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