Description

Mirabegron 2-Oxo Impurity is a key process-related impurity and degradation product of the active pharmaceutical ingredient Mirabegron. This compound is critical for pharmaceutical research, development, and quality control, serving as a certified reference standard for analytical method validation and impurity profiling. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in the production and testing of Mirabegron to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of the 2-oxo impurity in Mirabegron API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, validating, and verifying chromatographic methods to monitor impurities during stability studies and release testing.
• Quality Control & Assurance (QC/QA): Employed in routine batch analysis to ensure the impurity profile of Mirabegron meets ICH Q3A(R2) and pharmacopeial (USP, EP) guidelines.
• Stability Studies: Used to track the formation of this degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation studies.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding the degradation pathways and synthetic by-products of Mirabegron, helping to optimize manufacturing processes for higher purity.

Basic Information

Product Name	Mirabegron 2-Oxo Impurity
CAS No.	1684453-05-1
Molecular Formula	C21H24N4O2S
Molecular Weight	396.51 g/mol
Synonyms	2-Oxo Mirabegron; Mirabegron Oxo Impurity; Mirabegron Related Compound; (2R)-2-[(2-Amino-1,3-thiazol-4-yl)methyl]-N-[4-[2-[[(2R)-2-hydroxy-2-phenylethyl]amino]ethyl]phenyl]acetamide 2-Oxo Derivative; Betmiga 2-Oxo Impurity; Myrbetriq 2-Oxo Impurity; 1684453-05-1; Mirabegron Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Mirabegron 2-Oxo Impurity is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our products are characterized using advanced techniques including HPLC, LC-MS, NMR, and IR spectroscopy. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications developed in line with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%

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