ArticleAntimicrobial agents and chemotherapy2012
Quality assessment of U.S. marketplace vancomycin for injection products using high-resolution liquid chromatography-mass spectrometry and potency assays.
Article in Antimicrobial agents and chemotherapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
16 citing papers in PubMed.
- Dual Analytical Evaluation of Generic Intravenous Vancomycin HCl in Saudi Arabia Using Microbiological and HPLC-DAD Approaches.Antibiotics (Basel, Switzerland) · 2026Article
- Do generic drugs cause hypersensitivity?European journal of dermatology : EJD · 2022Review
- A Vancomycin HPLC Assay for Use in Gut Microbiome Research.Microbiology spectrum · 2022Article
- Comparison of In Vivo Pharmacokinetics and Pharmacodynamics of Vancomycin Products Available in Korea.Yonsei medical journal · 2020Article
- In Vitro Antimicrobial Activity of Various Cefoperazone/Sulbactam Products.Antibiotics (Basel, Switzerland) · 2020Article
- Niosomes: A Strategy toward Prevention of Clinically Significant Drug Incompatibilities.Scientific reports · 2017Article
- Three structurally-related impurities in norvancomycin drug substance.The Journal of antibiotics · 2017Article
- Elution and Mechanical Strength of Vancomycin-Loaded Bone Cement: In Vitro Study of the Influence of Brand Combination.PloS one · 2016Article
- Demonstration of Therapeutic Equivalence of Fluconazole Generic Products in the Neutropenic Mouse Model of Disseminated Candidiasis.PloS one · 2015Article
- Pharmacodynamic evaluation of the activities of six parenteral vancomycin products available in the United States.Antimicrobial agents and chemotherapy · 2015Article
- Impact on resistance of the use of therapeutically equivalent generics: the case of ciprofloxacin.Antimicrobial agents and chemotherapy · 2015Article
- Precision of vancomycin and daptomycin MICs for methicillin-resistant Staphylococcus aureus and effect of subculture and storage.Journal of clinical microbiology · 2014Article
- Even apparently insignificant chemical deviations among bioequivalent generic antibiotics can lead to therapeutic nonequivalence: the case of meropenem.Antimicrobial agents and chemotherapy · 2014Article
- Comparison of six generic vancomycin products for treatment of methicillin-resistant Staphylococcus aureus experimental endocarditis in rabbits.Antimicrobial agents and chemotherapy · 2013Article
- Product quality of parenteral vancomycin products in the United States.Antimicrobial agents and chemotherapy · 2012Article
- Clinical and economic impact of generic versus brand name meropenem use in an intensive care unit in Colombia.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious DiseasesArticle
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
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).
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Registered trials
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