N-Nitroso Atenolol

N-Nitroso Atenolol is a genotoxic and potentially carcinogenic nitrosamine impurity that may form in Atenolol, a cardioselective β₁-adrenergic blocker widely used in the management of hypertension, angina pectoris, and acute myocardial infarction. Atenolol is commonly available in oral tablet dosage forms, and injectable formulations are also used in acute care settings. Chemically, this impurity is described as 2-(4-(2-hydroxy-3-(isopropyl(nitroso)amino)propoxy)phenyl)acetamide, indicating nitrosation of the secondary isopropylamine moiety present in the Atenolol structure. Formation of N-Nitroso Atenolol can occur during API synthesis, formulation processing, or degradation, particularly in the presence of nitrite impurities, acidic environments, or oxidative conditions that promote nitrosation reactions. CAS No:134720-04-0; Molecular Formula: C14H21N3O4; Molecular Weight: 295.34g/mol.

As a structurally complex, N-Nitroso Atenolol is classified under the US FDA Carcinogenic Potency Categorization Approach (CPCA) as Potency Category 4, with a default acceptable intake limit of 1500 ng/day, in accordance with US FDA, EMA, and ICH M7 (R1) guidelines. Given the chronic use of Atenolol in cardiovascular therapy, stringent control of this genotoxic impurity is considered a critical regulatory requirement.

At Manasa Life Sciences, we support pharmaceutical manufacturers in the effective management of N-Nitroso Atenolol by conducting comprehensive nitrosamine risk assessments, identifying nitrosation-prone synthetic, formulation, and degradation pathways, and evaluating potential contributions from raw materials and excipients. We develop and validate high-sensitivity analytical methods, including LC-MS/MS and HRMS, for reliable 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.