ANALYTICAL CAPABILITES, FACILITIES, AND INSTRUMENTATION
Within more than 10,000ft2 of laboratory space incorporating wet chemistry, stability, and instrumentation laboratories, the Apotex Pharmachem Inc. Analytical team performs a wide range of activities in accordance with ICH requirements, including:
- Analytical method development, validation and specification development
- Stability studies
- Informational Process R&D sample analysis
- Full quality testing as per material specifications and world-wide regulatory requirements
In-house analytical instrumentation includes:
- UPLC
- HPLC (UV/RI/Fluorescence/ELSD/MS Detection)
- SE/GPC Chromatograph
- GC: Headspace, Direct Injection, TCD, FID, MS
- ICP-OE Spectrometer
- Elemental Combustion Analyzer
- Ion Chromatograph
- Laser Diffraction Particle Size Analyzer
- Differential Scanning Calorimeters (DSC)
- Thermogravimetric Analyzer (TGA)
- FT-IR Spectrometer
- Optical Polarimeter
- Capillary Electrophoresis System
- UV Spectrophotometer
- Powder X-Ray Diffractometer