Chemistry and quality control of raw materials in the production of the veterinary drug “Devivit Selen”: an example of vitamin E and selenium, benzyl alcohol and water for injection

The paper presents the results of a comprehensive quality control of the input substances used in the production of the veterinary drug “Devivit Selen”. Four key components were involved in the study: vitamin E (tocopherol acetate) and selenium (in the form of sodium selenite), benzyl alcohol and water for injection. The aim of the work was to experimentally substantiate the physicochemical quality indicators of these substances in accordance with the requirements of the State Pharmacopoeia of Ukraine. The control was carried out in the laboratory for quality control, safety and registration of veterinary medicines and feed additives of LLC “DEVIE”. The results obtained confirmed the compliance of all the studied substances with the established pharmacopoeial standards. It was determined that the quality of each component significantly affects the stability, effectiveness and safety of the drug. In particular, the purity of water for injection and benzyl alcohol ensures the sterility of the dosage form, while the concentration of vitamin E and selenium determines the antioxidant activity and therapeutic effect of the drug. The control methods used were based on the principles of validation, metrological traceability and compliance with GMP requirements. The analysis confirmed the high quality of each substance, which allows to guarantee the stability of the drug throughout the entire shelf life. The results of the study are of practical importance for increasing the efficiency of internal quality control at pharmaceutical enterprises. They can be used in the educational process for training veterinary and pharmaceutical specialists. The work demonstrates the importance of integrating modern analytical methods into the GMP system for improving the production of veterinary drugs. A comprehensive approach to the control of input materials is the key to high quality and safety of finished dosage forms.