Global Cross Lab Method Transfer Of A USP Impurities Method On The Alliance™ iS HPLC System

By Amanda B. Dlugasch and Paula Hong

In a global economy, implementing and sustaining a competitive edge is a constant challenge. One way to gain this edge for analytical laboratories is by enhancing performance and usability through the utilization of advanced High-Performance Liquid Chromatography (HPLC) instruments. Evaluating a new HPLC platform to understand its various configurations is crucial to ensure successful outcomes. Additionally, minimizing variability between different laboratories requires a thorough understanding of specific method conditions and other factors that affect chromatographic reproducibility.

To overcome these challenges, the variables affecting method performance should be evaluated. Following this, control strategies can be implemented to mitigate associated risks. In this application note, a global interlaboratory method transfer of a USP organic impurities method was conducted across eight sites using the Alliance iS HPLC System. The multi-faceted method transfer process involved control strategies derived from a risk assessment that led to the development of a standard operating procedure (SOP) that was shared from the originating laboratory to the receiving laboratories. By implementing these strategies, both system and method variables were effectively controlled, resulting in a successful global method transfer.