Structural chemistry

We utilize state-of-the-art instrumentation for characterization of pharmaceutical entities, elucidation of chemical structures, and analysis of extractables/leachables.

Materials characterization:

• Extractables characterization
  • Controlled extraction studies per FDA guidances
  • Polymer additive identification
  • Toxicological assessments including USP <87>
• Residual and casting solvent identification
  • USP <467> and related methods
  • Headspace GC-MS
• Identification and purity of polymers
  • Thermal analysis
  • Fourier transform infrared spectroscopy (FT-IR)

Trace organic analysis:

• Extractables routine control methods
  • Metered dose inhaler valve components and canisters
  • Dry powder inhaler devices
  • Blister-packs
  • Elastomeric closures including USP <381>
  • Blow/Fill/Seal packaging
  • Containers including USP <661>
• Leachables
  • Stability protocols
  • “In-use” study designs
  • Targeted profiling using GC-MS and LC-MS
• Migration studies
• Trace level impurity control
• N-nitrosamines
• Polynuclear aromatic hydrocarbons (PNAs)
  • Single-ion-monitoring GC-MS
• Residual solvents
  • API
  • Packaging

Impurities and degradation chemistry:

• Forced (Stressed) API and drug product degradation
• Impurity profiling
  • Mass spectrometry (LC-MS, LC-MS, GC-MS)
  • High resolution accurate mass LC-MS
  • Nuclear magnetic resonance (LC-NMR)
• Degradant and impurity isolation and characterization
• Semi preparative chromatography
• Reference standard synthesis / qualification
• Mechanistic evaluation of impurity formation

NMR and organic spectroscopy:

• Purity assays for release testing by NMR
  • Purity assay by USP <761>
  • USP poloxamer testing
• FT-IR method development/validation
• Process analytical support
• Quantitative analysis of the composition of polymers
• Method development and analysis using multivariate techniques
• Structure determinations
  • Proof-of-structure for small molecules (cGMP)
  • Proteins
• Analysis of impurities in formulated pharmaceuticals
  • LC-NMR
  • Nanoprobe NMR
• Analysis of metabolites of pharmaceutical ingredients
  • Metabonomics

Biopharmaceutical characterization:

• Amino acid analysis
• Peptide / protein sequencing
• Proteolytic mapping
• Disulfide bond mapping
• High-order structure characterization
• Identification / characterization of post-translational modifications

Computational chemistry:

• Energy minimized structures
• Physical property prediction

For capabilities that meet your needs, and outcomes that exceed your expectations, call Catalent today. For more information, please fill out our contact us form or call a member of our sales staff at +1 866.720.3148.