This function focuses on the physical characterization of APIs and intermediates, including polymorphism, crystallinity, and particle size, which are critical for solubility, stability, manufacturability, and bioavailability. Solid-state insights guide formulation development, process optimization, and regulatory compliance.
Key Deliverables
- Polymorph & Crystallinity Analysis: Using X-ray powder diffraction (XRPD), DSC, and thermal analysis to identify solid forms.
- Particle Size Distribution (PSD): Measuring particle size and distribution using laser diffraction, dynamic light scattering, or sieving techniques.
- Morphology & Surface Characterization: Assessing particle shape, surface area, and porosity via microscopy and BET analysis.
- Stability & Processability Studies: Evaluating solid-state properties under stress conditions to guide formulation and manufacturing.
- Regulatory Documentation: Providing reports and data for IND, NDA, ANDA, DMF filings, and quality dossiers.
- Support for Scale-up & Manufacturing: Ensuring consistent physical properties for reproducible API performance in downstream processes.