We have extensive capacity to support your development project.

• High Pressure Liquid Chromatography (HPLC)

  • Over 100 HLPC units in operation
  • Stability-indicating gradient HPLC methods for drug substances and drug products
  • Isocratic HPLC methods to support nonstability-indicating tests (Dissolution, Content Uniformity)
  • Chiral, Gel Permeation, Reversed-phase, Normal-phase, Ion-pairing, and Ion Exchange separations
  • Forced degradation studies
  • UV/VIS (including PDA), Refractive Index, Evaporative Light Scattering, and Mass Spectroscopic detection
  • Agilent 6530 Accurate Mass Q-TOF equipped with ESI and APCI for MS and MS/MS analyses

  

• Ultra-Performance Liquid Chromatography (UPLC)

  • Development of rapid UPLC methods including conversion of traditional methods to UPLC
  • Systems include Waters Acquity H-Class and Shimadzu Prominence UFLC
  • Refractive index measurement, UV, fluorescence, CAD, conductivity, and diode-array detection

• Gas Chromatography (GC)

  • Residual Solvents methods (compendial and non-compendial) for drug substances, raw materials, and drug products
  • Assay methods for non-solvent volatile impurities and intermediates
  • Headspace and direct injection sample introduction for packed and capillary columns
  • Flame Ionization (FID), Thermal Conductivity (TCD), and Mass Spectroscopic (MS) detection

  

• Ion Chromatography (IC)

  • Analysis of inorganic cations and anions; organic acids and bases; as well as amino acids and proteins
  • Analysis of mono-, di-, oligosaccharide, polysaccharide and their derivatives
  • Multiple Dionex Ion Chromatographic HPLCs available with Conductivity and Amperometric detection