Description

Mirabegron o-Glucuronide is a major, pharmacologically relevant metabolite of the β-3 adrenergic receptor agonist mirabegron. This compound is essential for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics (DMPK), and bioanalytical method development. It serves as a critical reference standard for scientists and quality control laboratories in the pharmaceutical and biotechnology industries requiring precise analytical validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for quantitative and qualitative analysis in drug development.
• Metabolite Identification & Profiling: Crucial for in vitro and in vivo DMPK studies to understand the metabolic fate of mirabegron.
• Bioanalytical Method Development: Used to develop and validate sensitive LC-MS/MS or HPLC-UV methods for quantifying mirabegron and its metabolites in biological matrices.
• Pharmacology & Toxicology Studies: Enables research into the activity, safety, and potential drug-drug interactions of mirabegron metabolites.
• Quality Control & Assurance: Serves as an impurity standard in the quality control of mirabegron active pharmaceutical ingredient (API) and finished drug products to ensure batch consistency and regulatory compliance.

Basic Information

Product Name	Mirabegron o-Glucuronide
CAS No.	1365244-65-0
Molecular Formula	C29H39N5O9S
Molecular Weight	633.71 g/mol
Synonyms	Mirabegron Glucuronide; Mirabegron O-Glucuronide; Mirabegron Metabolite M1; (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; Myrbetriq Metabolite; YM-538 Metabolite
EINECS	Contact for details

Quality Control

Our Mirabegron o-Glucuronide is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (NMR, MS), 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 every shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator 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.