Is HPLC assay for drug substance a useful quality control attribute?

Journal of Pharmaceutical and Biomedical Analysis

Volumn 44, Issue 4, 2007, Pages 906-913

  Hofer, Jeffrey D ^a   Olsen, Bernard A ^a   Rickard, Eugene C ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

Assay variability; Drug substance; HPLC assay; Out of specification; Precision

Indexed keywords

DORZOLAMIDE; INDINAVIR; LANSOPRAZOLE; MEVINOLIN; TACRINE;

ACCURACY; ARTICLE; COMPARATIVE STUDY; DATA ANALYSIS; DRUG MANUFACTURE; DRUG PURITY; DRUG QUALITY; DRUG STABILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PRIORITY JOURNAL; QUALITY CONTROL;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG COMPOUNDING; DRUG INDUSTRY; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS;

EID: 34447640143     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2007.04.023     Document Type: Article

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