In this application note, Malvern Panalytical demonstrates the ability of the Mastersizer 3000 and Aero S dispersion unit to detect a small proportion of anomalously large particles added to a small aliquot in a seeding experiment.

The company has chosen a fine grade of lactose as a model for pharmaceutical active pharmaceutical ingredients (API) or excipient powders.

This lactose has a Dv (50) of 4µm. The anomalous particles will be a known sample of glass beads with a Dv (50) of 62µm, Malvern’s Quality Audit Standard (QAS).