ISO 19609-2:2021

Overview

ISO 19609-2:2021 - Traditional Chinese medicine - Identity testing of constituents of herbal origin - defines requirements for identity testing of raw materials and finished products used in Traditional Chinese Medicine (TCM). It sits within the ISO 19609 series and focuses on practical laboratory methods and acceptance criteria to verify that herbal starting materials and herbal-origin finished products are authentic, safe and fit for use.

Keywords: ISO 19609-2:2021, Traditional Chinese Medicine, identity testing, herbal raw materials, quality control, HPLC, TLC, fingerprinting

Key topics and technical requirements

• Scope: Applies to natural products used in TCM, including starting materials and finished products of herbal origin.
• Minimum identity tests: The standard specifies core identification methods that quality systems should include:
  • Macroscopic description test
  • Microscopic description test
  • Organoleptic description test
  • High-performance liquid chromatography (HPLC) tests
  • Thin-layer chromatography (TLC) tests
• Chromatographic methods: Guidance on sample preparation (solids, semi-solids, liquids), reagents, apparatus and test solutions. It covers HPLC fingerprinting with diode-array (DAD/PDA) detection for three-dimensional ingredient profiles (time, intensity, spectrum) and group-selected identification by TLC.
• Approaches to identification: Discusses marker-based approaches (single-compound markers) versus comprehensive HPLC fingerprinting for complex multi-herbal products - emphasizing fingerprinting as a cost-effective method to detect adulteration and verify multi-constituent products.
• Additional tests: Includes chemical identification tests and references for implementation details and normative references (e.g., ISO 19609-1 for general requirements).

Practical applications

• Ensures reliable identity verification to prevent adulteration or substitution of herbal materials.
• Supports quality control during raw material receipt, manufacturing, batch release and post-market surveillance of TCM products.
• Enables laboratories to implement validated chromatographic fingerprint methods that can verify complex multi-herb formulations with a single HPLC run rather than multiple marker assays.

Who should use this standard

• Herbal product manufacturers and formulators producing TCM decoction pieces and finished products.
• Analytical and quality-control laboratories performing identity testing (HPLC/TLC).
• Regulatory agencies and conformity assessment bodies setting or verifying product quality and safety.
• Pharmacopoeial experts and R&D groups developing TCM test methods.

Related standards

• ISO 19609-1: General requirements for quality and safety of raw materials and finished products made with raw materials (TCM).
• Other pharmacopoeial references (e.g., national pharmacopoeias) are relevant for complementary assay and monograph requirements.

Use ISO 19609-2:2021 to build robust identity testing frameworks that combine traditional descriptive tests with modern chromatographic fingerprinting for transparent, reproducible verification of herbal-origin TCM materials.