Overview
ISO 23972:2021 - Traditional Chinese medicine: Zingiber officinale rhizome defines quality and safety requirements and standard test methods for the dried rhizome of Zingiber officinale Roscoe when sold and used as a natural medicine (Chinese materia medica and decoction pieces) in international trade. It is explicitly not applicable to ginger sold or used as food or spices.
This international standard harmonizes identification, compositional limits and analytical procedures to support reliable quality control, regulatory compliance and cross-border trade of medicinal ginger.
Key topics and technical requirements
- Identification and description
- Macroscopic and microscopic features (morphology, starch granules, oil cells, vessels).
- Thin-layer chromatography (TLC) identification against reference solution.
- Quantitative limits
- Moisture: mass fraction ≤ 12.0%
- Total ash: mass fraction ≤ 8.0%
- Volatile oil: mass fraction ≥ 0.8%
- Marker compound (6‑gingerol): mass fraction ≥ 0.6%
- Water‑soluble extractives: mass fraction ≥ 10.0%
- Safety testing
- Determination of heavy metals (As, Hg, Pb, Cd)
- Pesticide residue analysis (per ISO 22258)
- Residue of sulfur dioxide
- Sampling, test methods and reporting
- Sampling guidance follows WHO recommendations for herbal materials.
- Test methods listed: macroscopic/microscopic ID, TLC, moisture, ash, volatile oil (hydrodistillation), 6‑gingerol assay, extractives, heavy metals, pesticides, sulfur dioxide.
- Includes requirements for test reports, packaging, storage, marking and labelling.
Applications and who uses it
ISO 23972:2021 is intended for organizations and stakeholders involved in the production, testing and international trade of medicinal ginger:
- Manufacturers of traditional Chinese medicine (TCM) raw materials and decoction pieces
- Quality control and analytical laboratories performing TLC, volatile oil, 6‑gingerol and contaminant testing
- Regulatory authorities and pharmacopoeia committees harmonizing medicinal herb standards
- Exporters/importers and traders needing a recognized specification for compliance and traceability
- Procurement and supply‑chain managers ensuring batch acceptance criteria
Practical benefits include consistent product identity, measurable assay specifications (e.g., 6‑gingerol, volatile oil), and harmonized safety testing to facilitate international market access for medicinal Zingiber officinale rhizome.
Related standards
Relevant normative references and related standards cited in ISO 23972:2021:
- ISO 1003 (Ginger - spices specification)
- ISO 6571 (volatile oil determination)
- ISO 18664 (heavy metals in TCM)
- ISO/TS 21310 (microscopic examination)
- ISO 21371 (labelling requirements)
- ISO 22258 (pesticide residues)
- ISO 22590 (sulfur dioxide determination)
- World Health Organization - Quality control methods for herbal materials
Keywords: ISO 23972:2021, Zingiber officinale rhizome, traditional Chinese medicine, 6‑gingerol, volatile oil, moisture content, TLC identification, herbal quality standard.