Quality Control

The Quality Control (QC) laboratory directly adjacent to our Chemical GMP Synthesis Facility is overseen by an independent quality assurance manager.

Infrastructure:
 

  • Dedicated analytical laboratory
  • Equipped with qualified and validated instrumentation for the GLP/GMP release and characterization of APIs

QC Analysis of Intermediates, Drug Substances (DS) and CoA Release:
 
  • Identity
  • 1H-,13C-NMR
  • HRMS, MSn
  • UV-Vis spectroscopy
  • IR spectroscopy
  • Refractive index
  • Optical rotation
  • Melting point
     
  • Purity
    • Chemical purity
    • Related substances

       
  • Quality Tests
    • Heavy metals
    • Organic volatile impurities
    • Loss on drying
    • Residue on ignition
    • pKa determination
    • Raw materials release
       

Other Services:
 

  • Mass Spectrometry/NMR Spectrometry
    • Structural confirmation of API and intermediates
    • Structural determination of trace impurities
       
  • Release Testing for Oliogonucelotides/siRNA/Aptamers/Peptides