Analytical Method Development Strategy for Controlling Two New Nitrosamine Drug Substance Related Impurities (NDSRIs) in a Pharmaceutical Drug Product for Treatment of a Rare Disease

• DOI: 10.1007/s10337-025-04405-8
• Publication Date: 2025-03-24T17:43:13Z
• Authors: Partha Mukherjee; Xin Yao; Nastry Brignol; Madison Chao; Steven Tuske; M. Osman Sheikh; Jon Brudvig; Sheela Sitaraman; Jill M. Weimer; Saroj Ramdas