ISO 9109:2024

Overview

ISO 9109:2024 - Traditional Chinese medicine - Rehmannia glutinosa root is the first edition International Standard that defines quality requirements and test methods for dried Rehmannia glutinosa root (derived from Rehmannia glutinosa Libosch.). The standard applies to whole medicinal material and decoction pieces traded and used as natural medicine internationally. Fresh and processed Rehmannia root are explicitly excluded.

Keywords: ISO 9109:2024, Rehmannia glutinosa root, traditional Chinese medicine, dried root, Chinese materia medica

Key topics and technical requirements

• Scope and exclusions: Applies only to dried root for medicinal use; excludes fresh and processed products.
• Description & morphology: Typical root morphology, colour, texture and size (root length ~6–12 cm; diameter ~2–6 cm).
• Physical and microscopic characteristics: Macroscopic and powder microscopy features (cork cells, parenchyma, secretory cells, vessels).
• Quality limits and tests:
  • Moisture - mass fraction determined (method referenced).
  • Total ash - mass fraction not more than 8.0%.
  • Acid‑insoluble ash - mass fraction not more than 3.0%.
  • Water‑soluble extractives - mass fraction determined.
  • TLC identification - marker compounds (e.g., catalpol, verbascoside) must present matching spots/bands (same position and colour) in test and reference solutions.
  • Marker compound assays - determination of catalpol and rehmannioside D content (informative annexes give identification and assay procedures).
  • Contaminants - heavy metals (As, Hg, Pb, Cd), pesticide residues (e.g., HCH, DDT, PCNB) and sulfur dioxide residues to be determined.
• Sampling & test methods: Sampling according to ISO 23723; test method clauses cover macroscopic ID, moisture, ash, TLC, marker assays, heavy metals, pesticides and sulfur dioxide.
• Additional provisions: Grading guidance (Annex E), national/regional value recommendations (Annex F), packaging/storage/transportation and labelling requirements.

Applications and who uses this standard

• Manufacturers and processors - ensure raw-material quality specifications for dried Rehmannia root.
• Exporters / importers & distributors - compliance for international trade, product acceptance and grading.
• Quality control and analytical laboratories - implement validated test methods for catalpol, rehmannioside D, ash, moisture, heavy metals and pesticide residues.
• Regulators and standards bodies - reference for establishing national limits or inspection criteria.
• Practitioners and supply-chain managers - assurance of authenticity, safety and consistency in Chinese materia medica.

Related standards

• ISO 23723 - General requirements for herbal raw material and sampling
• ISO 18664 - Determination of heavy metals in TCM herbal medicines
• ISO 22258, ISO 22590, ISO 22217, ISO 21371, ISO 23193 - related methods for pesticide, sulfur dioxide, storage and labelling

ISO 9109:2024 provides a harmonized framework to support safety, authenticity and trade of Rehmannia glutinosa root in the global TCM market.