Investigation into the formation of the genotoxic impurity ethyl besylate in the final step manufacturing process of UK-369,003-26, a novel PDE5 inhibitor

Organic Process Research and Development

Volumn 14, Issue 4, 2010, Pages 1027-1031

  Hajikarimian, Yousef ^a   Yeo, Steve ^b   Ryan, Robert W ^b   Levett, Philip ^a   Stoneley, Christopher ^a   Singh, Paul ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^b Global Research and Development   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACTIVE PHARMACEUTICAL INGREDIENTS; ANALYTICAL METHOD; BENZENESULFONIC ACID; BOND-FORMING STEP; COUNTERIONS; CYCLISATIONS; DEUTERATED ANALOGUE; DEUTERIUM LABELLING; DRUG DEVELOPMENT; FORMATION PROCESS; FREE BASE; GENOTOXIC IMPURITIES; GENOTOXICITIES; LOW LEVEL; MANUFACTURING PROCESS; MECHANISM OF FORMATION; MEDICINAL PRODUCTS; MUELLER; MUTUAL RECOGNITION; PDE-5 INHIBITOR; PHYSICOCHEMICAL PROPERTY; REACTION SOLVENTS; RELATED COMPOUNDS; RESIDUAL LEVELS; SIDE CHAINS; SULFONATE ESTERS; TRACE LEVEL;

DEUTERIUM; DRUG PRODUCTS; ESTERIFICATION; ESTERS; ETHANOL; IMPURITIES; MANUFACTURE; RISK ASSESSMENT; SALTS; SULFUR COMPOUNDS;

ORGANIC SOLVENTS;

EID: 77955382334     PISSN: 10836160     EISSN: 1520586X     Source Type: Journal    
DOI: 10.1021/op100141g     Document Type: Article

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