Physicochemical Characterization
A thorough API characterization of the physical and chemical properties is a regulatory requirement and a vital step in drug development. Neglecting timely physicochemical characterization often results in disastrous consequences for both the project economics and timeline. Only with a solid understanding of the API characterization, one can have control on the quality of the product throughout the process. Without this basic knowledge, it will be difficult to evaluate and respond to the challenges that arise later.
Our state-of-the-art instrumentation combined with the expertise of our highly qualified scientists provides a thorough understanding of physicochemical characteristic of the API as well as advanced intermediates. Our complete physicochemical characterization of the APIs includes:
- Powder X-ray Diffraction (PXRD)
- Particle Size Distribution (PSD)
- Dynamic Vapor Sorption (DVS)
- Differential Scanning Calorimetry (DSC)
- Thermogravimetric Analysis (TGA)
- Scanning Electron Microscopy (SEM)
- Energy Dispersive X-ray Spectroscopy (EDS)
- Attenuated Total Reflection IR Spectroscopy (ATR-IR)
- Raman Fiber-Optic Spectroscopy
- Nuclear Magnetic Resonance (NMR)
- Polarized Light Microscopy (PLM)
- Loss on Drying (LOD)
- Refractive Index Measurement (RI)
- Solubility
Clients may choose some or all of these characterizations to be performed on their API based on their needs and availability of the material.
Related instruments: D8 Discover™, D2 Phaser™, DVS Resolution1™, Phenom ProX™, Mastersizer 3000™, Excellence R4™, Nicolet iS5™, BA310 Microscope, TA Q200™, TA Q500™, Crystal16™
