Diane Diehl | Authors

Mass spectrometry (MS) is emerging as a critical tool in biopharmaceutical late stage development, manufacturing, and quality control (QC) environments. The rapid growth of biologics in development, the increasing demand for more robust analytical technologies to directly monitor the critical quality attributes (CQAs) of these new drugs, and longer term industry initiatives aimed at improving quality and productivity, such as quality by design (QbD) regulatory submissions and continuous manufacturing, are all fueling a greater need for mass monitoring with MS.

This method is rapid and sensitive for the analysis of melamine and cyanuric acid simultaneously in infant formula. Using two Oasis solid-phase extraction protocols and the ACQUITY UPLC, the results are consistent with the published US FDA interim method, while demonstrating a reduced analysis time.