Chemically Specific API Particle Sizing Using Automated Raman Spectroscopy

Authors & ContributorsDavid Exline

June 05, 2018

The active pharmaceutical ingredient (API) size distribution within the final formulation of a drug product is critical as it relates to bioavailability, rates of absorption, and stability of that drug product. Due to the potential significant impact related to the active pharmaceutical ingredient (API) size and shape, gaining an understanding of this information is of great importance to regulatory agencies, specifically when it relates to in vitro bioequivalence studies.