Description

Mirabegron-003 CAS NO 1018983-85-1 is a high-purity pharmaceutical intermediate and reference standard, specifically a key derivative in the synthesis pathway of Mirabegron. This compound is of critical importance for research and development, enabling the precise study of metabolic pathways and the production of high-quality active pharmaceutical ingredients (APIs). It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in urology and overactive bladder (OAB) therapeutic development.

Application

• Pharmaceutical Intermediate: A crucial building block in the multi-step synthesis of the active pharmaceutical ingredient (API) Mirabegron.
• Reference Standard: Used in analytical laboratories for method development, validation, and quality control (QC) testing of Mirabegron APIs and finished dosage forms.
• Metabolite Research: Serves as a precursor or analog for studying the pharmacokinetics and metabolic profile of Mirabegron-related compounds.
• Process Chemistry & Scale-Up: Employed in research to optimize synthetic routes and develop cost-effective, scalable manufacturing processes.
• Impurity Profiling: Utilized to identify, quantify, and control potential genotoxic or process-related impurities in Mirabegron production.
• Regulatory Submissions: Provides essential chemical entity data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Mirabegron-003
CAS No.	1018983-85-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mirabegron Impurity 3; Mirabegron Related Compound 3; Mirabegron Intermediate 003; 2-(2-Amino-1,3-thiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide derivative; Betmiga Impurity 3; Myrbetriq Intermediate; β3-Adrenoceptor Agonist Intermediate
EINECS	Contact for details

Quality Control

Our Mirabegron-003 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing all specified parameters. Our quality commitment aligns with ICH guidelines to support our clients' regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or in a desiccator to prevent degradation. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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