Analytical Services

CapEval Pharma can provide analytical strategies in accordance with ICH standards and develop approaches for pre-clincial and clinical product development. 

We can help in the following areas:

  • Method development for API, impurities, genotoxic impurities
  • Development of validation protocols according to clinical phase or to ICH standards
  • Development of stability indicating methods
  • Impurities analysis -related substances, degradants and qualification
  • Reference standard qualification
  • Stability testing and data interpretation
  • Analytical method transfer and validation
  • Quality control
  • Setting specifications
  • Rapid bioanalysis – solid method development/sample analysis for complex approaches (e.g. cassette PK, tissue analysis)
  • GLP bioanalysis – method development/sample analysis under compliance with focus on ruggedness
  • Metabolite identification and bio-synthesis approaches

Specialities and Expertise:

  • Chromatographic separation (GC, HPLC, IC) and derivatization methods
  • ICP
  • Identification tests (NMR, IR, MS)
  • GC/MS and LC/MS technologies (triple quad, ion trap, TOF)
  • Genotoxic impurities
  • Polymorphic studies
  • Lipid analysis (total and free cholesterol, bile acids)
  • Isolation/characterization of metabolites using radiolabels