ISO 20409:2017

Overview

ISO 20409:2017 - Traditional Chinese medicine - Panax notoginseng root and rhizome provides internationally harmonized quality, safety and test method requirements for dried Panax notoginseng (Sanqi) root and rhizome used as food supplements, functional food or natural medicines. The standard supports consistent identification and quality control of Chinese materia medica and decoction pieces in international trade, helping to reduce substitution, adulteration and safety risks.

Key topics and technical requirements

The standard defines descriptive features, minimum quality limits and analytical tests for notoginseng root and rhizome. Major technical points include:

• Identity and description

  • Botanical source: Panax notoginseng (Burk.) F.H. Chen.
  • Morphology: tap root shape (subconical/cylindrical), root length 1–6 cm, diameter 1–4 cm, surface and fracture characteristics.

• General quality requirements

  • Clean, free from rootlets and foreign matter; no living insects, mould or visible contaminants.

• Physicochemical limits

  • Moisture ≤ 12.0% (w/w)
  • Total ash ≤ 6.0% (w/w)
  • Acid‑insoluble ash ≤ 1.0% (w/w)
  • Ethanol‑soluble extractives > 16.0% (w/w)

• Chemical markers and identification

  • Identification of notoginsenoside R and ginsenosides Rg, Re, Rb by TLC or HPLC (matching spots/peaks).
  • Content requirement: sum of notoginsenoside R + ginsenosides Rg + Rb ≥ 5.0% (mass fraction).

• Contaminant testing

  • Determination of heavy metals (As, Hg, Pb, Cd) and pesticide residues.
  • Requirements for sampling, test reporting, packaging, storage and labelling.

• Test methods

  • Macroscopic identification, moisture, total ash, acid‑insoluble ash, ethanol‑soluble extractives, TLC/HPLC for ginsenosides; root weight/length/number measurements are specified.

Practical applications - who uses this standard

ISO 20409:2017 is essential for:

• Manufacturers and processors of Panax notoginseng products (herbal suppliers, decoction-piece producers).
• Quality control and analytical laboratories performing TLC/HPLC, moisture and heavy metal testing.
• Importers/exporters and regulatory authorities assuring safety and authenticity in international trade.
• Traders, contract manufacturers and product developers of food supplements, functional foods and natural medicines seeking compliance with international quality benchmarks.
• Practitioners and buyers concerned with provenance and consistency of Chinese materia medica.

Related standards

• ISO 1575, ISO 1577 - ash determinations (tea methods referenced)
• ISO 18664 - Determination of heavy metals in TCM herbal medicines
• Codex standards and CAC/MRL01 - pesticide residue guidance
• WHO Quality Control Methods for Herbal Materials (sampling guidance)

ISO 20409:2017 is a practical tool for improving quality control, safety and traceability of Panax notoginseng in global markets. Keywords: ISO 20409:2017, Panax notoginseng, notoginseng root and rhizome, traditional Chinese medicine, ginsenosides, TLC, HPLC, quality control, heavy metals, pesticide residues.