Product Quality of Parenteral Vancomycin Products in the United States.
Antimicrob Agents Chemother. 2012 Feb 6;
Authors: Nambiar S, Madurawe RD, Zuk S, Khan SR, Ellison CD, Faustino PJ, Mans DJ, Trehy ML, Hadwiger ME, Boyne TM, Biswas K, Cox EM
Abstract
Introduction: In response to concerns raised about the quality of parenteral vancomycin products, the U.S. Food and Drug Administration (FDA) is investigating the product quality of all FDA-approved parenteral vancomycin products available in the U.S. Product quality was evaluated independently at two FDA Office of Testing and Research (FDA-OTR) sites. In the next phase of the investigation, being done in collaboration with the National Institute of Allergy and Infectious Diseases, the in vivo activity of these products will be evaluated in an appropriate animal model. This paper summarizes results of the FDA investigation completed thus far.Materials and Methods: One site used a validated Ultra High-Pressure Liquid Chromatography method (OTR-UPLC™) and the second site used the High Performance Liquid Chromatography (HPLC) method for related substances provided in the British Pharmacopeia (BP) monograph for Vancomycin Intravenous Infusion.Results: Similar results were obtained by the two FDA-OTR laboratories using two different analytical methods. The products tested had 90-95% vancomycin B (active component of vancomycin) by the BP-HPLC and 89-94% by OTR-UPLC™ methods respectively. Total impurities were 5-10% by BP-HPLC and 6-11% by OTR-UPLC™ methods. No single impurity was >2.0% and the CDP-1 level was ? 2.0% across all products. Some variability in impurity profiles of the various products was observed.Conclusion: No adverse product quality issues were identified with the six U.S. vancomycin parenteral products. The quality parameters of all parenteral vancomycin products tested surpassed the United States Pharmacopeia acceptance criteria. Additional testing will characterize in vivo performance characteristics of these products.
PMID: 22314525 [PubMed - as supplied by publisher]