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

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