Impurity Isolation and Scale-up from UPLC Methodology: Analysis of an Unknown Degradant Found in Quetiapine Fumarate

I N T RO DU C T IO N A company that manufactures drug product or drug substance has a vested interest in determining the impurities associated with their compounds. The analysis of impurities can be a very labor-intensive task involving method development, impurity synthesis, isolation techniques, and various analytical approaches to determine the unambiguous identification of the impurity of interest. The lack of a pure impurity can delay a drug development program. Techniques concerning procurement of a targeted impurity are generally based on the project timelines. Impurity synthesis can be a time-consuming process requiring skilled synthetic chemists.