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.