Overview
ISO 25115:2026, Traditional Chinese medicine - Cultivated Cistanche deserticola stem, sets internationally recognized quality and safety requirements for cultivated Cistanche deserticola stem (Rou Cong Rong), derived from the plant Cistanche deserticola Y.C. Ma. This standard applies to both whole medicinal materials (Chinese materia medica) and decoction pieces intended for natural medicine products involved in international trade. The document provides guidelines to ensure product integrity, quality consistency, and consumer safety, making it essential for stakeholders engaged in the cultivation, processing, and distribution of Cistanche deserticola stem.
Key Topics
- Product Identity & Description: Defines cultivated Cistanche deserticola stem, describing its flat-cylindrical shape, characteristic appearance, odor, and taste.
- Quality Requirements:
- Moisture content (max 20.0%)
- Total ash content (max 11.0%)
- Dilute ethanol-soluble extractives (min 35.0%)
- Safety Criteria:
- Heavy metals and pesticide residue levels must be determined using standardized ISO methods.
- Identification Methods: Includes macroscopic examination and thin-layer chromatography (TLC) for effective product verification.
- Marker Compounds: Specifies content determination of medicinal marker compounds such as echinacoside and verbascoside to authenticate quality.
Applications
ISO 25115:2026 is particularly relevant for:
- Growers and Producers: Enables consistent production quality across cultivated Cistanche deserticola supply chains, supporting environmental conservation by promoting cultivated sources over wild harvesting.
- Exporters and Traders: Facilitates compliance in international commerce by providing harmonized requirements for quality, labeling, and safety assessment - reducing trade barriers linked to varying national standards.
- Pharmaceutical and Herbal Product Manufacturers: Ensures the integrity of raw materials used in the preparation of traditional Chinese medicines, dietary supplements, and related health products.
- Quality Control Laboratories: Guides standard test methods for verifying cultivated Cistanche deserticola stem’s identity, purity, and composition, helping laboratories meet regulatory and commercial requirements.
- Regulatory Authorities: Assists government bodies in evaluating product compliance for import and market approval, protecting consumer health and supporting fair trade.
Related Standards
For comprehensive compliance and quality assurance in traditional Chinese medicine and herbal raw material trade, consider the following related ISO standards:
- ISO 18664: Determination of heavy metals in herbal medicines.
- ISO 21371: Labelling requirements of products intended for oral or topical use.
- ISO 22217: Storage requirements for raw materials and decoction pieces.
- ISO 22258: Determination of pesticide residues in natural products by gas chromatography.
- ISO 23723: General requirements for herbal raw material and materia medica.
These related standards, when used in conjunction with ISO 25115:2026, form a robust framework for the secure, ethical, and effective international trade and use of cultivated Cistanche deserticola stem in traditional medicine.
Keywords: ISO 25115:2026, Cistanche deserticola stem standard, traditional Chinese medicine, cultivated Cistanche quality, herbal medicine safety, materia medica trade compliance, Cistanche export regulations, TLC identification, herbal pharmacopoeia standards.