A. Pinto, V. Antonucci, C. Moeder
Nov 1, 2005
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Journal
Journal of Liquid Chromatography & Related Technologies
Abstract
Abstract Trifluorophenylacetic acid (TFPAA) was synthesized from 2,4,5‐trifluorophenyl bromide and malonic acid starting materials as part of process development for a pharmaceutical intermediate. Impurity profile methods, sensitive to positional isomers, have been developed for 2,4,5‐trifluorophenyl bromide and 2,4,5‐TFPAA. The HPLC impurity profile method for 2,4,5‐TFPAA was validated consistent with ICH guidelines. An HPLC weight percent assay method was also developed and validated for 2,4,5‐TFPAA. Residual malonic acid in 2,4,5‐TFPAA was determined with a weight percent method by GC. Non‐positional isomer impurities in 2,4,5‐TFPAA were identified by LC‐MS.