Successful Global Cross Lab Method Transfer of a USP Organic Impurities Method to an Arc HPLC Using a Risk-based Approach

Application Note Case Study: Investigating Unexpected Results of a Global Cross-Laboratory Study of a USP Organic Impurities Method on an Arc HPLC System Amanda B. Dlugasch, Tran Pham, Paula Hong Waters Corporation Abstract In a global economy many laboratories need…

EMPLOYING MODERN LIQUID CHROMATOGRAPHY TECHNOLOGY TO SCALE A USP GRADIENT METHOD ON A SINGLE LIQUID CHROMATOGRAPHIC SYSTEM Amanda B. Dlugasch, Jennifer Simeone, Paula Hong and Zhimin Li Waters, Corporation. Milford, Massachusetts, USA INTRODUCTION The continual development and modernization of pharmaceutical…

[ APPLICATION NOTE ] Gradient Method Scaling for Life Cycle Management of a USP Impurities Method Amanda B. Dlugasch, Jennifer Simeone, and Patricia R. McConville Waters Corporation, Milford, MA, USA APPLICATION BENEFITS ■■ ■■ The Waters™ Columns Calculator enables Pharmaceutical…

[ APPLICATION NOTE ] Demonstration of the USP Quetiapine Fumarate Impurities Method Across a Wide Range of Liquid Chromatographic Systems Amanda B. Dlugasch, Jennifer Simeone, and Patricia R. McConville Waters Corporation, Milford, MA, USA APPLICATION BENEFITS ■■ ■■ The USP…