ISO 24049:2025

Overview

ISO 24049:2025 - Traditional Chinese medicine - Aconitum carmichaelii parent root tuber provides an international quality-control framework for the dried parent root tuber of Aconitum carmichaelii (Aconiti Radix, Chuanwu). It specifies minimum requirements and test methods for material sold and used as natural medicines in international trade (whole medicinal materials and decoction pieces). Processing methods and processed products are excluded.

Key topics and requirements

• Scope and definitions: Applies to unprocessed dried parent root tuber used as herbal medicine; defines botanical identity and collection/drying practices.
• Identity and description: Macroscopic (shape, size, colour, fracture, texture) and microscopic characteristics (transverse section, powder features) for botanical verification.
• Chemical markers: Uses aconitine, mesaconitine and hypaconitine as principal marker compounds; includes provisions for marker-compound testing to assess potency and safety.
• Safety tests and limits: Requirements and test methods for moisture, total ash, acid‑insoluble ash, heavy metals and pesticide residues to ensure product safety and quality.
• Analytical methods:
  • Thin-layer chromatography (TLC) identification (Annex A informative)
  • Reference to HPLC methods for Aconitum alkaloids (ISO 23191)
  • Protocols for microscopic and macroscopic examination, moisture and ash determinations
• Sampling and test reporting: Procedures for representative sampling, required test-report content and documentation of results.
• Packaging, storage, labelling: Requirements to preserve quality during storage and transportation; labelling according to relevant TCM labelling rules.
• Regional flexibility: National bodies may adapt numeric values for limits (moisture, ash, marker compounds, heavy metals); Annex B gives examples of national/regional values.

Applications and users

ISO 24049:2025 is intended for practical use by:

• Manufacturers and suppliers of Chinese materia medica to ensure raw-material quality and compliance for international trade.
• Analytical and quality-control laboratories conducting identity and safety testing (TLC, HPLC, heavy metals, pesticide residue assays).
• Regulators and customs authorities setting import/export controls and safety criteria for Aconitum products.
• Traditional Chinese medicine practitioners and distributors who require standardized quality assurance for clinical safety.
• Standards bodies and harmonization initiatives working to align national regulations for toxic Aconitum alkaloids.

Related standards

Key referenced standards include:

• ISO 23191 (HPLC determination of selected Aconitum alkaloids)
• ISO 18664 (heavy metals in TCM)
• ISO 22258 (pesticide residues by GC)
• ISO/TS 21310 (microscopic examination)
• ISO 21371 (labelling), ISO 22217 (storage), ISO 23723 (general herbal raw material requirements)

ISO 24049:2025 supports safer, harmonized quality control for Aconitum carmichaelii in international trade by combining botanical, chemical and safety testing requirements.