T/SDVDA 001-2022: Extract of Radix Isatidis and Ephedra Herb for Veterinary Drugs
T/SDVDA 001-2022
Basic Information
Scope
Main Technical Content: The drafting process of this standard primarily references the Second Part of the Pharmacopoeia of the People's Republic of China (2020 Edition) and the Chinese Volume of the Veterinary Drug Quality Standards (2017 Edition). This standard specifies the terms and definitions, technical indicators, sampling, testing methods, inspection rules, packaging, transportation, storage, and shelf life of Radix Isatidis and Herba Coptidis extracts used in veterinary preparations. 1. Standard Name: "Radix Isatidis and Herba Coptidis Extracts for Veterinary Preparations". 2. Scope: This standard specifies the terms and definitions, technical indicators, sampling, testing methods, inspection rules, packaging, transportation, storage, and shelf life of Radix Isatidis and Herba Coptidis extracts used in veterinary preparations. It applies to intermediates of liver and gallbladder granules, as well as other extracts with the same extraction process. 3. Normative Reference Documents: This standard references and cites the latest domestic advanced standards to ensure the enforceability and feasibility of its provisions. 4. Technical Indicators: This standard establishes the technical indicators for Radix Isatidis and Herba Coptidis extracts used in veterinary preparations, which shall comply with Table 1. - Table 1: Technical Indicators - Arginine Identification: In the thin-layer chromatogram, a spot of the same color as the control sample should appear at the corresponding position. - Herba Coptidis Identification: In the fluorescence chromatogram, a fluorescent spot of the same color as the control herbal medicine should appear at the corresponding position. - Relative Density: 1.25–1.35 (60°C). All components should dissolve completely without insoluble matter. 5. Test Methods: The test methods in this standard refer to and cite the Pharmacopoeia of the People's Republic of China, Second Part, and the Veterinary Drug National