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The aim of the study is to create a preparation based on colistin sulfate of appropriate quality and justify the process of its production in order to constantly produce products with specified functional characteristics. The objects of the study were experimental samples of the veterinary medicinal product «Kolidev 8M» (powder for oral use) (TU 21.2-40781800-034: 2022) which includes colistin sulfate, as well as excipients: glucose and citric acid. Taking into account modern pharmacopoeial requirements, obtained pharmaco-technological and physico-chemical characteristics, a specification for a veterinary medicinal product has been developed and substantiated, which includes the following quality indicators: composition, identification, packaging, stor-age, shelf life. Developed technological instructions for the production of «Kolidev 8M», which is responsible for the technological process and provides for the following operations: preparation for production, prepara-tion of the drug, packaging, sterilization, labeling and packaging of antibacterial drugs, labor protection re-quirements, industrial sanitation and fire safety. |
