Overview
ISO 4564:2023 specifies minimum requirements and test methods for the root of Scutellaria baicalensis (Baikal/Chinese skullcap) derived from cultivated Scutellaria baicalensis Georgi. The standard covers whole Chinese materia medica and decoction pieces sold and used as natural medicines in international trade. Its purpose is to provide systematic, reproducible criteria for quality control of Scutellaria baicalensis root used in Traditional Chinese Medicine (TCM) and related pharmaceutical applications.
Key topics and technical requirements
- Scope & applicability: Applies to cultivated Scutellaria baicalensis root for medicinal use (whole materials and decoction pieces).
- Description & morphology: Defines macroscopic features (size, colour, texture, fracture) and detailed morphological traits used for identification.
- Microscopic identification: Transverse section and powder characteristics (cork, phloem, xylem, starch granules) for laboratory confirmation.
- Chemical and physical limits:
- Moisture content: ≤ 15.0% (subject to national modification).
- Total ash: ≤ 6.0% (subject to national modification).
- Ethanol‑soluble extractives: to be determined according to methods cited.
- Marker compounds: Quantification required for baicalin, baicalein, and wogonin; Thin-layer chromatography (TLC) identification for baicalin is specified.
- Contaminant testing:
- Heavy metals (arsenic, mercury, lead, cadmium) - methods referenced.
- Pesticide residues - methods referenced.
- Sampling & test methods: Sampling procedures, minimum sample sizes, and testing protocols are specified or referenced to other ISO documents.
- Quality assurance: Test report content, packaging/storage/transportation requirements, and labelling/marking guidance are included.
- Annexes: Informative annexes provide TLC identification (Annex A), marker compound determination (Annex B), and national/regional requirement examples (Annex C).
Practical applications and users
ISO 4564:2023 is intended for:
- Quality control and analytical laboratories verifying authenticity and purity of Scutellaria baicalensis root.
- Herbal product manufacturers and pharmaceutical companies producing TCM formulations and decoction pieces.
- Importers, exporters and customs authorities involved in international trade of Chinese materia medica.
- Regulatory agencies and standards bodies integrating harmonized test methods into national pharmacopoeias.
- TCM practitioners and formulary developers who require validated quality specifications.
Related standards
Normative references in ISO 4564:2023 include:
Keywords: ISO 4564:2023, Scutellaria baicalensis root, Traditional Chinese Medicine, quality control, baicalin, baicalein, wogonin, TLC, heavy metals, pesticide residues, Chinese materia medica.