2-Bromo-5-nitroso-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine

N-Nitroso Edoxaban Impurity 4 is a genotoxic and potentially carcinogenic nitrosamine impurity that may form in Edoxaban, an oral direct factor Xa inhibitor used for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE). Edoxaban is commercially available as oral tablet dosage forms for chronic administration. Chemically, this impurity is described as 2-bromo-5-nitroso-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine, indicating nitrosation within the nitrogen-containing heterocyclic thiazolopyridine moiety used as a key structural element or intermediate in Edoxaban synthesis. Formation of this impurity can occur during API synthesis, processing, or degradation, particularly under acidic, oxidative, or nitrite-contaminated conditions that promote nitrosation of heterocyclic amines. CAS.No: NA; Molecular formula: C6H6BrN3OS; Molecular weight: 248.1.

At Manasa Life Sciences, we support pharmaceutical manufacturers in the effective management of N-Nitroso Edoxaban Impurity 4 by performing comprehensive nitrosamine risk assessments, identifying nitrosation-prone synthetic intermediates and process steps, and evaluating potential contributions from raw materials, reagents, solvents, and excipients. We develop and validate high-sensitivity analytical methods, including LC-MS/MS and GC-MS, for accurate trace-level detection and quantification. Our integrated approach strengthens nitrosamine-control strategies, ensures GMP compliance, and safeguards product quality and patient safety throughout drug development and commercial manufacturing.