Cleanchem is a trusted provider of premium pharmaceutical reference materials, specializing in Pralsetinib and its associated compounds. Our catalog includes pharmacopeial and non-pharmacopeial Pralsetinib impurities, metabolites, nitrosamine derivatives (N-NO compounds), and stable isotope-labeled products. These reference standards play a critical role in pharmaceutical R&D, supporting activities such as product formulation, ANDA and DMF submissions, quality assurance, analytical method development, and stability assessments.
All Pralsetinib-related substances undergo comprehensive characterization and are delivered with complete Certificates of Analysis and supporting analytical documentation to ensure regulatory adherence. Upon request, we can offer EP/USP traceable standards. Our products are routinely re-evaluated to maintain consistent quality and performance.
Chemical Name: (1s,4R)-N-((S)-1-(6-(4-fluoro-1H-pyrazol-1-yl)pyridin-3-yl)ethyl)-1-methoxy-4-(4-(methyl-13C)-6-((5-methyl-1H-pyrazol-3-yl)(nitroso)amino)pyrimidin-2-yl-2,5-13C2-1,3-15N2)-N-nitrosocyclohexane-1-carboxamide