Analytical Services
- Analytical method development
- Analytical method validation, verification and transfer
- Nitrosamine and genotoxic impurity control testing and consulting
- Photostability and forced degradation studies
- Drug–excipient compatibility studies
- Impurity identification studies
- Custom impurity reference standard standardization
- Intrinsic solubility studies
- Equilibrium solubility studies for BCS-based biowaivers
- IVRT method development and analysis
- Rheological behaviour
- Specific surface area determination
- Oxygen determination in the free volume of vials
- Osmolality analysis
- Particulate contamination testing (visible and sub-visible particles)
- Thermal cycle studies (freeze–thaw and cool–thaw cycles)
- Stability studies (accelerated, intermediate, long-term, in-use)
Available Equipment
- Spectrometers (FTIR, UV)
- Refractometer
- Polarimeter
- Melting point apparatus
- Differential scanning calorimetry (DSC)
- Powder X-ray diffractometer (XRD)
- Nuclear magnetic resonance (NMR)¹
- HPLC systems (UV, PDA, RI), UPLC systems (UV, PDA, MS/MS)
- GC systems (FID, HS-FID, TCD, MS, HS-MS)
- Electrophoresis system
- Potentiometric titrator
- Karl Fischer titrator and coulometer
- Xenon lamp photostability chamber
- Laser diffraction particle size analyser (PSD)
- IVRT diffusion system
- Rheometer
- Dissolution systems (online/offline)
- BET specific surface area analyser
- Filter integrity testers (Pall Flowstar, Sartorius)
- Osmometer
- Liquid particle counter
- Turbidimeter
- Optical oxygen meter
