N-Nitroso S-Mirabegron

N-Nitroso S-Mirabegron is a nitrosamine impurity of Mirabegron, a β₃-adrenergic receptor agonist. Its chemical name is (S)-2-(2-aminothiazol-4-yl)-N-(4-(2-((2-hydroxy-2-phenylethyl)(nitroso)amino)ethyl)phenyl)acetamide. It has a molecular formula of C21H23N5O3S and a molecular weight of 425.5g/mol. The registered CAS number 3035190-56-5. As a nitrosamine impurity, N-Nitroso S-Mirabegron is subject to global nitrosamine-control bases. Regulatory guidance lists nitrosamines related to Mirabegron under Potency Category 3, with a recommended acceptable intake limit of 400 ng/day.

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.