Development and validation of a sensitive and robust wipe-test method for the detection and quantification of the antibiotic ertapenem and its primary degradates in a pharmaceutical manufacturing environment

Journal of Liquid Chromatography and Related Technologies

Volumn 28, Issue 5, 2005, Pages 713-725

  Sajonz, Peter ^a   Natishan, Theresa K ^a   Wu, Yan ^a   McGachy, Neil T ^a   De Tora, David ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Antibiotics; Cleaning validation; Ertapenem; HPLC; Manufacturing; Pharmaceuticals; Swab analysis

Indexed keywords

ACETONITRILE; ANTIBIOTICS; PH EFFECTS; SOLUTIONS; ULTRAVIOLET DETECTORS;

ACID BUFFERS; LIMIT OF DETECTION (LOD); LIMIT OF QUANTITATION (LOQ); SOLUTION STABILITY;

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY;

ACETONITRILE; ERTAPENEM; PHOSPHORIC ACID;

AQUEOUS SOLUTION; ARTICLE; DRUG DEGRADATION; DRUG DETERMINATION; DRUG MANUFACTURE; ELUTION; ENVIRONMENTAL TEMPERATURE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HYDROLYSIS; METHODOLOGY; QUANTITATIVE ANALYSIS; RESIDUE ANALYSIS; ULTRAVIOLET RADIATION; VALIDATION PROCESS; WIPE TEST;

EID: 14644408710     PISSN: 10826076     EISSN: None     Source Type: Journal    
DOI: 10.1081/JLC-200048892     Document Type: Article

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