Particle size and particle size distribution are among the critical quality parameters that directly influence the physical properties, manufacturability, stability, and performance of pharmaceutical products.
Changes in particle size may lead to variations in critical product characteristics, including surface area, dissolution behavior, flow properties, homogeneity, and bioavailability.
Particle size analyses can be performed as part of product development and quality control studies for a wide range of sample types, including active pharmaceutical ingredients (APIs), excipients, powder formulations, suspensions, and emulsions.
At WMINOLAB Innovation Laboratory, particle size and particle size distribution are analyzed using the Malvern Panalytical Mastersizer 3000+ system based on Laser Diffraction technology.
The system measures the light-scattering behavior of particles at different angles to determine particle size distribution, providing rapid, accurate, and reproducible results across a broad particle size range.
- D10: The particle size below which 10% of the particles are found
- D50: The median particle size, below which 50% of the particles are found and above which the remaining 50% are found
- D90: The particle size below which 90% of the particles are found
Various particle size parameters can be evaluated.