API Characterization
A thorough API characterization of the physical and chemical properties is a regulatory requirement and a vital step in drug development. An understanding of API characterization results in control on the quality of the product throughout the process.
Our Services
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.
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