Quantitative Analysis of Polysorbate 20/80 in Protein-Based Biopharmaceuticals Using A One-Pot RPLC-MS Based Platform Method

[ APPLICATION NOTE ] An Efficient UV-Based Method for the Assessment of Oleic Acid Content in Biotherapeutic Drug Products Containing Polysorbate-80 Robert E. Birdsall and Ying Qing Yu Waters Corporation, Milford, MA, USA APPLICATION BENEFITS ■■ ■■ A robust and…

Application Note Comparing ELSD and CAD Performance on Polysorbate Quantification in Infliximab Drug Products Duanduan Han, Robert E. Birdsall, Jennifer Simeone, Michael Fogwill, Ying Qing Yu Waters Corporation Abstract This application note reports a baseline subtraction processing method in Empower…

QUALITY ASSESSMENT OF POLYSORBATES 80 AND 20 PHARMACEUTICAL RAW MATERIALS BY MEASURING FATTY ACIDS COMPOSITION USING HPLC WITH MASS DETECTION Authors: Margaret Maziarz, Paul Rainville, Isabelle VuTrieu, Andrew Leightner Affiliations: Waters Corporation, Milford, MA The U.S. Pharmacopoeia specifies a gas…

DETERMINATION OF FATTY ACIDS COMPOSITION IN POLYSORBATES 80 AND 20 PHARMACEUTICAL RAW MATERIALS BY HPLC WITH MASS DETECTION Authors: Margaret Maziarz, Paul Rainville Affiliations: Waters Corporation, Milford, MA, USA 100% water INTRODUCTION 1 M NaOH Intensity 0 0 1 M…