Overview
ISO 22584:2019 - Traditional Chinese medicine - Angelica sinensis root defines minimum requirements and test methods for Angelica sinensis root (Oliv.) Diels used as a natural medicine in international trade. The standard covers whole Chinese materia medica and decoction pieces, providing standardized quality criteria, identification methods and laboratory tests to support safety, efficacy and traceability of this widely used herbal ingredient.
Key Topics and Requirements
- Scope and applicability: Applies to Angelica sinensis root sold and used as a medicinal herbal material in international trade, including sampling and testing for commercial batches.
- Morphology & organoleptics: Describes macroscopic features (root stock (“Angelica head”), main root, branching roots), texture, colour, aroma and taste to support macroscopic identification.
- Identification methods:
- Macroscopic identification (samples ≥ 500 g per batch).
- TLC identification (thin-layer chromatography) - see Annex A.
- Quantitative quality limits:
- Moisture: mass fraction ≤ 15.0%.
- Total ash: mass fraction ≤ 7.0%.
- Acid‑insoluble ash: mass fraction ≤ 2.0%.
- 70% ethanol-soluble extractives: mass fraction ≥ 40.0%.
- Marker compound (example: ferulic acid): ferulic acid ≥ 0.050% (mass fraction); determination procedures in Annex C.
- Contaminants and residues:
- Heavy metals: arsenic, mercury, lead, cadmium - limits to follow regulatory requirements or pharmacopoeial values (ISO 18664 referenced).
- Pesticide residues: examples include benzex, DDT and quintozene - analysis per CODEX STAN 229 and CAC/MRL01.
- Testing & reporting: Specifies test methods (referencing ISO 1575, 1577, ISO 20409, ISO 18664) and required test report content (sample ID, methods used, results, anomalies, dates).
- Handling: Includes requirements for sampling, packaging, storage, transportation and labelling to maintain quality.
Applications and Who Uses It
ISO 22584:2019 is intended for:
- Herbal raw-material producers and farmers seeking standardized quality criteria.
- Quality control and analytical laboratories performing TLC, moisture, ash, extractives, ferulic acid, heavy metal and pesticide testing.
- Herbal product manufacturers, exporters/importers and distributors ensuring compliance for international trade.
- Regulatory bodies and pharmacopoeia authors aligning national requirements with international practice.
- R&D and formulation teams in pharmaceutical and cosmetic sectors using Angelica sinensis root.
Related Standards
Key referenced documents include:
ISO 22584:2019 supports consistent quality control, safety, and international trade of Angelica sinensis root by harmonizing identification and testing practices for this important Traditional Chinese Medicine ingredient.