Almost all analytical testing of clinical and commercial injectable products is done by our in-house staff. With well-equipped, on-site analytical and microbiological laboratories as well as stability chambers, our scientists monitor end-to-end processes to confirm the safety and quality of each batch.
Analytical Services
We bring extensive experience to your project across all stages to ensure that what you specify is what is delivered.We do this by implementing a variety of phase-appropriate assays to test your products and materials, in-process and for final release.
Testing Capabilities:
Biological Testing:
- Sterility (state-of-the-art isolator technology)
- Bacterial endotoxins
- Culture purity
- Microbial enumeration / titer
- Monocyte activation test
- Culture media growth promotion
- Imaging microscope
- Comprehensive cleanroom support
Analytical Testing:
- Gas chromatography (GC)
- HPLC / UPLC – including UV/VIS, PDA, RI, ELSD, MS, MALS
- Capillary electrophoresis
- SDS-PAGE gel electrophoresis / Western blot
- FT-infrared spectroscopy (FT-IR)
- UV-visible spectroscopy (standard and variable path length)
- Osmometry
- pH
- Conductivity
- Near-infrared spectroscopy (NIR)
- Titration
- Karl Fischer
- Total organic carbon
- Custom dissolution
- ELISA / multi-modal plate reader
- Raman spectroscopy
Physical Testing:
- Rotational viscosity
- Rheometry
- Differential viscosity
- Polarimetry
- Density
- Extrusion force
- Delivered volume / volume in container
- Turbidity
- Leak detection
- Refractive index
- Liquid particle counting – light obscuration and microscopic