Overview
ISO 24976:2026 is an international standard developed by ISO for the quality and safety requirements of Pueraria lobata root, a widely used herb in traditional Chinese medicine (TCM). Commonly known as “Ge Gen,” Pueraria lobata root is recognized in global trade as both a whole medicinal material (Chinese materia medica) and in the form of decoction pieces. This standard ensures that Pueraria lobata root meets defined criteria for international commerce, supporting clinical efficacy, consistency, and safety for use in natural medicine.
Key Topics
ISO 24976:2026 covers a comprehensive framework on:
- Definitions and descriptions: Identification of Pueraria lobata root, including its botanical origin, macroscopic and microscopic features, and traditional processing steps.
- Quality requirements: Specifies criteria such as purity, physical characteristics, and content of marker compounds (e.g., puerarin).
- Safety requirements: Details parameters for controlling heavy metals, pesticide residues, aflatoxins, sulfur dioxide, and moisture content.
- Testing and analysis: Includes methods for the sampling, identification, and quantification of active ingredients, as well as impurity limits using techniques like thin-layer chromatography (TLC) and high-performance liquid chromatography (HPLC).
- Labelling and documentation: Provides guidelines for package marking, labelling, and traceability in accordance with ISO standards.
- Packaging, storage, and transportation: Outlines criteria to prevent contamination and maintain product integrity during international distribution.
Applications
ISO 24976:2026 is highly relevant to stakeholders in the herbal medicine supply chain and international trade, including:
- Manufacturers and processors of Pueraria lobata root and its decoction pieces, supporting quality assurance and safety during production.
- Exporters and importers engaged in global trade of Pueraria lobata root, ensuring compliance with harmonized quality standards.
- Healthcare professionals and pharmacists, facilitating selection of reliable and standardized raw materials for herbal products.
- Regulatory authorities responsible for the control and registration of traditional Chinese medicinal products.
- Testing laboratories and quality control experts, enabling standardized methods for component analysis and impurity detection based on validated procedures.
- Procurement entities seeking consistent supply of high-grade medicinal plant materials for research or clinical use.
Benefits of implementation include:
- Improved product safety and quality for consumers.
- Simplification of international transactions through harmonized criteria.
- Traceability from harvest to market, enhancing confidence in supply chain integrity.
- Facilitation of regulatory compliance when exporting to markets with established pharmacopoeia requirements.
Related Standards
ISO 24976:2026 references and aligns with several related ISO and national standards to provide a complete quality and safety management system, including:
- ISO 18664 – Determination of heavy metals in herbal medicines used in TCM
- ISO/TS 21310 – Microscopic examination of medicinal herbs
- ISO 21371 – Labelling requirements for oral/topical TCM products
- ISO 22217 – Storage requirements for raw materials and decoction pieces
- ISO 22258 – Determination of pesticide residues in natural products
- ISO 22283 – Determination of aflatoxins in natural products by LC-FLD
- ISO 22590 – Determination of sulfur dioxide in natural products by titration
- ISO 23723 – General requirements for herbal raw material and materia medica
ISO 24976:2026 also provides references to major pharmacopoeias from China, Japan, Korea, the UK, and the European Union, helping harmonize requirements for Pueraria lobata root across different jurisdictions.
Keywords: Pueraria lobata root, Ge Gen, ISO 24976:2026, traditional Chinese medicine standard, herbal medicine quality, decoction pieces, herbal product safety, international trade, TCM quality control, herbal medicine testing.
