Particle Size Distribution

Particle size distribution characterises formulation heterogeneity predicting bioavailability and formulation stability. Dynamic light scattering measures average particle size. Laser diffraction quantitates size distribution breadth. Transmission electron microscopy visualises individual particles. Bimodal distributions indicate formulation instability.

Regulatory specifications establish acceptable size ranges. Formulation variability warrant investigation. Manufacturing consistency ensures stable size distribution. Bioavailability assessment accounts for particle size effects. Post-approval monitoring confirms size maintenance.