Preparation of Impurity-Spiked Good Laboratory Practice Toxicological Batches of Active Pharmaceutical Ingredient Using Resonant Acoustic Mixing

Gilead process chemistry has recently started to employ resonant acoustic mixing (RAM) technology to produce impurity-spiked good laboratory practice (GLP) toxicology batches of active pharmaceutical ingredient (API). When compared to other methods of generating impurity-spiked API, the benefits of this process are operational simplicity and reproducibility, solvent-free mixing and homogenization, ability to maintain the crystalline form of the API, and minimization of occupational exposure to powdered API. In this work, we describe a typical RAM process used to generate a GLP toxicology batch of API, including starting point instrument settings and the use of ceramic beads to homogenize material.