Structural Characterization

Our expertise encompasses the full range of large and small molecules

Catalent offers fully-validated, GMP Nuclear Magnetic Resonance (NMR) and Mass Spectrometric (MS) services, as well as other spectroscopic and thermal techniques.  Our expertise encompasses the full range of large and small molecules, including peptides, oligonucleotides, oligosaccharides, steroids, alkaloids, and other complex small molecules.  Typical applications include impurity identification, reference standard characterization, release testing and quantitative method development and validation.

Impurity Identification
  • Synthetic impurities
  • Degradation products (API and drug product)
  • Leachables
  • Applicable instrumentation
    • Waters Xevo G2-S QToF mass spectrometer with Waters ACQUITY UPLC
      • High sensitivity and enhanced dynamic range capabilities for accurate mass analysis (<1 ppm) of a broad range of compounds (large and small molecule)
    • Agilent 6520 QToF mass spectrometer
    • High through-put instrument with ESI and APCI functionality
    • ThermoScientific LTQ mass spectrometer capable of MSn structural analyses
    • Variety of single quadropole mass spectrometers for nominal mass determination
    • 500 MHz Agilent DD2 NMR spectrometer with  vnmrj 3.2 SE for secure environments
      • Multiple direct and indirect probes for the analysis of a full range of active nuclei
      • Standard 1D, 2D, and 3D experiments
    • LC-NMR analysis is available for specific applications
Reference Standard Characterization
  • API
  • Metabolites
  • Impurity markers
  • Applicable instrumentation
    • Agilent 6520 mass spectrometer or Waters Xevo G2-S QToF for accurate mass
    • ThermoScientific LTQ mass spectrometer capable of MSn structural analyses
    • 500 MHz Agilent DD2 NMR spectrometer with  vnmrj 3.2 SE for secure environments
    • ThermoElectron Nicolet 6700 FTIR spectrophotometer
    • TA Instruments Q200 DSC and Q500TGA
    • All standard chromatographic and compendial tests for purity determination
Release Testing
  • API identity confirmation
  • Compendial(USP, EP, JP, etc.) testing
  • Drug product testing
  • Applicable instrumentation
    • ThermoScientific LTQ mass spectrometer for mass confirmation
    • 500 MHz Agilent DD2 NMR spectrometer with  vnmrj 3.2 SE for secure environments
    • ThermoElectron Nicolet 6700 FTIR spectrophotometer
    • TA Instruments Q200 DSC and Q500TGA
    • All standard chromatographic and compendial tests for purity determination
Quantitative Method Development and Validation
  • NMR
    • Absolute quantitation for small molecules
    • Limits testing for residual solvents and other impurities
    • Quantitative isomeric content determination
  • MS
    • Complex matricies
    • Low-level genotoxic impurities
  • Lyophilization cycle design (DSC)
  • Polymer identification (FTIR or NMR)
  • Catalent also offers particulate identification using FTIR- and Raman-microscopy.