ISO 21370:2019

Overview

ISO 21370:2019 - Traditional Chinese medicine - Dendrobium officinale stem defines minimum requirements and test methods for the dried and processed stems of cultivated Dendrobium officinale Kimura et Migo. It applies to whole Chinese materia medica and decoction pieces derived from this plant and is intended to harmonize quality assessment, reduce adulteration, and support safe international trade of this widely used herbal material.

Key topics and requirements

• Scope and trade forms: Covers fresh stem, dried stem and processed stem (Tie Pi Feng Dou), with macroscopic descriptions for each form (shape, colour, texture, odour, taste).
• Identity testing: Thin-layer chromatography (TLC) identification to match spots/bands with a reference standard (Annex A).
• Chemical and physical limits:
  • Moisture: mass fraction ≤ 14.0% (fresh stem exempt).
  • Total ash: mass fraction ≤ 7.0% (fresh stem exempt).
  • Ethanol‑soluble extractives: mass fraction ≥ 5.0% (fresh stem exempt).
• Marker compounds: Determination of polysaccharides, mannose and the peak area ratio of mannose to glucose (dried material tested; methods in Annexes C and D).
• Contaminants:
  • Heavy metals (arsenic, mercury, lead, cadmium) - testing per ISO 18664.
  • Pesticide residues (e.g., Benzex, DDT, quintozene) - testing per CODEX STAN 229 and CAC/MRL01.
• Sampling and test methods: Sampling follows WHO guidance for herbal materials; specific test procedures reference ISO 1575 (total ash), ISO 20409 (moisture), and other annex procedures for extractives and marker assays.
• Reporting and handling: Detailed test report requirements, plus requirements for packaging, storage, transportation and labelling (see ISO 21371 for labelling).

Applications and users

ISO 21370:2019 is practical for:

• Quality control laboratories performing identity, purity and contaminant testing for Dendrobium officinale.
• Herbal manufacturers and processors implementing standardized acceptance criteria for raw material and decoction pieces.
• Regulators and standards bodies harmonizing national limits and conformity assessment for Traditional Chinese Medicine (TCM) products.
• Importers, distributors and traders ensuring compliance with international quality and labelling requirements.
• Research institutions studying marker compounds (polysaccharides, mannose) and quality markers for Dendrobium officinale.

Using ISO 21370:2019 helps prevent adulteration, supports consistent quality, and facilitates safer international trade of Dendrobium officinale stem.

Related standards

• ISO 1575 (total ash)
• ISO 18664 (heavy metals in TCM)
• ISO 20409 (moisture for Panax notoginseng reference; applied here)
• ISO 21371 (labelling requirements for TCM products)
• CODEX STAN 229 and CAC/MRL01 (pesticide residue analysis and limits)
• WHO Quality Control Methods for Herbal Materials (sampling guidance)