| Laboratory rooms designed for efficient workflow |
- Dedicated analytical balance room
- Four (4) chemical hoods per area
- Millipore water system
- Movable laboratory benches
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Chromatography Capabilities |
- Infrastructure for CDAS
- 60 HPLC’s
- 9 Gas Chromatographs
|
Dissolution Testing Capabilities |
- 70 dissolution baths
- 12 dissolution auto samplers
- Two disintegration units
- Fiber-Optic dissolution systems
|
Three glassware washer machines |
Support instrumentation |
- UV/VIS, FTIR, Particle size analyzers, KF, TOC
|
| Analytical Development Laboratory |
- Instrumentation Qualification Fully cGMP Compliant
- Regional Microscopy Center of Excellence
|
Technology |
- Scanning Electron Microscopy / Energy Dispersive X-Ray Spectrometry
- Raman / Fluorescence Microscope
- FTIR / NIR Microscope
- Polarized Light Microscope
- FT-Raman
- Powder X-Ray Diffraction (Bruker D4 and D8)
- Differential Scanning Calorimetry
- LC-MS / MS
- Fraction Collector
- Bruker Multi Purpose FT-NIR Analyzer
- Ultra-Fast Chromatography – UPLC
- Ion Mobility Spectrophotomer
|
Analytical support (significant areas) |
- Process validation
- Manufacturing investigations
- Analytical transfers leadership
- Development / implementation of new technologies
- Global technology transfers
- Product transfers
- Regulatory submissions
|
