Development of a safe and scalable oxidation process for the preparation of 6-hydroxybuspirone: Application of in-line monitoring for process ruggedness and product quality

Organic Process Research and Development

Volumn 8, Issue 4, 2004, Pages 616-623

  Watson, Daniel J ^a   Dowdy, Eric D ^a   DePue, Jeffrey S ^a   Kotnis, Atul S ^a   Leung, Simon ^a   O'Reilly, Brian C ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

6 HYDROXYBUSPIRONE; BUSPIRONE; UNCLASSIFIED DRUG;

ARTICLE; CRYSTALLIZATION; DRUG PURIFICATION; HYDROXYLATION; INFRARED SPECTROSCOPY; MONITORING; OXIDATION; PROCESS DEVELOPMENT;

EID: 4243195879     PISSN: 10836160     EISSN: None     Source Type: Journal    
DOI: 10.1021/op049918r     Document Type: Article

References (10)

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8. (c) Yevich, J. P.; Mayol, R. F.; Li, J.; Yocca, F. U.S. Patent 2003/0022899 A1.
9. If the oxygen off-gas concentration had crept near 6%, the oxygen sparge would have been replaced with a nitrogen sparge and the combination of the two nitrogen streams would have quickly reduced the oxygen concentrations. It should also be noted that one can purchase custom filled cylinders containing 5% oxygen in nitrogen.
10. FDA Draft Guidance for Industry; PAT-A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, August 2003.