Overview
ISO 19047:2025 - Traditional Chinese Medicine - Polygonum multiflorum root is the first international standard that specifies quality, safety requirements and test methods for Polygonum multiflorum Thunb. root (commonly known as Heshouwu or Fallopia/Reynoutria multiflora). It applies to raw and processed Polygonum multiflorum root used as natural medicines and decoction pieces in international trade, providing harmonized criteria for manufacturers, testing laboratories, regulators and traders involved in herbal medicine and Chinese materia medica.
Key topics and technical requirements
ISO 19047:2025 defines both descriptive and analytical controls to support reliable quality control and safety evaluation:
- Identification and description
- Macroscopic morphology: shape (briquette/irregular spindle), external colour (reddish‑brown), dimensions (length 6–15 cm; diameter 4–12 cm), texture and fracture characteristics.
- Microscopic features: cork cell layers, phloem with 4–11 subrounded vascular bundles, starch granules (simple and compound, 4–50 µm), cluster calcium oxalate (10–80 µm, sometimes up to 160 µm), pitted annular vessels.
- Quality and safety assays
- Physicochemical tests: moisture content, total ash, water‑soluble extractives.
- Chemical identification: Thin‑layer chromatogram (TLC) profiling and marker compound determination (see Annex B for 2,3,5,4'‑tetrahydroxystilbene‑2‑O‑β‑D‑glucoside).
- Constituents: determination of total anthraquinone glycosides (Annex C).
- Contaminant limits and testing: heavy metals and pesticide residues with referenced test methods.
- Other requirements
- Sampling procedures, test reporting, packaging, storage, transportation, and labelling requirements for oral or topical use.
Practical applications and users
ISO 19047:2025 is designed for practical use across the supply chain:
- Quality control laboratories - adopt standardized test methods (TLC, moisture, ash, marker assays) to verify authenticity and batch quality.
- Manufacturers and processors - ensure raw and processed Polygonum multiflorum root meet international specifications for export and domestic distribution.
- Regulators and conformity assessors - use the standard to set or harmonize national requirements, monitor safety (heavy metals, pesticides) and reduce adulteration.
- Traders and importers/exporters - apply consistent acceptance criteria for Chinese materia medica and decoction pieces in international trade.
- Researchers and herbalists - reference diagnostic morphological and microscopic features and validated analytical methods.
Related standards and references
ISO 19047 cites and aligns with other ISO documents for methods and handling:
- ISO 18664 (heavy metals), ISO/TS 21310 (microscopy), ISO 21371 (labelling), ISO 22217 (storage), ISO 22258 (pesticide residues), and ISO 23723 (general herbal raw material requirements).
- Informative annexes (A–D) provide TLC identification guidance, marker compound and anthraquinone assay procedures, and national/regional reference values.
Keywords: ISO 19047:2025, Polygonum multiflorum, Heshouwu, Traditional Chinese Medicine, herbal medicine standard, quality control, TLC identification, marker compounds, heavy metals, pesticide residues, decoction pieces.