The United States Pharmacopeia (USP) champions pharmacopeial harmonization and modernization efforts, and international organizations are following suit. As a result, the USP encourages updating older compendial methods to ensure they are fit for purpose. Revisions to guidelines give drug developers more flexibility in modifying existing pharmacopeial methods. This helps leverage more modern techniques and technologies, and in some cases avoids revalidation.
The Stages of Method Lifecycle Management
Methods with greater agility, robustness, and capacity for change can help reduce regulatory burden, failure risk, and costs. Discover the stages, concepts, and terms that define lifecycle management, then explore them in depth below.
Method Modernization in Depth
In this study, the USP impurity monograph for quetiapine fumarate will be analyzed on the ACQUITY Arc System and then scaled to smaller particle sized columns using the Waters Columns Calculator.
Dr. Leonel Santos and Dr. Horacio Pappa provide an overview of the USP's pharmacopeial harmonization and modernization efforts, including changes described in the pending USP General Chapter <621> on chromatography. Amanda Dlugasch from Waters presents a case study, which leverages USP <621> allowable adjustments to illustrate the benefits of modernizing methods without the need to revalidate.
In this study, the Waters Columns Calculator will be used to scale the USP monograph assay method for quetiapine fumarate.