Leveraging the Alliance™ iS Bio HPLC System as a Modern HPLC for Peptide Drug Substances Analysis in QC Environments

METHOD MODERNIZATION OF COMPENDIAL METHODS USING USP <621> WITH A NEXT-GENERATION HPLC SYSTEM Pawel Bigos, Duanduan Han, Xiangsha Du, Robert Birdsall, Karen Nyholm Waters Corporation 0.0000 10.0 0.0030 0.0025 0.0025 System Column Inj. Vol. Flow Rate Run Time Mobile Phase…

MODERNIZING BIOTHERAPEUTIC COMPENDIAL METHODS WITH A NEXT-GENERATION HPLC SYSTEM Pawel Bigos, Duanduan Han, Xiangsha Du, Robert Birdsall, Andrea Hoehnel, Karen Nyholm Waters Corporation INTRODUCTION RESULTS AND DISCUSSION As the field of analytics continues to evolve, methods guided by regulatory general…

ADVANCING ANALYTICAL PERFORMANCE FOR BIOTHERAPEUTICS WITH A BIO-INERT HPLC SYSTEM Pawel Bigos, Xiangsha Du, Duanduan Han, Robert Birdsall, Karen Nyholm Waters Corporation INTRODUCTION RESULTS AND DISCUSSION In biopharmaceutical analysis, undesired secondary analyte/ surface interactions have hindered performance in HPLC. Analytes…

Application Note Successful Method Migration of USP Insulin Assay to the Alliance™ iS Bio HPLC System Kimberly Martin, Lise Gauthier, Paula Hong Waters Corporation Abstract Within the pharmaceutical industry, compendial LC methods are used to assess whether the regulatory specifications…