Successful Global Cross Lab Method Transfer Of A USP Organic Impurities Method To An Arc HPLC Using A Risk-based Approach

By Amanda B. Dlugasch, Paula Hong

In a global economy, there is often a challenge to implement and maintain a competitive advantage. New instrumentation is desired, as it may provide improvements in both performance and usability. To integrate new instrumentation, it is important to harmonize the approach across many sites and to control for method and other variables from one laboratory to another. To address these challenges, it is advisable to use a risk-based approach and control strategy.

Learn how, through this interlaboratory study and the adoption of a risk-based approach to method transfer, we were able to successfully replicate USP monographs globally on the Waters Arc HPLC System.