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

Activities

  • Analytical method development
  • Analytical method qualification & validation
  • Forced degradation studies
  • Impurity isolation and characterization
  • Reference standard qualification
  • Nitrosamines content estimations by HR-MS, LC-MS and GC-MS
  • Genotoxic content estimations by GC, HPLC, GC-MS and LC-MS
  • Stability studies as per ICH guidelines

Infrastructure

  • NMR (Solid state 400 MHz)
  • NMR (Liquid state 300 MHz)
  • XRD
  • ICP-MS
  • LC-MS-MS
  • GC-MS
  • DSC
  • GC-HS
  • PSD
  • GC
  • TGA
  • IR
  • UV
  • Polarimetry
  • Autotitrator
  • Wet chemical techniques
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