Characterization and control of impurities in the synthesis of an amino acid drug candidate

Mei Yang, Richard Thompson, Yi Hsiao, Gene Hall

Research output: Contribution to journalArticlepeer-review

Abstract

The identification of process related impurities and elucidation of the mechanism for their formation can provide invaluable input for the optimization of a pharmaceutical synthetic process. The final two steps for the synthesis of an amino acid drug candidate involve the formation of an aminonitrile followed by its hydrolysis to the amino acid. The degradation impurities were generated in both steps. The degradation products were characterized and the mechanisms for their formation were proposed. This information was then fed back to the process chemists to minimize impurity formation.

Original languageEnglish (US)
Pages (from-to)365-375
Number of pages11
JournalJournal of Liquid Chromatography and Related Technologies
Volume29
Issue number3
DOIs
StatePublished - Feb 1 2006

All Science Journal Classification (ASJC) codes

  • Analytical Chemistry
  • Biochemistry
  • Pharmaceutical Science
  • Clinical Biochemistry

Keywords

  • Degradation mechanism
  • Drug candidate
  • Identification of impurities

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