PHARMACOTECHNOLOGICAL QUALITY INDICATORS OF THE VETERINARY DRUG BASED ON CALCIUM GLUCONATE

Abstract

In order to characterize and determine the quality of the veterinary medicinal product «Solution of calcium borgluconate 20%» (solution for injections), which contains calcium gluconate, its proper production, quality control and appropriate storage remain important. The purpose of the research is to develop the characteristics of the finished medicinal product, manufacturing technology and methods of quality control of the active substance and auxiliary substances of the injectable medicinal product based on calcium gluconate. The veterinary drug «Solution of calcium borogluconate 20%» is a transparent, colorless, non-viscous liquid with a specific smell. 100 ml of the drug contain the active substance – calcium gluconate – 20,0 g. Excipients: boric acid, butyl alcohol, water for injections. The drug is prescribed for the prevention and treatment of animals, for diseases caused by insufficient or reduced calcium metabolism in the body: rickets, hemorrhagic diathesis, urticaria, prenatal and postpartum addictions, postpartum paresis, tetany during pregnancy, as well as allergies and toxicosis. The work presents the characteristics of the finished veterinary medicinal product «Solution of calcium borogluconate 20%» (solution for injections), describes the technological features of manufacturing and standardization of the calcium-containing preparation, and offers a specification for the active substance and auxiliary substances. Standardization of the injection drug includes: checking the appearance of the incoming raw materials, identification of active substances, quantitative determination of the active substance and excipients. On the basis of the proposed specification and approaches to laboratory quality control of the solution for injections based on calcium gluconate, production documentation was developed that corresponds to the materials of the registration dossier for the veterinary drug «Solution of calcium borogluconate 20%». Test results are properly investigated and documented in accordance with the standard operating procedure (SOP).