Mirabegron Related Compounds & Impurities

Mirabegron is a selective beta-3 adrenergic receptor agonist that relaxes detrusor smooth muscle, used for overactive bladder.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Mirabegron reference standards, pharmacopeial and non-pharmacopeial Mirabegron impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Mirabegron-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Mirabegron
Mirabegron Impurity A(Hydrochloride Salt)
Mirabegron Impurity 32
Mirabegron Impurity A
N-(4-(2-Iminoethyl)phenyl)-2-(thiazol-4-yl)acetamide
Ethyl-2,2-Dichloro Acetoacetate
Mirabegron M5
Mirabegron Impurity 5
Racemic Mirabegron-D5
Mirabegron Impurity 10
Glipizide Nitroso Impurity 1
Mirabegron Impurity 2 Hydrochloride
Mirabegron Impurity 8
Mirabegron Impurity 4
Ortho-Mirabegron
Mirabegron Impurity 11
Mirabegron Impurity 12
Mirabegron EP Impurity A
Mirabegron Impurity B
Mirabegron Impurity G
Mirabegron Impurity 9
Mirabegron Related Compound B Dihydrochloride
Mirabegron Impurity F
Mirabegron Impurity B Hydrochloride Salt
Mirabegron Impurity 6
Dehydroxy Mirabegron Hydrochloride Salt
Mirabegron Impurity 38
Mirabegron Impurity 13
Mirabegron Impurity 31
Mirabegron EP Impurity G
(R)-2-Hydroxy-N-[2-(4-aminophenyl)ethyl]-2-phenylethanamide
2-(4-Nitrophenyl)Ethanamine Hydrochloride
2-(3,4-dinitrophenyl)ethylamine
2-(3,5-dinitrophenyl) Ethanamine Hydrochloride
2-(2,4-dinitrophenyl)ethanamine
Mirabegron Impurity 66
Mirabegron Impurity 65
Mirabegron Form Beta
Mirabegron Impurity 66
(R)-2-((4-Aminophenethyl)amino)-1-phenylethanol Hydrochloride
Mirabegron EP Impurity C
Mirabegron Impurity 64
Mirabegron Impurity 34
Mirabegron Impurity G Dihydrochloride
Mirabegron Impurity 33
Mirabegron Impurity 43
Mirabegron Deshydroxy Impurity
Mirabegron Impurity 27
(R)-N-(2-hydroxy-2-phenylethyl)-N-(4-nitrophenethyl)nitrous amide hydrochloride
(R)-N-(4-aminophenethyl)-N-(2-hydroxy-2-phenylethyl)nitrous amide hydrochloride
(R)-2-(2-aminothiazol-4-yl)-N-(4-(2-((2-hydroxy-2-phenylethyl)(methyl)amino)ethyl)phenyl)acetamide
Mirabegron Impurity 39
(R)-N-(4-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)-2-(2-(methyleneamino)thiazol-4-yl)acetamide
Mirabegron EP Impurity D
Mirabegron Impurity 47
Mirabegron Impurity 48
N-Nitroso Mirabegron
Mirabegron M11 Lithium Salt
Mirabegron M12
Mirabegron N-Glucuronide
N-Nitroso Mirabegron EP Impurity B
Mirabegron Nitroso Impurity 2
(R)-1-((2-methyl-4-nitrophenethyl)amino)-1-phenylethanol
(1R)-2-2-(4-aminophenyl)ethyl-methylamino-1-phneylethan-1-ol
(E)-N-(4-nitrophenethyl)-2-phenylethenamine
(R)-2-(ethyl(4-nitrophenethyl)amino)-1-phenylethanol
Mirabegrone DP1 Impurity
Mirabegron Impurity 57
Mirabegron Impurity 59
Mirabegron Impurity 58
MIRABEGRON ALPHA FORM
Glipizide Nitroso Impurity 2
N-Nitroso Mirabegron Stage-1 Impurity
Mirabegron EP Impurity B
2-(4-aminothiazol-2-yl)-N-(4-(2-(phenethylamino)ethyl)phenyl)acetamide
(S)-N-(4-(2-(2-aminothiazol-4-yl)acetamido)phenethyl)-2-hydroxy-2-phenylacetamide
(R)-N-(4-(2-(2-(2-(2-aminothiazol-5-yl)acetamido)thiazol-4-yl)acetamido)phenethyl)-2-hydroxy-2-phenylacetamide
(R)-2-(2-aminothiazol-4-yl)-N-(4-(2-((2-hydroxy-2-phenylethyl)(nitroso)amino)ethyl)phenyl)-N-nitrosoacetamide
N-Nitroso-2-hydroxyethyl benzylamine
rac-N-Nitroso Mirabegron
Mirabegron Nitroso Impurity 3
Mirabegron Impurity 28
Mirabegron Impurity 29
Mirabegron Racemic
N-Nitroso S-Mirabegron Impurity
[(R)-2-((4-(isopropylamino)phenethyl)-amino)-1-phenylethan-1-ol]
Mirabegron Impurity 62
Mirabegron Impurity 61
3-Nitrophenyl ethylamine
N-(4-(2-((2-Hydroxy-2-phenylethyl)amino)ethyl)phenyl)-2-(2-(methyleneamino)thiazol-4-yl)acetamide
(R)-2-(2-aminothiazol-4-yl)-N-(4-(2-(2-aminothiazol-4-yl)acetamido) phenyl)-N-(2-hydroxy-2-phenylethyl)acetamide
Mirabegron Impurity D Hydrochloride Salt
Mirabegron Impurity D
Mirabegron Impurity 17
Mirabegron Nitroso Impurity 5
Mirabegron M5 Hydrochloride
Di(2-Amino-4-thiazolyl)acetyl Mirabegron
Mirabegron Impurity 71
Mirabegron Impurity 74
Mirabegron Impurity 77
Mirabegron Impurity 76
Mirabegron Impurity 79
Mirabegron Impurity 53
Mirabegron Impurity 81
Mirabegron Impurity 82
Mirabegron Impurity 93
Mirabegron Impurity 91
Mirabegron Impurity 80
Mirabegron Impurity 92
Mirabegron Impurity 73
Mirabegron Impurity 94
Mirabegron Impurity 95
Mirabegron Nitroso Impurity 11
Mirabegron Nitroso Impurity 12
Ethyl Mirabegron Thiourea Impurity
Mirabegron Impurity 31 Hydrochloride
N-Nitroso Mirabegron EP Impurity C
Mirabegron Impurity 14
Mirabegron Impurity 15
Mirabegron Impurity 18
Mirabegron Impurity 19
Mirabegron Impurity
Mirabegron Impurity 20
Mirabegron Dimer
Mirabegron Impurity 1
N-Nitroso Mirabegron EP Impurity D
Mirabegron O-Glucuronide

Metabolites

Mirabegron M15 (YM-9636324)
Mirabegron M13 (YM-538859)
Mirabegron M8

Isotope Labelled Compounds

Mirabegron D8
rac-Mirabegron Nitroso D5