Confarma

Analytical characterization

Solvias characterizes drug substances to meet regulatory requirements for your registration dossiers. Analyses range from physico-chemical parameter evaluation and pre-formulation right up to the establishment of complete analytical test programs. We can support you on the specific characterization elements required to satisfy the requirements of the regulatory authorities.

Our analytical services include:

  • Elemental composition and impurities
  • Solubility (aqueous and non-aqueous)
  • pKa
  • Partition coefficient
  • Spectroscopic characterization (MS, NMR, IR, UV)
  • Excipient and packaging compatibility
  • Particle size analysis
  • Initial stability
  • Solid-state properties
  • Impurity identification and quantification
  • Other techniques e.g. microtitration to minimise sample use