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Abstract
CP-93,393-1 is a new chemical entity under development for the treatment of anxiety and depression. This paper describes the selection and validation of a chromatographic system which was engineered to: (1) ensure acceptability by world-wide regulatory agencies, (2) maximize sample throughput, (3) simplify the analysis, (4) minimize ambiguity in peak assignments, and (5) facilitate the technology-transfer process. These objectives were achieved using a single, compound-specific and purity-indicating, isocratic, reversed-phase chromatographic system that allows quantitation of CP-93,393 concomitantly with all potential impurities from the same injection. A novel experimental matrix was employed to validate the chromatographic system.
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