N-Nitroso Acebutolol

N-Nitroso-Acebutolol is a genotoxic and potentially carcinogenic nitrosamine impurity associated with Acebutolol, a cardioselective beta-1 adrenergic receptor blocker commonly used to treat hypertension and cardiac arrhythmias. The chemical structure of this impurity is described as N-(3-acetyl-4-(2-hydroxy-3-(isopropyl(nitroso)amino)propoxy)phenyl)butyramide, which forms via nitrosation of the secondary amine group in Acebutolol under conditions that favor nitrosation, such as acidic environments, oxidative stress, or the presence of nitrites during API synthesis, formulation, or degradation. Cas.no: 3038740-99-4 ; Molecular formula: C₁₈H₂₇N₃O₅; Molecular weight: 365.42 g/mol. This impurity is non-volatile and highly potent, and according to the USFDA Carcinogenic Potency Categorization Approach (CPCA), it is classified as Potency Category 4, with acceptable intake limit of 1500 ng/day, consistent with USFDA, EMA, and ICH M7 (R1) guidelines for genotoxic impurities.

Manasa Life Sciences manufactures nitrosamine impurities in Hyderabad, India, and supplies products to markets across Asia, Europe, Africa, the GCC, and the UAE, ensuring reliable delivery, full traceability, and Good Documentation Practices (GDP) for nitrosamine impurities. And also we support complete nitrosamine-control readiness by supplying certified nitrosamine impurity reference standards, conducting in-depth risk assessments, and developing and validating ultra-sensitive LC-MS/MS and GC-MS analytical methods. Our solutions enable accurate detection, quantification, and control of nitrosamine impurities whether theoretical, synthesis-related, or degradation-derived helping manufacturers meet USP-relevant expectations, maintain strict global regulatory compliance, and safeguard patient safety.