Overview
ISO 24900:2026 delineates internationally recognized minimum requirements and standardized test methods for Sophora tonkinensis root and rhizome, which are widely used in Traditional Chinese Medicine (TCM). This standard covers both the whole medicinal materials and decoction pieces derived from Sophora tonkinensis, commonly known as “Shandougen.” It aims to ensure the quality, safety, and efficacy of these herbal materials through comprehensive testing, identification, and clear labelling. The document serves manufacturers, traders, and regulatory bodies involved in the production, distribution, and quality control of herbal medicines, particularly where international trade is concerned.
Key Topics
Major elements addressed in ISO 24900:2026 include:
- General and Morphological Requirements: Definitions, macroscopic and microscopic identification of Sophora tonkinensis root and rhizome to prevent adulteration and ensure authenticity.
- Quality Specifications:
- Cleanliness, exclusion of non-medicinal parts and contaminants
- Morphological features: root and rhizome structure, texture, and color
- Chemical Characteristics:
- Moisture content (mass fraction not exceeding prescribed percentages)
- Total ash content and ethanol-soluble extractives
- Quantification of marker compounds such as matrine and oxymatrine through advanced chromatographic methods
- Contaminant Controls:
- Determination of heavy metals and pesticide residues according to referenced ISO methods
- Testing Protocols:
- Detailed procedures for sampling, TLC (Thin-Layer Chromatography) identification, HPLC (High-Performance Liquid Chromatography) for marker compounds
- Packaging, Storage, and Labelling:
- Requirements to prevent contamination and preserve quality during storage and transportation
- Mandatory labelling information including origin, batch information, and storage instructions
Applications
ISO 24900:2026 is essential for:
- Quality Assurance in Herbal Medicine:
Ensures consistent quality and safety of Sophora tonkinensis root and rhizome in medicinal products and traditional remedies worldwide.
- Supply Chain Integrity:
Provides a basis for procurement, processing, and trading of authenticated and tested herbal materials, minimizing the risk of adulteration and substitution.
- Product Development and Regulatory Compliance:
Used by herbal product manufacturers and pharmaceutical companies to demonstrate regulatory compliance and facilitate international market access for TCM products.
- Healthcare and Clinical Use:
Supports clinicians and pharmacologists who require root and rhizome materials with known content of active and potentially toxic constituents.
- Research and Standardization:
Enables researchers to reference consistent quality metrics when investigating the pharmacological properties and safety of Sophora tonkinensis.
Related Standards
Several ISO standards complement ISO 24900:2026 in the field of traditional Chinese medicine and herbal medicines:
- ISO 18664: Determination of heavy metals in herbal medicines used in Traditional Chinese Medicine
- ISO/TS 21310: Microscopic examination of medicinal herbs
- ISO 21371: Labelling requirements for herbal medicinal products
- ISO 22217: Storage requirements for raw materials and decoction pieces in Traditional Chinese Medicine
- ISO 22258: Determination of pesticide residues by gas chromatography
- ISO 23723: General requirements for herbal raw material and materia medica
Implementing ISO 24900:2026 alongside these related standards establishes a comprehensive framework for the safety, quality, and traceability of herbal medicines, promoting confidence among consumers, regulators, and trading partners globally.
Keywords: ISO 24900, Sophora tonkinensis, root and rhizome, traditional Chinese medicine, herbal medicine standards, quality control, test methods, marker compounds, heavy metals, pesticide residues, TCM international trade.
