A risk-based statistical investigation of the quantification of polymorphic purity of a pharmaceutical candidate by solid-state 19F NMR

Analytica Chimica Acta

Volumn 712, Issue , 2012, Pages 30-36

  Barry, Samantha J ^a   Pham, Tran N ^a   Borman, Phil J ^a   Edwards, Andrew J ^a   Watson, Simon A ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

Author keywords

DMAIC; Fishbone; Polymorphism; Quantitative; Solid state 19F NMR; Variance

Indexed keywords

ACTIVE PHARMACEUTICAL INGREDIENTS; ANALYTICAL METHOD; CORRECTIVE ACTIONS; DESIGNED EXPERIMENTS; DMAIC; FISHBONE; METHOD VARIABILITY; POLYMORPHIC FORMS; QUANTITATIVE; REPEAT ANALYSIS; RISK-BASED; SOLID STATE NMR; STATISTICAL TOOLS; VARIANCE;

DATA HANDLING; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; POLYMORPHISM; STANDARDS; STATISTICAL MECHANICS;

RISK ASSESSMENT;

DRUG;

ARTICLE; DRUG PURITY; DRUG RESEARCH; DRUG SCREENING; DRUG STRUCTURE; FACTORIAL ANALYSIS; FLUORINE NUCLEAR MAGNETIC RESONANCE; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RISK ASSESSMENT; SAMPLING; SOLID STATE; STATISTICAL ANALYSIS; STRUCTURE ANALYSIS; VALIDATION STUDY;

CHEMISTRY, PHARMACEUTICAL; FLUORINE; MAGNETIC RESONANCE SPECTROSCOPY; PHARMACEUTICAL PREPARATIONS;

EID: 84155167220     PISSN: 00032670     EISSN: 18734324     Source Type: Journal    
DOI: 10.1016/j.aca.2011.10.064     Document Type: Article

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