Analytical R&D and Quality Control

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Analytical R&D and Quality Control

Analytical Services

Our Analytical Research team provides all of the analytical needs for process development, GLP studies and GMP campaigns. In general, our service includes, but is not limited to, method development, method verification / validation, reference standard certification, release testing, and impurity separation and identification. We are skilled at HPLC / GC method development and validation, structural elucidation using LC-MS and NMR and stability studies as listed as below.


  • HPLC / GC method development for challenging separations including chiral separations
  • Method development and testing using LC/MS LC/CAD GC/FID GC/MS NMR TGA KF DSC FT-IR Polarimeter
  • Method transfer/validation
  • Reference standard certification
  • Separation and Characterization of impurities and degradants
  • cGMP release testing
  • cGMP raw material release testing
  • cGMP intermediate and API release testing
  • Stability studies: stability indicating method development and stability sample testing
  • Genotoxic impurity method development and testing
  • Forced Degradation Pathway Understanding
Analytical R&D and Quality Control 1

Analytical Equipment

Instruments Qualified / Calibrated for GMP Use
  • Agilent 1100 LC – UV systems
  • Agilent 1260 LC – UV systems
  • Thermo Dionex Ultimate 3000 HPLC / CAD & UV
  • Thermo SP 3000 HPLC ELSD / UV
  • Thermo Finnigan Surveyor MSQ Plus Mass Spectrometer
  • Agilent 6890 GC /FID with headspace and direct injection
  • Nicolet Avatar 360 FT-IR Spectrometer
  • OptiMelt Automated Melting Point
  • Metrohm 756 KF Coulometer with sample oven
  • Accumet XL-15 pH Meter
  • Mettler Toledo Micro-balance MT5
  • PerkinElmer 341 Polarimeter
  • 5 Stability Chambers as being set up at the following conditions: 5°C • 25°C/60% RH • 30°C/65% RH • 40°C/75% RH
  • Photostability Chamber

Analytical Equipment

Instruments for R&D
  • Varian Inova NMR Systems 300 and 400 MHz
  • Thermo Finnigan Surveyor MSQ Plus Mass Spectrometer
  • Thermo Ultimate 3000 HPLC CAD / UV
  • Agilent 6890 GC-MS
  • Agilent 5890 GC-FID systems
  • Melting Point Apparatus
  • Thermo SP 3000 HPLC-UV systems one with CAD / UV
  • Dionex Ion Chromatography

Analytical Equipment