Analytical Characterization

Solvias offers characterization of new drug substances to meet the regulatory requirements for registration dossiers from physico-chemical parameter evaluation and preformulation up to the setting up of complete analytical test programs. Typical services include, but are not limited to:

  • Elemental composition and impurities
  • Solubility (aqueous and non-aqueous)
  • pKa
  • Partition coefficient
  • Spectroscopic characterization (MS, NMR, IR, UV)
  • Compatibility with typical excipients and packaging material
  • Particle size analysis
  • Initial stability
  • Solid-state properties
  • Identification and quantification of impurities
  • Various techniques such as microtitration. These are available to reduce the required amount of precious samples

The details of each program are mutually agreed with the customer. Solvias can advise customers who wish to put together a specific characterization that will satisfy the requirements of the regulatory authorities.

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HPLC determination