Analytical development
SEPS Pharma offers a wide range of analytical tools and services to characterize pharmaceutical dosage forms, and assess the (long-term) chemical and physical stability of active pharmaceutical ingredients in drug products.
SEPS Pharma has a high level of expertise in analytical method development, and physical/chemical characterization of liquid and solid drug formulations. Using state-of-the-art equipment, we provide innovative solutions to enable the analysis of biomolecules and small synthetic molecules of therapeutic interest.
The following analytical capabilities are available to support formulation development:
- In-process control:
- pH
- Viscosity
- Density
- Hardness
- Friability
- Desintegration time
- Rheology
- Stability studies:
- Forced degradation and photostability studies
- Excipient compatibility studies
- Accelerated stability studies
- In-use stability studies
- Chromatographic method development and analysis:
- Assay and purity indicating high-performance liquid chromatography (HPLC) methods (reversed-phase, HILIC, SEC,…)
- Enantioselective HPLC methods
- Volatile organic impurity and residual solvent analysis by (headspace) gas chromatography (GC)
- Moisture determination:
- Karl Fischer titration
- Loss-on-drying
- Dissolution studies
- Thermal analysis
- Differential scanning calorimetry (DSC)
- Modulated DSC (mDSC)
- Spectroscopic analysis:
- Ultraviolet (UV) spectroscopy
- Fourier-transform infrared spectroscopy (FT-IR)
- X-ray diffraction spectroscopy (XRD)
- Particle size distribution analysis:
- Sieve analysis
- Laser diffraction
- Scanning electron microsopy (SEM)
- Zeta-potential measurement