ISO 5076:2024

Overview

ISO 5076:2024 - Traditional Chinese medicine - Angelica dahurica root defines quality and safety requirements for Angelica dahurica root (dried root of Angelica dahurica) used as natural medicine in international trade. The standard covers whole Chinese materia medica and decoction pieces, specifying morphological description, compositional markers, limits for impurities, and required test/reporting and handling practices to ensure product consistency and consumer safety.

Key topics and technical requirements

• Scope & description: Applies to dried Angelica dahurica root (commonly called baizhi) including size and appearance characteristics (roots typically 10–25 cm long, 1.5–2.5 cm diameter; greyish- to yellowish-brown surface; aromatic odor, pungent/slightly bitter taste).
• Morphology & macroscopic ID: Visual, smell and taste inspection for physical integrity, absence of mould, live insects and foreign matter.
• Chemical & analytical identification:
  • Thin-layer chromatogram (TLC) identification to match reference spots.
  • Marker compound determination (e.g., imperatorin, C16H14O4) to confirm chemical identity and potency.
• Quality limits:
  • Total ash content ≤ 7.0% (mass fraction).
  • Dilute ethanol (50%)‑soluble extractives ≥ 15.0% when measured.
  • Moisture, acid-insoluble ash, and other extractable contents to be determined.
• Contaminants:
  • Determination of heavy metals (arsenic, mercury, lead, cadmium).
  • Determination of pesticide residues.
• Sampling & test methods: Sampling per ISO 23723; test methods reference ISO 23723, ISO 18664 (heavy metals), ISO 22258 (pesticides), and specific annexes for TLC and marker assays.
• Reporting & labelling: Test report must identify sample, methods, results and anomalies. Packaging, storage and transport must prevent contamination and odor transfer; labelling follows ISO 21371.

Applications and who uses it

• Herbal raw material producers and processors - to meet international quality and safety expectations for exports.
• Pharmaceutical and nutraceutical manufacturers - for ingredient specification, batch release and supplier qualification.
• Analytical laboratories and quality-control units - to perform TLC, marker assays and contaminant testing following standardized methods.
• Regulators, importers and customs authorities - for conformity assessment, risk management and harmonized inspection criteria.
• Traditional Chinese medicine practitioners and wholesalers - to ensure consistent therapeutic raw material quality in global trade.

Related standards

• ISO 23723 - General requirements for herbal raw material and materia medica
• ISO 18664 - Determination of heavy metals in TCM herbal medicines
• ISO 22258 - Determination of pesticide residues by gas chromatography
• ISO 22217 - Storage requirements for raw materials and decoction pieces
• ISO 21371 - Labelling requirements for TCM products

Keywords: ISO 5076:2024, Angelica dahurica root, Traditional Chinese medicine, TLC identification, imperatorin, heavy metals, pesticide residues, herbal quality standard, international trade.