Methodological validation of microbial limit tests for high-viscosity and common pharmaceutical excipients.

Abstract

Microbial contamination of pharmaceutical excipients remains a critical precursor to finished product failure, which necessitates rigorous microbial limit testing of pharmaceutical excipients. However, high-viscosity excipients present distinct analytical challenges, including hygroscopicity, swelling upon hydration, and agglomeration. These physicochemical properties often impede sample homogenization, obstruct membrane filtration, and compromise microbial recovery. To address these limitations