Global Cross Lab Method Transfer of a USP Impurities Method on the Alliance™ iS HPLC System

Implementing and maintaining a competitive advantage is an ever-present challenge in a global economy. For analytical laboratories, this can be accomplished by achieving improvements in both performance and usability through the use of modern High Performance Liquid Chromatography (HPLC) instrumentation. Assessment of a new HPLC instrumentation platform to understand the various system configurations is important to achieving successful results. Another key aspect to reduce the variability from one laboratory to another is to understand specific method conditions and other variables that can impact chromatographic reproducibility. To address these challenges, a solid understanding of variables that can impact method performance should be assessed.
Afterward, control strategies to minimize the risks can be implemented. In this application note, a global interlaboratory method transfer of a USP organic impurities method was conducted across eight sites with the Alliance iS HPLC System. The method transfer process was multi-faceted in which control strategies were developed from a risk-assessment that delivered a standard operating procedure (SOP) from the sending laboratory site to the receiving laboratories. With these control strategies, the system and method variables were controlled resulting in a successful global method transfer.