Quality of Vancomycin for Injection Formulations in Brazil

Abstract

Background: The presence of impurities in vancomycin compromised the safety and contributed to decrease of its use for years. In Brazil, vancomycin generic drug represents an option to reduce hospital costs. However, the controversy over the quality of these formulations and their relationship to effectiveness and safety raised concerns. Objective and Methods: To assess in vitro quality of vancomycin injections through uniformity of weight, pH, clarity of solution, microbiological assay and impurities determination by High Performance Liquid Chromatography (HPLC). Results: The samples were approved in the tests. Conclusion: The injectable formulations of vancomycin proved to be safe for use in hospital environment. This work contributes to increase health professionals’ confidence on generic vancomycin.