Applying QbD principles to develop a generic UHPLC method which facilitates continual improvement and innovation throughout the product lifecycle for a commercial API

Organic Process Research and Development

Volumn 17, Issue 1, 2013, Pages 87-96

  Musters, Jacky ^a   Van Den Bos, Leendert ^a   Kellenbach, Edwin ^a  

^a MSD Oss BV   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ACCEPTANCE CRITERIA; CHEMICAL ENTITY; CONTROL STRATEGIES; DESIGN SPACES; DRUG SAFETY; DRUG SUBSTANCES; FLOW SCHEMES; MANUFACTURING PROCESS; NEW CHEMICAL ENTITIES; PROCESS CAPABILITIES; PROCESS UNDERSTANDING; PRODUCT-LIFE-CYCLE; PRODUCTION PROCESS; PRODUCTION ROUTE; QUALITY BY DESIGNS; RETENTION TIME;

DRUG PRODUCTS; PRODUCTION ENGINEERING; SPECIFICATIONS;

PRODUCT DESIGN;

EID: 84872744434     PISSN: 10836160     EISSN: 1520586X     Source Type: Journal    
DOI: 10.1021/op300292a     Document Type: Article

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