436254 Development of a Challenging Salt Formation Step for a Phosphate API

Wednesday, November 11, 2015
Exhibit Hall 1 (Salt Palace Convention Center)
Antonio C. Ferretti and John F. Traverse, Drug Substance Development, Celgene, Summit, NJ

The development of a final API step involving salt formation is described. Challenging properties of this system include: (1) the free base API has low solubility in most organic solvents; (2) residual solvent is difficult to reduce below desired limits; (3) salt disproportionaton occurs at mild temperatures. A process that addresses these challenges was developed, generating API with desired physical properties.

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See more of this Session: Poster Session: Pharmaceutical
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum