title: Quality assessment of U.S. marketplace vancomycin for injection products using high-resolution liquid chromatography-mass spectrometry and potency assays.
abstract: In response to a published concern about the potency and quality of generic vancomycin products, the United States Food and Drug Administration investigated a small sampling of the vancomycin products available in North America with regard to purity, content, and potency. To facilitate identification of impurities, a new liquid chromatography method was developed using high-resolution mass spectrometry in addition to diode array detection to characterize impurities in several commercial products. Furthermore, a microbiological assay was utilized to link the analytical profiles with an in vitro potency. All products tested met the quality specifications outlined in the United States Pharmacopeia (USP) (vancomycin hydrochloride for injection monograph) for impurities and potency (USP, Vancomycin hydrochloride for injection. United States Pharmacopeia and National Formulary, vol USP 34-NF 29, 2011).
authors.affiliation: Division of Pharmaceutical Analysis, CDER, Food and Drug Administration, St Louis, Missouri, USA.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Hadwiger
authors.forename: Cynthia D
authors.initials: CD
authors.lastname: Sommers
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Mans
authors.forename: Vikram
authors.initials: V
authors.lastname: Patel
authors.forename: Michael T
authors.initials: MT
authors.lastname: Boyne
mesh_terms: D002853:Chromatography, Liquid / Q000379:methods*; D003257:Consumer Product Safety; D013058:Mass Spectrometry / Q000379:methods*; D011786:Quality Control; D014481:United States; D014640:Vancomycin
chemical_list: D014640:Vancomycin