Description

Mirabegron n-Glucuronide is a major, pharmacologically relevant metabolite of the β-3 adrenergic receptor agonist mirabegron. This compound is critical for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics (PK), and bioanalytical method validation. It is an essential reference standard for laboratories in the pharmaceutical and contract research organization (CRO) sectors requiring high-purity materials for accurate analytical testing and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for quantitative and qualitative analysis in drug development.
• Metabolite Identification & Profiling: Used in in vitro and in vivo studies to identify and quantify metabolic pathways of mirabegron.
• Bioanalytical Method Development: Serves as a critical standard for developing and validating LC-MS/MS, HPLC, and other chromatographic assays in biological matrices.
• Pharmacokinetic (PK) and Toxicokinetic (TK) Studies: Essential for determining the concentration-time profile of the metabolite to understand drug exposure and safety.
• Doping Control Analysis: Potential application as a reference compound in sports anti-doping laboratories for detecting mirabegron misuse.
• Impurity Characterization: Used to identify and control glucuronide-related impurities in mirabegron active pharmaceutical ingredient (API) batches.

Basic Information

Product Name	Mirabegron n-Glucuronide
CAS No.	1365244-68-3
Molecular Formula	C29H39N5O8S
Molecular Weight	617.71 g/mol
Synonyms	Mirabegron N-Glucuronide; Mirabegron Glucuronide; (2R,3S,4S,5R,6S)-3,4,5-Trihydroxy-6-[2-[[(2R)-2-hydroxy-2-[4-[2-[[(2S)-2-(2-thienyl)-2-hydroxyethyl]amino]ethyl]phenyl]ethyl]amino]ethoxy]oxane-2-carboxylic acid; Betmiga Metabolite; YM-538 Metabolite; Mirabegron Major Metabolite; β-3 Adrenoceptor Agonist Metabolite
EINECS	Contact for details

Quality Control

Every batch of Mirabegron n-Glucuronide is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with each shipment to guarantee traceability, consistency, and reliability for your critical research applications.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, moisture-free environment. For long-term storage under inert atmosphere, seal under argon or nitrogen. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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