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