Description

Mirabegron D5 is a deuterated isotopologue of the active pharmaceutical ingredient Mirabegron, specifically labeled with five deuterium atoms. This stable isotope-labeled compound is a critical reference standard and internal standard for the precise quantification and pharmacokinetic studies of Mirabegron in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is an essential tool for pharmaceutical R&D, clinical research, and bioanalytical laboratories focused on developing and validating robust assays for this β-3 adrenergic receptor agonist. The CAS number for this compound is 1215807-38-7.

Application

• Bioanalytical Reference Standard: Primary use as an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the accurate quantification of Mirabegron in plasma, serum, and urine.
• Pharmacokinetic & Metabolism Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Method Development & Validation: Critical for developing, optimizing, and validating regulatory-compliant analytical methods in pharmaceutical quality control and research laboratories.
• Deuterium-Labeled Tracer: Used in mechanistic studies to investigate metabolic pathways and stability of the parent drug molecule.
• Impurity Profiling: Aids in the identification and characterization of potential process-related impurities or degradants in Mirabegron API manufacturing.

Basic Information

Item	Detail
Product Name	Mirabegron D5
CAS No.	1215807-38-7
Molecular Formula	C21H19D5N4O5S
Molecular Weight	Approx. 429.52 g/mol
Synonyms	Mirabegron-d5; [D5]-Mirabegron; 2-(2-Amino-1,3-thiazol-4-yl)-N-[4-[2-[[(2R)-2-hydroxy-2-phenylethyl]amino]ethyl]phenyl]acetamide-d5; Betanis-d5; Myrbetriq-d5; YM178-d5; (R)-2-(2-Aminothiazol-4-yl)-N-(4-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)acetamide-d5
EINECS	Contact for details

Quality Control

Our Mirabegron D5 is manufactured under strict quality systems to ensure high chemical and isotopic purity, essential for its role as a reference material. Each batch undergoes comprehensive analysis, including HPLC for chemical purity, NMR and MS for structural and isotopic confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided, documenting the exact isotopic enrichment (D5), purity, and all analytical results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum confirms molecular ion and D5 labeling
Purity (HPLC)	≥ 98.0% (Chemical Purity)
Isotopic Enrichment	≥ 98 atom % D (D5)
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.