Overview
ISO 23959:2021 - Traditional Chinese medicine - Glehnia littoralis root specifies international quality and safety requirements for Glehnia littoralis root (the dried or peeled root of Glehnia littoralis Fr. Schmidt ex Miq.). The standard applies to material sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces. Its purpose is to harmonize testing, reduce adulteration, and support safe cross-border trade of this TCM ingredient.
Key topics and technical requirements
- Morphology and identification
- General, macroscopic and microscopic descriptions (root shape, colour, transverse section and powder characteristics).
- Macroscopic metrics: length 9–45 cm, diameter 0.2–1.5 cm; distinctive fragrance and slightly sweet taste.
- Physicochemical limits
- Moisture: not more than 13.0%.
- Total ash: not more than 6.0%.
- Acid‑insoluble ash: not more than 1.5%.
- Chemical and analytical controls
- Marker compounds (e.g., falcarinol) and identification by thin‑layer chromatography (TLC).
- Procedures for determination of marker compounds, moisture, ash, and falcarinol (informative annexes included).
- Contaminant limits and safety
- Heavy metals (lead, arsenic, cadmium, mercury) requirements and test methods.
- Pesticide residues and sulfur dioxide residue testing.
- Sampling, test methods and reporting
- Standardized sampling, laboratory testing procedures, and test report content.
- Handling and labeling
- Packaging, storage and transportation guidance, plus labelling requirements for products intended for oral or topical use.
Practical applications and users
ISO 23959:2021 is practical for:
- Herbal product manufacturers and processors establishing raw-material specifications.
- Quality control and analytical laboratories performing TLC, heavy metals, pesticide and moisture assays.
- Importers/exporters and customs authorities ensuring compliance with international trade requirements.
- Regulatory bodies and pharmacopoeia committees harmonizing national standards.
- Supply chain managers and procurement teams verifying authenticity and reducing substitution or adulteration risks.
- Traditional Chinese medicine practitioners and formulary developers seeking consistent, safe materia medica.
Benefits include improved product consistency, clearer acceptance criteria in international trade, and reduced public‑health risk from contaminants.
Related standards
Normative references include ISO standards used for specific tests and handling, for example:
For implementation details, testing protocols, and national limit examples, consult the full ISO 23959:2021 document and relevant national standards bodies.
