Use of a Quality-by-Design approach to justify removal of the HPLC weight % assay from routine API stability testing protocols

Journal of Pharmaceutical and Biomedical Analysis

Volumn 50, Issue 5, 2009, Pages 794-796

  Skrdla, Peter J ^a   Wang, Tao ^a   Antonucci, Vincent ^a   Dowling, Thomas ^a   Ge, Zhihong ^a   Ellison, Dean ^a   Curran, John ^a   Mohan, Ganapathy ^a   Wyvratt, Jean ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Analytical methods; Quality by Design (QbD); Regulatory; Stability; Testing protocol

Indexed keywords

ACCURACY; ANALYTICAL ERROR; ARTICLE; DRUG RESEARCH; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY;

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

EID: 70349166746     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2009.06.027     Document Type: Article

References (8)

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