This International Standard specifies quality, safety, identification, testing, packaging, storage, transportation, marking, and labeling requirements for Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome used as natural medicines.
ISO 25003:2026 establishes international quality and safety requirements for the dried root and rhizome of Gentiana scabra Bunge, Gentiana manshurica Kitagawa, and Gentiana triflora Palls. It covers morphological and microscopic identification, moisture, total ash, acid-insoluble ash, water-soluble extractives, thin-layer chromatographic identification, gentiopicroside determination, heavy metals, pesticide residues, sulfur dioxide, sampling, test methods, reporting, packaging, storage, transportation, marking, and labeling. The standard also provides informative methods for water-soluble extractives, thin-layer chromatography, and HPLC-UV determination of gentiopicroside, together with comparative information from national and regional requirements and botanical differentiation of the three species.
Application Scope: Applies to whole medicinal materials and decoction pieces of Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome sold or used as natural medicines in international trade, including Chinese materia medica.
