Overview
ISO 22585:2022 - Traditional Chinese medicine - Codonopsis pilosula root defines minimum requirements and test methods for Codonopsis pilosula (Franch.) Nannf. root used as Chinese materia medica (whole medicinal materials) and decoction pieces. The standard addresses botanical description, quality limits, identification methods and required analytical testing to ensure consistent safety and authenticity of Codonopsis pilosula root in international trade and manufacturing.
Key topics and technical requirements
- Morphological description: macroscopic appearance, colour, dimensions (10–35 cm length, 0.4–2.0 cm diameter at base), texture, odour and taste.
- Quantitative limits:
- Moisture: not more than 16.0%
- Total ash: not more than 5.0%
- Acid‑insoluble ash: not more than 2.0%
- Ethanol‑soluble extractives: ≥ 35.0%
- Identification and marker analysis:
- Thin‑layer chromatography (TLC) identification for marker compounds (e.g., lobetyolin) - matching spots/bands with reference solution.
- Determination of marker compound content (see Annex C for lobetyolin details).
- Contaminants and residues:
- Determination of heavy metals (arsenic, mercury, lead, cadmium).
- Pesticide residues and sulfur dioxide residues testing.
- Sampling and test methods:
- Documentation and handling:
- Test report requirements (sample ID, sampling method, test methods used, results, anomalies, test date).
- Packaging, storage and transportation, marking and labelling requirements.
Note: national bodies may adapt numeric limits (moisture, ash, extractives, marker content); Annex D provides referenced values for different regions.
Applications
- Quality control and acceptance criteria for suppliers, manufacturers and processors of Codonopsis pilosula root.
- Laboratory test protocols for analytical chemists and quality assurance teams in herbal medicine production.
- Regulatory and inspection guidance for authorities reviewing herbal imports/exports and labeling.
- Reference for procurement, storage and packaging specifications used by distributors and wholesalers.
Who should use this standard
- Herbal product manufacturers and formulators using Codonopsis pilosula root.
- Quality control and analytical laboratories handling TCM raw materials.
- National standards bodies and regulatory agencies.
- Importers/exporters, distributors and certification bodies in the Traditional Chinese medicine supply chain.
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