Quality of Vancomycin for Injection Formulations in Brazil

Author(s): Gabriela Secco, Cristiane Sachetti, Luciana Grazziotin Rossato-Grando, Siomara Regina Hahn, Lidiane Riva Pagnussat, Paula Maria Façanha da Cruz Fresco, Charise Dallazem Bertol*.

Journal Name: Current Pharmaceutical Analysis

Volume 15 , Issue 3 , 2019

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Graphical Abstract:


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.

Keywords: Generic, impurities, HPLC, injections, quality control, vancomycin.

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Article Details

VOLUME: 15
ISSUE: 3
Year: 2019
Page: [280 - 285]
Pages: 6
DOI: 10.2174/1573412914666180116143232
Price: $58

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