General Information

Mirabegron Impurities and Mirabegron 

Daicel Pharma is a reliable source for synthesizing high-quality Mirabegron impurities, specifically (S)-Mirabegron, 2-(2-nitrophenyl)ethane amine, 2-(2,3-dinitrophenyl)ethan-1-amine hydrochloride, 2-(2,5-dinitrophenyl)ethan-1-amine hydrochloride, 2-(3-nitrophenyl)ethane amine, 2-(3,4-dinitrophenyl)ethan-1-amine, Cyanomethyl Mirabegron, ethyl 3-oxo-3-thioureidopropanoate, Mirabegron Dimer Impurity, Mirabegron impurity C, Mirabegron Impurity-R, N-Methyl Mirabegron Impurity, N-Nitroso Mirabegron, and N-Nitroso Mirabegron S-Isomer. These impurities help assess the quality, stability, and safety of the active pharmaceutical ingredient, Mirabegron. Daicel Pharma also offers custom synthesis of Mirabegron impurities, which can be shipped worldwide.

Mirabegron [CAS: 223673-61-8] is an oral medicine that treats an overactive bladder and is an agonist of the human beta-3 adrenergic receptor (ADRB3). It has muscle-relaxing, neuroprotective, and potential antineoplastic effects. Mirabegron is a beta-3 adrenergic agonist that treats overactive bladder syndrome.

Mirabegron

Mirabegron is a medication that treats overactive bladder (OAB), either alone or in combination with solifenacin. It treats neurogenic detrusor overactivity (NDO) in pediatric patients at least three years old and weighing at least 35 kg. Mirabegron is classified as a sympathomimetic medication and is available under the trade name Myrbetriq. The US FDA approved it in 2012 for treating overactive bladder with symptoms of urinary incontinence, urgency, and urinary frequency.

Mirabegron Structure and Mechanism of Action

The chemical name of Mirabegron is 2-Amino-N-[4-[2-[[(2R)-2-hydroxy-2-phenylethyl]amino]ethyl]phenyl]-4-thiazoleacetamide. Its chemical formula is C₂₁H₂₄N₄O₂S, and its molecular weight is approximately 396.5 g/mol.

Mirabegron relaxes the detrusor smooth muscle by activating beta-3 adrenergic receptor (AR) and increases bladder capacity.

Mirabegron Impurities and Synthesis

During the synthesis¹ of Mirabegron, impurities form, including the degradation products of Mirabegron, starting materials, and intermediates. These impurities can affect the drug’s quality, safety, and efficacy. Therefore, it is necessary to control and monitor the levels of these impurities during synthesis and after formation of the final product.

Daicel Pharma issues a Certificate of Analysis (CoA) for Mirabegron impurity standards, including (S)-Mirabegron, 2-(2-nitrophenyl)ethane amine, 2-(2,3-dinitrophenyl)ethan-1-amine hydrochloride, 2-(2,5-dinitrophenyl)ethan-1-amine hydrochloride, 2-(3-nitrophenyl)ethane amine, 2-(3,4-dinitrophenyl)ethan-1-amine, Cyanomethyl Mirabegron, ethyl 3-oxo-3-thioureidopropanoate, Mirabegron Dimer Impurity, Mirabegron impurity C, Mirabegron Impurity-R, N-Methyl Mirabegron Impurity, N-Nitroso Mirabegron, and N-Nitroso Mirabegron S-Isomer. The CoA is from an analytical facility that complies with current Good Manufacturing Practices (cGMP) and includes comprehensive characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity. We give additional characterization data such as 13C-DEPT and CHN on request. Daicel Pharma can prepare unknown Mirabegron impurities or degradation products. A complete characterization report accompanies each delivery.