytical tests:
- HPLC identification: chromatogram must show characteristic peaks (for example glycerol trioleate) matching reference solution (see Annex A).
- Marker compounds: determination of polysaccharides and triterpenoids (polysaccharides methods in Annex D; triterpenoids by HPLC‑UV in Annex E).
- Peroxide value, moisture (≤ 9.0 %), total ash (≤ 3.0 %).
- Physical quality:
- Sporoderm-broken rate: not less than 95 % (determination method in Annex C).
- Contaminants and safety:
- Determination of aflatoxins B, microorganisms (total aerobic microbial count, yeasts and moulds, E. coli, Salmonella, bile‑tolerant gram‑negative bacteria), heavy metals (As, Cd, Pb, Hg), and pesticide residues.
- Sampling and test reporting: batch sampling (minimum sample 100 g) and standardized test report requirements.
- Packaging, storage, transportation, marking and labelling: requirements to support product integrity and compliance.
Applications and who uses it
ISO/TS 25006:2025 is intended for:
- Manufacturers and processors of sporoderm-broken Ganoderma lucidum spore powder
- Quality control and analytical laboratories performing HPLC, moisture, ash, microbiology and contaminant testing
- Regulatory authorities, importers/exporters and procurement teams assessing product compliance for traditional Chinese medicine and nutraceuticals
- Product developers and formulators who need consistent marker compound profiles (polysaccharides, triterpenoids) and validated sporoderm‑breaking performance
Adoption of ISO/TS 25006:2025 helps ensure product safety, improve bioavailability claims, and facilitate international trade of Ganoderma lucidum spore powder.
Related standards (if applicable)
- ISO 18664 - Determination of heavy metals in TCM herbal medicines
- ISO/TS 21310 - Microscopic examination of medicinal herbs
- ISO 21371 - Labelling requirements for oral/topical TCM products
- ISO 22258 - Determination of pesticide residues by GC
- ISO 22283 - Determination of aflatoxins in natural products by LC‑FLD
- ISO 22467 - Determination of microorganisms in natural products
- ISO 23723 - General requirements for herbal raw material and materia medica
Keywords: ISO/TS 25006:2025, Ganoderma lucidum spore powder, sporoderm-broken, Traditional Chinese medicine, HPLC identification, polysaccharides, triterpenoids, aflatoxins, microbiological limits, heavy metals, pesticide residues.