Analytical Development

  • An experienced organization with a balance of Ph.D., MSc and BSc analytical chemists

  • Range of experience from 5 to 30 years in analytical services

  • Common analytical platforms across all sites, to facilitate technology transfer between internal and external customers

  • Extensive analytical method development, qualification and validation capabilities

  • Structural elucidation competencies using a range of advanced techniques including absolute configuration, polymorphism, particle size analysis, and solubility determination

Analytical Development

  • Extensive salt screening capabilities and rigorous protocols
  • Specification development and justification
  • Impurity marker and reference standard preparation, qualification, management and distribution
  • Stability and forced degradation studies
  • Routine support for development and manufacturing activities
  • cGMP analysis of raw materials, in-process samples, intermediates, and finished products
  • Analytical support for investigations
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