Analytical services

Physico-chemical characterization including pharmaceutical products: 

  • Solution NMR spectroscopy (structure elucidation and impurity profiling)
  • Solid State NMR spectroscopy (Characterization of polymers, evaluation of crystalline and amorphous ratio, Identification and quantitation of polymorphs)
  • Molecular weight (SEC coupled with multidetector array; ESI-MS)
  • Particle size analysis (DLS with Zeta Potential evaluation)
  • Rheological properties (Rheometer measurements)
  • Liquid chromatography separation of complex mixtures followed by mass spectrometry detection (LCMS) ranging from small molecules to large biomolecules; molecular weight determination and/or confirmation; molecular formula calculation by high resolution MS as well as structure elucidation by tandem MS; identification of impurity and degradation products; data elaboration by newly-developed software for analysis of biopharmaceuticals.

Quality control testing of drug substances and drug products

  • Heparin and LWWH NMR identification tests according US, Europe and Japanese pharmacopoeias.
  • Development and validation of custom NMR based methods.
  • Heparin and LMWH Molecular weight determination according US and EU pharmacopoeias