Overview
ISO 23964:2022 - Traditional Chinese medicine - Saposhnikovia divaricata root and rhizome specifies quality and safety requirements for dried root and rhizome of Saposhnikovia divaricata (Turcz.) Schischk. Applicable to Chinese materia medica (whole medicinal materials) and decoction pieces sold in international trade, the standard harmonizes identification, testing and acceptance criteria to support safe commerce and consistent product quality for this widely used Traditional Chinese Medicine (TCM) herb.
Key topics and technical requirements
- Scope and applicability: Covers both wild and cultivated Saposhnikovia divaricata root and rhizome used as natural medicine in international trade.
- Macroscopic identification: Visual, smell and taste characteristics for wild vs. cultivated material (appearance, crosswise/longitudinal wrinkles, cortex colour, lacunae).
- Physical and chemical limits:
- Moisture: ≤ 10.0% (mass)
- Total ash: ≤ 7.0% (mass)
- Acid‑insoluble ash: ≤ 1.5% (mass)
- Dilute ethanol‑soluble extractives: ≥ 16.0% (mass)
- Marker compound assays: Determination of characteristic constituents such as Prim‑O‑glucosylcimifugin and 5‑O‑methylvisamminoside (quantitative testing procedures referenced in annexes).
- Identity verification: Thin‑layer chromatography (TLC) identification - test and reference solutions must show corresponding spots/bands.
- Contaminant testing: Determination of heavy metals (lead, arsenic, cadmium, mercury) and pesticide residues.
- Sampling and test methods: Sampling aligned with ISO 23723; specific test methods for moisture, ash, extractives, TLC and residue determinations are referenced.
- Quality management elements: Requirements for test reports, packaging, storage and transportation, plus marking and labelling (referencing ISO 21371 and ISO 22217).
Practical applications
- Ensures consistent quality control for suppliers, manufacturers and exporters of Saposhnikovia divaricata root and rhizome.
- Supports regulatory compliance for importers, distributors and testing laboratories by providing harmonized acceptance criteria and analytical approaches.
- Guides agricultural producers and processors on acceptable physical attributes and limits for moisture, ash and extractables to meet international trade standards.
- Assists pharmacopeial and standards bodies in aligning national/regional requirements through Annex D (referenced national values) and Annex E (commercial grading examples).
Who should use ISO 23964:2022
- Herbal raw material suppliers and growers
- TCM manufacturers and formulators
- Quality control and analytical laboratories
- Importers, exporters and customs authorities
- Regulatory and standards organizations
Related standards
- ISO 23723 - General requirements for herbal raw material and materia medica (sampling)
- ISO 18664 - Determination of heavy metals in TCM herbal medicines
- ISO 22258 - Determination of pesticide residues by GC
- ISO 21371 - Labelling requirements for TCM products
- ISO 22217 - Storage requirements for raw materials and decoction pieces
Keywords: ISO 23964:2022, Saposhnikovia divaricata, Traditional Chinese Medicine, root and rhizome, Prim‑O‑glucosylcimifugin, 5‑O‑methylvisamminoside, TLC, moisture, total ash, heavy metals, pesticide residues.