AN EFFICIENT METHOD FOR THE DETERMINATION OF TRACE EXCIPIENT IMPURITIES IN BIOTHERAPEUTIC DRUG PRODUCTS CONTAINING POLYSORBATE

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 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 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 Biopharma/Pharma Shining Light on Polysorbate Hydrolysis by LC/ELSD Featuring the Agilent AdvanceBio Surfactant Profiling HPLC column Authors Abstract Chenchen He, Wendi A. Hale, Andrew Coffey, Andrea Angelo P. Tripodi, and Amanda McQuay Agilent Technologies, Inc. Polysorbates are surfactants…