Overview
ISO 5471:2024 - Traditional Chinese medicine - Carthamus tinctorius flower is the first edition (2024) international standard that defines minimum quality, safety and test-method requirements for dried Carthamus tinctorius Linné flowers (safflower) when sold and used as Chinese materia medica. The standard addresses identification, contamination risks and analytical tests to support consistent quality, clinical effectiveness and safe international trade of Carthamus tinctorius flower.
Key technical topics and requirements
- Scope and applicability
- Applies to the dried tubulous flower of Carthamus tinctorius Linné used in Traditional Chinese Medicine (TCM) and global trade.
- Identity and macroscopic description
- Morphology: tubulous flower length, tubular corolla colour (orange‑red to red), 5‑lobed apex, stamens and stigma features; odour slightly fragrant, taste slightly bitter.
- Analytical limits and quality criteria
- Moisture: mass fraction ≤ 13.0%
- Total ash: mass fraction ≤ 18.0%
- Acid‑insoluble ash: mass fraction ≤ 5.0%
- Absorbance (red pigment at 518 nm): ≥ 0.20
- Water‑soluble extract: mass fraction ≥ 30.0%
- Marker compounds: determination of flavonoids, e.g. hydroxysafflor yellow A and kaempferol
- Contaminants: determination of heavy metals (As, Hg, Pb, Cd), pesticide residues, sulfur dioxide and aflatoxins
- Identification and test methods
- Macroscopic inspection and thin‑layer chromatography (TLC) for identity (Annex A)
- Specific test methods and procedures for moisture, ash, pigment absorbance (Annex B), marker quantification (Annex C/D), and contamination testing
- Sampling, reporting and handling
- Sampling per ISO 23723; requirements for test reporting, packaging, storage, transportation, marking and labelling are specified.
Practical applications - who uses ISO 5471:2024
- Quality control laboratories testing herbal raw materials for compliance with TCM standards
- Manufacturers and suppliers of TCM herbs and botanical ingredients to ensure product consistency
- Regulators and customs authorities assessing imported/exported Carthamus tinctorius flower for safety and labelling compliance
- Herbal product formulators and distributors seeking verified raw‑material specifications
- Research institutions conducting pharmacognosy or phytochemical studies on safflower constituents (hydroxysafflor yellow A, kaempferol)
- Buyers and traders who need to mitigate adulteration risks (added pigments, fillers, contaminants)
Related standards and supporting documents
Normative references cited in ISO 5471:2024 include:
ISO 5471:2024 helps harmonize herbal medicine testing, safflower quality control, and international trade practices for Carthamus tinctorius flower.
