Overview
ISO 21314:2019 - Traditional Chinese medicine - Salvia miltiorrhiza root and rhizome defines minimum quality requirements and test methods for the dried root and rhizome of Salvia miltiorrhiza Bge. Intended for materials sold and used as natural medicine in international trade, the standard covers unprocessed and traditionally processed material and supports consistent safety, identity and chemical quality for clinical use and commerce.
Key topics and technical requirements
The standard sets both descriptive and analytical controls, with clear pass/fail limits and referenced test methods:
Note: national bodies may adapt some numeric limits (clauses 5.2.3–5.2.8) for national standards.
Applications and users
ISO 21314 is practical for:
- Quality control laboratories and analytical chemists validating identity and potency.
- Herbal product manufacturers, formulators and extract producers ensuring raw-material acceptance.
- Importers/exporters and traders needing harmonized specifications for international trade.
- Regulatory agencies and pharmacopoeial bodies seeking a reference for monograph development.
- Clinical researchers sourcing standardized botanical material for studies.
Adopting ISO 21314 helps reduce trade barriers, harmonize chemical marker criteria (tanshinones, salvianolic acid B), and improve consumer safety for Salvia miltiorrhiza products.
Related standards
- ISO 20409 (moisture determination)
- ISO 928 / ISO 930 (ash determinations)
- ISO 18664 (heavy metals in TCM herbs)
- ISO 21371 (labelling requirements)
- Codex STAN 229 / CAC MRL01 (pesticide analysis & MRLs)
- WHO Quality Control Methods for Herbal Materials
Keywords: ISO 21314, Salvia miltiorrhiza, traditional Chinese medicine, quality control, tanshinones, salvianolic acid B, TLC identification, herbal standards, international trade.