Chemical Analysis and the Study of Quality Indicators of the Immunobiological Drug for Preventing and Treating Candidal Infections

Abstract

Quality indicators such as protein content, polysaccharide content, phenol content, and pH of the developed vaccine solution for injection (VSI) “Candidocyde” based on cells of C. albicans and C. tropicalis fungi have been found to meet the standard requirements. It was determined that by the indicator of transparency and degree of turbidity the test solution is transparent, by the coloration degree it is colorless, by the sterility indicator it is sterile. The sterility period, determined after the first opening, is 8 hours. It was found that no solid particles were present in the solution; the container with the solution is hermetic; the volume of the container with a solution is not less than 5.0 ml. The test solution is stable for 2 years of storage at 275-265 K.