Overview
ISO 21317:2019 - Traditional Chinese medicine - Lonicera japonica flower is an international standard that specifies minimum requirements and test methods for Lonicera japonica flower (dried flower bud or flower starting to bloom of Lonicera japonica Thunb.). Designed for products sold and used as traditional Chinese medicine (TCM), the standard sets quality, safety and consistency criteria to support international trade and regulatory compliance.
Key Topics and Requirements
- Identity and description: Defines Lonicera japonica flower morphology (bud size, colour, calyx and bracts) and microscopic features (glandular and non‑glandular hairs).
- Physicochemical limits:
- Moisture: ≤ 15.0%
- Total ash: ≤ 10.0%
- Acid‑insoluble ash: ≤ 3.0%
- Dilute ethanol‑soluble extract: ≥ 16.0%
- Active marker content:
- Chlorogenic acid: ≥ 1.5%
- Luteoloside: ≥ 0.05%
- Identification of these compounds by thin layer chromatography (TLC) is required; quantitative determination procedures are provided in Annex B (chlorogenic acid) and Annex C (luteoloside).
- Contaminants and safety:
- Heavy metals (lead, arsenic, cadmium, mercury) must be determined as specified.
- Sampling and testing:
- Sampling follows WHO “Quality control methods for herbal materials” (2011).
- Test methods and reporting requirements (macroscopic/microscopic ID, moisture, ash, extractives, marker identification and content, heavy metals) are detailed in clauses and informative annexes.
- Flexibility for national adoption:
- Annex D lists national/regional reference values; member bodies may adapt some numeric limits for local standards.
Applications and Who Uses It
- TCM manufacturers and herbal processors: to control raw material acceptance, processing and batch release.
- Analytical and QC laboratories: to perform identity tests, assays for chlorogenic acid and luteoloside, moisture and ash determinations, and heavy metal analysis.
- Regulators and standards authorities: for market surveillance, import/export inspections and pharmacopoeial alignment.
- Suppliers, importers and exporters: to ensure product compliance and reduce substitution or fraud in international trade.
- Researchers and pharmacognosy specialists: as a reference for standardised characterization of Lonicera japonica flower.
Related Standards
- ISO 1575, ISO 1577 (ash methods), ISO 1666 (moisture - oven drying), ISO 18664 (heavy metals in TCM)
- WHO - Quality control methods for herbal materials (sampling)
- CODEX STAN 1:1985 (labelling guidance)
Keywords: ISO 21317:2019, Lonicera japonica flower, traditional Chinese medicine, chlorogenic acid, luteoloside, moisture, total ash, heavy metals, TLC, sampling, quality control.
