Waters, 186008927, mAb Subunit Standard

Waters mAb Subunit Standard can be used in the benchmarking of LC and LC-MS techniques, proficiency testing among different instruments and laboratories, and system suitability. This standard is a filtered and stabilized formulation of reduced, IdeS-digested NIST Reference Material 8671 (NIST mAb), a humanized IgG1κ expressed from a murine cell line. Each vial of the standard is provided in an approximately 25 μg quantity.

Waters mAb Subunit Standard is a stabilized, filtered monoclonal antibody preparation used to assess liquid chromatography and LC–mass spectrometry performance during subunit-level biopharmaceutical analysis. The material is derived from NIST Reference Material 8671, a humanized IgG1κ monoclonal antibody, after IdeS digestion and reduction. The resulting Fc/2, Fd′, and light-chain subunits provide a reproducible sample for checking separation patterns and mass assignments of antibody fragments. Each vial contains approximately 25 µg in a solid formulation and is stored at −20°C. The standard supports system suitability, analytical method benchmarking, and comparability across instruments or laboratories. It is not an intact monoclonal antibody mass standard and should not be used interchangeably with reference materials intended for intact-protein analysis.