MODERNIZATION OF AN ANTIVIRAL IMPURITIES MONOGRAPH USING THE GLOBALLY HARMONIZED PHARMACOPEIAL GUIDANCE FOR LIQUID CHROMATOGRAPHY

LIQUID CHROMATOGRAPHIC GRADIENT METHOD ALLOWANCES PROVIDED BY GENERAL CHAPTER, USP CHROMATOGRAPHY <621> Catharine E. Layton, Paul D. Rainville Waters Corporation, 34 Maple St., Milford, MA, USA INTRODUCTION The U.S. Pharmacopeia (USP) portfolio of solutions addresses quality assurance, enhances regulatory predictability,…

Application Note Achieving Method Modernization with the New Liquid Chromatographic Gradient Allowances Provided by USP General Chapter <621> Chromatography and the Alliance™ iS HPLC System Catharine E. Layton, Paul D. Rainville Waters Corporation This is an Application Brief and does…

[ APPLICATION NOTE ] Scaling of a USP Assay for Quetiapine Fumarate Across Different Liquid Chromatographic Systems Amanda B. Dlugasch, Jennifer Simeone, and Patricia R. McConville Waters Corporation, Milford, MA, USA APPLICATION BENEFITS ■■ ■■ The Waters Column Calculator enables…

Liquid Chromatographic Gradient Method Allowances Provided by General Chapter, USP <621> Chromatography Catharine E. Layton, Paul D. Rainville Waters Technologies Corporation, 34 Maple St., Milford, MA, USA Introduction Discussion The U.S. Pharmacopeia (USP) portfolio of solutions addresses quality assurance, enhances…