We offer a comprehensive package of analytical services to support your product development and marketed product activities.
From rapid testing of early candidates to New Drug Application (NDA) submission, Catalent Pharma Solutions help accelerate your efforts by providing immediate resourcing and technical expertise support for your product.
Analytical services:
- Rapid Microbial Methods (RMM) and Phase I sterile clinical supply manufacturing
- Characterization services
- Excipients
- Proof of structure
- Establishment of purity as well as release
- Specification development for excipient-masking transformations
- Packaging components
- Physico-chemical testing
- Moisture permeability
- Container-closure integrity evaluations
- Extractables/leachables determinations
- Finished pharmaceutical products
- Method development activities to support deformulation studies and determination of active/excipient ratios
- Excipient identification and quantitation
- Method development
- Solid oral - assay, impurities, dissolution, disintegration, moisture, hardness, friability, content uniformity, and cleaning methods.
- Liquid oral - assay, impurities, dose uniformity, osmolalility, viscosity, pH, and cleaning methods.
- Inhalation - dose content uniformity, shot weight, particle size, spray pattern, plume geometry, assay, impurities, moisture, leak rate, extractables, and microbial methods.
- Topical - assays, impurities, pH, viscosity, dissolution, moisture, and microbial methods.
- Sterile - assay, impurities, pH, microbial, and sterility as well as process validation support for water systems.
- Process validation
- Microbiological testing
- Mass spectrometry
- Chemical development
- Drug substance testing
- Elucidation of structure
- Assignment of purity
- Polymorphism evaluations
- Phase solubility studies
- Impurity profiling (including stereoisomers)
- Preparatory scale-up separations
- Isolations
- Purifications
- Structure elucidation
- Purity assignment
- Biopharmaceuticals
Testing capabilities:
- Pharmaceutical analysis
- Metal analysis
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
- Inductively Coupled Plasma Atomic Emmision Spectrometry (ICP-AES)
- Graphite Furnace Atomic Absorption Spectrometry (GFAAS)
- Cold Vapor Atomic Absorption Spectrometry (CVAAS)
- Flame Atomic Absorption Spectrometry (FAAS)
- Chromatography
- HPLC
- GC
- Chiral HPLC
- TLC
- CE
- Semi-Prep LC
- Compendial testing
- UV-VIS spectrophotometry
- Mass spectrometry (GC/MS and LC/MS)
- Dissolution/disintegration
- Physical testing
- DSC/TGA
- Trace analysis
- Fourier Transform Infrared Spectrophotometry (FTIR)
- Polarimetry
- Particle size analysis (Malvern, Microscopy, Sieving, HIAC, Cascade Impaction)
For capabilities that meet your needs, and outcomes that exceed your expectations, partner with Catalent today. For more information fill out our Contact us form or call a member of our sales staff toll-free at 866.720.3148.