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