Strategies for the investigation and control of process-related impurities in drug substances

Advanced Drug Delivery Reviews

Volumn 59, Issue 1, 2007, Pages 12-28

  Argentine, Mark D ^a   Owens, Paul K ^a   Olsen, Bernard A ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

Active pharmaceutical ingredient; Chiral; Drug substance; Formaldehyde; Genotoxic impurity; Orthogonal; Process impurities; Related substances; Starting material; Sulfonate ester

Indexed keywords

ACTIVE PHARMACEUTICAL INGREDIENTS; DRUG SUBSTANCES; GENOTOXIC IMPURITY; PROCESS IMPURITIES; SULFONATE ESTERS;

DRUG PRODUCTS; FORMALDEHYDE; IDENTIFICATION (CONTROL SYSTEMS); IMPURITIES; SPECIFICATIONS; STRATEGIC PLANNING; TOXICITY;

PROCESS CONTROL;

ESTER DERIVATIVE; FORMALDEHYDE; SULFONIC ACID DERIVATIVE;

ANALYTIC METHOD; CHEMICAL ANALYSIS; CHIRALITY; DRUG IMPURITY; DRUG MANUFACTURE; ENANTIOMER; EXTRACTION; GENOTOXICITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INTERMETHOD COMPARISON; PRIORITY JOURNAL; PROCESS CONTROL; QUALITY CONTROL; REVERSED PHASE LIQUID CHROMATOGRAPHY; REVIEW; SCREENING; SEPARATION TECHNIQUE; STEREOCHEMISTRY;

CHEMISTRY, PHARMACEUTICAL; DRUG CONTAMINATION; MOLECULAR CONFORMATION; PHARMACEUTICAL PREPARATIONS;

EID: 33846833903     PISSN: 0169409X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.addr.2006.10.005     Document Type: Review

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