Overview
ISO 13615:2024 - Traditional Chinese medicine - Atractylodes macrocephala rhizome establishes international quality, safety and testing requirements for the dried rhizome of Atractylodes macrocephala Koidz. It applies to whole medicinal materials and decoction pieces traded or used as natural medicine in international commerce. The standard harmonizes identification, sampling, analytical methods and handling to support safe, consistent supply and regulatory compliance for this widely used TCM herb.
Key topics and technical requirements
- Identification and description
- Macroscopic features (shape, size: about 3–13 cm long and 1.5–7 cm diameter, colour, fracture, oil cavities) and characteristics of decoction pieces are specified for visual inspection.
- TLC identification is required; HPLC identification (atractylenolide II, atractylenolide III and atractylon peaks) is used when TLC is inconclusive. Annex A and B give method guidance.
- Quality limits
- Moisture ≤ 15.0%
- Total ash ≤ 7.0%
- Presence and levels of sulfur dioxide residues, ethanol‑soluble extractives and essential oil content must be determined.
- Contaminant testing
- Determination of heavy metals (arsenic, cadmium, lead, mercury) and pesticide residues (e.g., BHC, DDT, quintozene) is required.
- Sampling and test methods
- Sampling follows ISO 23723; many test procedures reference ISO standards for heavy metals, pesticides, sulfur dioxide and moisture/ash determinations.
- Supply chain controls
- The standard includes requirements for sampling, test reporting, packaging, storage, transportation, marking and labelling to ensure product integrity in trade.
Applications and users
ISO 13615:2024 is practical for:
- Herbal manufacturers and processors producing Atractylodes macrocephala rhizome or decoction pieces.
- Quality control and analytical laboratories performing TLC, HPLC and contaminant testing.
- Exporters, importers and distributors ensuring compliance with international TCM quality and safety expectations.
- Regulatory authorities and purchasers seeking harmonized specifications for market surveillance and procurement.
- Farmers and value‑chain stakeholders aiming to meet export and pharmacopoeial requirements.
Practical benefits include harmonized testing protocols, clearer acceptance criteria for moisture and ash, and defined contaminant testing to reduce trade barriers and improve consumer safety for TCM products.
Related standards
Normative references used by ISO 13615:2024 include:
Keywords: ISO 13615:2024, Atractylodes macrocephala rhizome, traditional Chinese medicine, TCM quality standard, TLC identification, HPLC, moisture content, heavy metals, pesticide residues, decoction pieces.
