A generic approach for the determination of trace hydrazine in drug substances using in situ derivatization-headspace GC-MS

Journal of Pharmaceutical and Biomedical Analysis

Volumn 49, Issue 2, 2009, Pages 529-533

  Sun, Mingjiang ^a   Bai, Lin ^a   Liu, David Q ^a  

^a GLAXOSMITHKLINE   (United States)

Author keywords

Drug substance; GC MS; Genotoxic impurity; Headspace; Hydrazine

Indexed keywords

ACETONE; HYDRAZINE;

ANALYTIC METHOD; ARTICLE; BATCH PROCESS; DERIVATIZATION; DRUG DETERMINATION; DRUG MANUFACTURE; MASS FRAGMENTOGRAPHY; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS;

ACETONE; CHEMISTRY, PHARMACEUTICAL; DRUGS, GENERIC; GAS CHROMATOGRAPHY-MASS SPECTROMETRY; HYDRAZINES; MOLECULAR STRUCTURE; PHARMACEUTICAL PREPARATIONS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 59049102650     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2008.11.009     Document Type: Article

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