Analytical Methods

Spectroscopy

  • FTIR 
  • UV-VIS 
  • NIR

Chromatography

  • HPLC (UV, DAD, Fluorescence, MS)
  • Semi-preparative HPLC for separation of substances for structure determination and method development
  • GC (FID)
  • GC-Headspace
  • TLC

Miscellaneous pharmacopeia standard tests (PharmEur, USP), i.e.

  • water determination (Karl-Fischer, titrimetric)
  • optical rotation
  • loss on drying
  • sulphated ash/ residue on ignition
  • melting point

General API property determination such as solubilities, pKa, log P, permeability etc. (CTD module 3 chapter 3.2.S.1.3 and IMPD 2.2.1.S.1.3)

Solid-State Characterisation

  • DSC (differential scanning calorimetry)
  • microscopy / thermomicroscopy / imaging analysis
  • Particle size distribution by laser diffraction (wet / dry dispersion)
  • Crystal density (gas pycnometry)
  • determination of special solid state parameters such as aggregate density, dispersion analysis, sedimentation / flocculation analysis
  • XRPD*
  • RAMAN methods*
  • BET (surface determination)*
  • iGC (inverse GC)*

*External methods

Further methods on request