DEVELOPMENT OF SPECIFICATION AND CONTROL OF INPUT MATERIALS FOR THE MANUFACTURE OF AMOXICILLINE-TRIHYDRATE BASED PREPARATION

Abstract

To characterize and determine the quality of the veterinary medicinal product «Amoxidev 60» (powder for oral use) which contains amoxicillin trihydrate, in addition to physical and chemical tests, it is important to develop a specification and control of input materials intended for its production. The aim of the study was to create a drug based on amoxicillin trihydrate of appropriate quality and to substantiate the specification of control of input materials intended for its production. Veterinary drug «Amoxidev» - water-soluble white powder with a specific odor. One gram of the drug contains the active substance: amoxicillin trihydrate – 600 mg and filler: lactose – up to 1 g. The drug is prescribed to zoo animals - European deer, ornamental birds (pheasant, peacock) for the treatment and prevention of respiratory diseases (rhinotracheitis, bronchopneumonia, pneumonia), digestive (gastroenteritis, enterocolitis), genitourinary systems (metritis, nephritis, rubella) apparatus and soft tissues (injuries, myositis, dermatitis, mastitis) caused by microorganisms sensitive to the drug. Control of raw materials included the following operations: determination of the mass fraction of amoxicillin trihydrate; testing; preparation of control solution; chromatography; testing of amoxicillin trihydrate for purity; testing of amoxicillin trihydrate for the presence of accompanying impurities; determination of the pH of the test solution and the transparency of the substance solution. Based on the proposed specification and approaches to laboratory quality control of powder for oral use based on amoxicillin trihydrate developed production documentation that corresponds to the registration dossier for the veterinary drug «Amoxidev 60». The test results are properly investigated and documented in accordance with the Operating Standards Standard (SOP).