An Efficient UV-Based Method for the Assessment of Oleic Acid Content in Biotherapeutic Drug Products Containing Polysorbate-80

AN EFFICIENT METHOD FOR THE DETERMINATION OF TRACE EXCIPIENT IMPURITIES IN BIOTHERAPEUTIC DRUG PRODUCTS CONTAINING POLYSORBATE Robert Birdsall, Brooke Koshel, Ximo Zhang, Scott Berger, Ying Qing Yu Waters Corporation, Milford, MA RESULTS INTRODUCTION Figure 2. Dynamic range and internal standard…

AN EFFICIENT METHOD FOR THE DETERMINATION OF TRACE EXCIPIENT IMPURITIES IN BIOTHERAPEUTIC DRUG PRODUCTS CONTAINING POLYSORBATE Robert Birdsall, Brooke Koshel, Scott Berger, Ying Qing Yu, and Weibin Chen Waters Corporation Milford, MA INTRODUCTION RESULTS AND DISCUSSION Polyoxyethylene sorbitan-based nonionic surfactants…

[ APPLICATION NOTEBOOK ] ACQUITY QDa Detector QC APPLICATIONS COMPENDIUM EDITION 2 Dear Colleague The 2013 introduction of the ACQUITY™ QDa™ Detector was a breakthrough in Chromatography and Mass Spectrometry integration. It was the fulfilment of a vision 20 years…

Application Note Quantitative Analysis of Polysorbate 20/80 in Protein-Based Biopharmaceuticals Using A One-Pot RPLC-MS Based Platform Method Robert E. Birdsall, David Dao, Brooke M. Koshel, Ying Qing Yu, Aude Smeets, Michel Gerodez, Xavier Taillieu Waters Corporation, GlaxoSmithKline Abstract A high…