Product Analysis

While ProSynth does not operate a fully GMP compliant facility, we do apply the concepts provided in Section 19 of the ICH Q7 document. Our procedures for production, analysis and storage are carefully documented to provide full traceability.

We use a wide range of analytical techniques for in-process and finished product examination. Many are performed in-house, or by Cambridge University under CDA.

  • Achiral & Chiral HPLC
  • GC FID
  • Automated determination of loss on drying
  • Moisture determination by Karl Fischer
  • Thin layer chromatography
  • ‘Wet’ analytical techniques such as titration
  • High Resolution Mass Spectroscopy
  • Nuclear Magnetic Resonance Spectroscopy (a range of nuclei)
  • X-Ray powder diffraction (XRPD)
  • Single crystal X-Ray diffraction
  • Infra-Red spectroscopy
  • Elemental analysis