ISO 5106:2025

Overview

ISO 5106:2025 - Traditional Chinese medicine - Polygala tenuifolia and Polygala sibirica root is an international standard that specifies minimum quality, safety requirements and test methods for Polygala root used as natural medicine in international trade. The standard covers whole medicinal materials and decoction pieces, aiming to harmonize testing and reduce trade barriers for Polygala tenuifolia and Polygala sibirica root (commonly called Polygala root).

Keywords: ISO 5106:2025, Polygala tenuifolia, Polygala sibirica, Polygala root, TCM quality standard, herbal medicine testing.

Key topics and technical requirements

• Scope and definitions: Applies to dried roots sold and used as Chinese materia medica and decoction pieces; defines terms such as root, powder, total ash and marker compound.
• Description & morphology: Macroscopic features (e.g., P. tenuifolia roots typically 2–30 cm long and 0.2–1 cm diameter; pale greyish yellow–brown surface) and distinguishing differences between P. tenuifolia and P. sibirica (P. sibirica is more forked).
• Quality and safety criteria:
  • General characteristics: material must be dry; no visible insects, mould or external contaminants.
  • Macroscopic and microscopic identification (transverse sections and powder characteristics).
  • Chemical and contaminant checks: moisture, total ash, ethanol-soluble extractives, marker compound content, thin-layer chromatogram (TLC), mycotoxins (e.g., aflatoxins), heavy metals, pesticide residues, and sulfur dioxide residues.
• Sampling and test methods: Detailed sampling procedures and laboratory methods for macroscopic ID, TLC identification, moisture, ash, extractives, marker compounds and contaminant determinations are specified (see Annex A for TLC and Annex B for marker compound determination).
• Packaging, storage, transportation, marking and labelling: Requirements to preserve safety and traceability in trade.

Practical applications and who uses this standard

• Quality control laboratories: Implement prescribed test methods (TLC, moisture, ash, contaminants) to verify batch compliance.
• Manufacturers and processors of TCM products: Use the standard to set incoming raw-material specifications and supplier audits.
• Importers/exporters and traders: Harmonize acceptance criteria for international trade and avoid rejections due to inconsistent national limits.
• Regulators and pharmacopoeia committees: Reference ISO 5106:2025 when aligning national requirements and enforcement.
• Practitioners and formulators: Ensure raw-material authenticity and safety when sourcing Polygala root.

Related standards

ISO 5106:2025 references and aligns with other TCM and analytical standards such as:

• ISO 15378 (packaging/GMP), ISO 18664 (heavy metals), ISO 22283 (aflatoxins), ISO 22258 (pesticide residues), ISO 22590 (sulfur dioxide), ISO 23723 (general herbal raw material requirements) and ISO 21371 (labelling).

ISO 5106:2025 supports consistent, safer international trade of Polygala root by providing clear identification and testing requirements to protect consumers and industry stakeholders.