Overview - ISO 7450:2023 (Pinellia ternata tuber)
ISO 7450:2023 is the first edition international standard that defines quality and safety requirements and test methods for Pinellia ternata tuber - the dried tuber used in Traditional Chinese Medicine (TCM). The standard applies to both raw and processed Pinellia ternata tuber (including decoction pieces and materia medica) traded and used as natural medicines internationally. Note: ISO 7450:2023 does not prescribe processing methods; it standardizes identification, testing and quality control.
Key topics and technical requirements
ISO 7450:2023 covers practical laboratory and commercial controls, including:
- Description and morphological features for raw and common processed forms: liquorice‑limewater‑processed, ginger‑alum‑processed and alum‑processed Pinellia ternata tuber.
- Microscopic characteristics for botanical identification.
- Physicochemical tests such as moisture content, total ash and water‑soluble extractives.
- Analytical identification by thin‑layer chromatography (TLC).
- Contaminant testing requirements and methods for: heavy metals, pesticide residues, sulfur dioxide and microbial contamination.
- Specific tests for alum content in alum-processed forms.
- Sampling, grading, packaging, storage and labelling guidance, plus standardized test reporting.
- Informative annexes with example test methods, grading examples and referenced national values.
The standard references related ISO methods (e.g., heavy metals, pesticide residues, microorganisms, sulfur dioxide) to ensure harmonized testing practices.
Practical applications and intended users
ISO 7450:2023 is designed to support safe, traceable and quality-controlled use of Pinellia ternata tuber across the supply chain:
- Regulatory authorities and customs officials enforcing herbal medicine safety and trade compliance.
- Quality control laboratories in herbal manufacturers and contract testing labs implementing validated test methods.
- Herbal and TCM producers, suppliers and traders ensuring consistent commercial grading and labelling for international markets.
- Pharmacopeia committees and standards bodies adapting national values and integrating the standard into local regulation.
- Researchers and clinicians who require reliable identification and quality data to reduce adverse events and Pinellia poisoning.
ISO 7450:2023 helps harmonize test methods and safety criteria, improve market access for raw and processed tubers, and reduce variability in product quality.
Related standards
Relevant ISO documents cited in ISO 7450:2023 include:
For implementation details, testing labs and regulatory bodies should consult ISO 7450:2023 and the referenced ISO methods.
