Overview
ISO 23723:2021 - Traditional Chinese medicine - General requirements for herbal raw material and materia medica - provides an international, baseline framework of quality, safety and test methods for herbal raw materials and Chinese materia medica. It specifies minimum requirements for species not covered by existing single‑species standards and distills common requirements found in national and regional pharmacopoeias. The standard is intended to support consistent identification, testing, sampling, packaging, labelling, storage and transportation of herbal materials used in Traditional Chinese Medicine (TCM).
Key topics and technical requirements
ISO 23723:2021 focuses on general, practical controls and laboratory methods rather than species‑specific limits. Major technical topics include:
- Identification: macroscopic and microscopic examination, thin‑layer chromatography (TLC) and HPLC identification for constituent verification.
- Quality requirements: tests for moisture/loss on drying, foreign matter, total ash and acid‑insoluble ash, assay, extractives, essential oil content, rancidity and degree of colouration.
- Safety requirements: screening and test methods for heavy metals (including arsenic), pesticide residues, sulfur dioxide residues, aflatoxins, aristolochic acids, selected Aconitum alkaloids and microbial contamination.
- Methods and reporting: standardized test methods and guidance for test reports, sampling procedures and minimum documentation.
- Logistics and labeling: requirements for packaging, labelling and storage/transportation to maintain quality and traceability.
- Scope supplement: Annex A provides cross‑references to monographs in national and regional pharmacopoeias to locate specific limit values.
The standard references established ISO methods (e.g., ISO 18664 for heavy metals, ISO 22258 for pesticide residues, ISO 22283 for aflatoxins, ISO 23190 for aristolochic acids and ISO 23191 for Aconitum alkaloids) and WHO quality guidance.
Practical applications - who uses ISO 23723
ISO 23723 is practical for organizations involved in the TCM herbal supply chain that need a harmonized, internationally‑recognized baseline:
- Herbal raw material suppliers and collectors seeking clear acceptance criteria and testing guidance.
- Manufacturers of TCM products and nutraceuticals applying raw material quality control.
- Analytical laboratories implementing standardized test methods for herbal materials.
- Regulatory authorities and quality assurance teams using the standard for compliance, import/export checks and pharmacovigilance.
- Standards bodies and pharmacopoeia authors referencing general requirements when drafting species‑specific monographs.
Related standards
Relevant ISO documents cited in ISO 23723 include (selection):
- ISO 18664 - Determination of heavy metals in herbal medicines
- ISO 22258 - Determination of pesticide residues by GC
- ISO 22283 - Determination of aflatoxins by LC‑FLD
- ISO 23190 / ISO 23191 - Determination of aristolochic acids and Aconitum alkaloids
- ISO 22467 (microorganisms), ISO 1573/1575/1577 (ash and loss in mass)
ISO 23723:2021 is a practical, SEO‑relevant reference for anyone working with Traditional Chinese medicine, herbal raw material quality, and materia medica safety.
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