Determination of the vitamin-mineral preparation ‘Energolit’ stability for the treatment of metabolic disorders in animals

Abstract

The aim of experiments was the study the shelf life of the injectable preparation ‘Energolit’ when stored in vials of light glass. Studies were carried out at a temperature within from +10 to +25 °С and relative humidity (60 ± 5%). Experiments were carried out in 3, 6, 9, 12, 18, 24 months, and one day after the expiration date after the puncture of the stopper with a sterile injection needle. The control was the newly prepared preparation. We checked organoleptic parameters, pH, microbial contamination to assess the quality of the ‘Energolit’. In addition, we determined the quantitative content of vitamins B1, B2, B3, B5, B6, and B12 by methods described in the ‘State Pharmacopoeia of Ukraine’. Three tested batches of the preparation ‘Energolit’ showed constant composition throughout all period of study during two years of storage, as well as one day after the puncture of the stopper with a sterile injection needle in the primary packaging. Experimental samples of the preparation were within possible variation during the tests on changes of pH, identity and content of the vitamins B1, B2, B3, B5, B6, and B12. Microbial contamination (Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa) was not detected. Fungi contamination were not detected during the experiment. Fungi contamination was less than 10 CFU/ml one day after the puncture. The optimal storage terms of the preparation has been determined. The findings indicated, that the shelf life of the preparation ‘Energolit’ is 2 years. The pH and mass fraction of the vitamins B group were unchanged or were within the limits of possible variation in the tested samples during the experiment. Microbial contamination was not detected.