Description

Mirabegron Impurity CAS NO 1796931-48-0 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Mirabegron, a medication for overactive bladder. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control of related substances during manufacturing. It is an essential material for analytical laboratories, regulatory affairs, and quality assurance departments within pharmaceutical companies and contract research organizations (CROs).

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material for the identification and structural elucidation of related substances in Mirabegron active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to quantify specified impurities against established acceptance criteria, ensuring every batch complies with ICH Q3A/B guidelines.
• Regulatory Submission and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to define impurity limits and justify the control strategy for the drug substance.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish shelf-life and storage recommendations.
• Process Chemistry Research: Aids chemists in understanding the formation pathway of this impurity during synthesis, enabling process optimization to minimize its generation.

Basic Information

Product Name	Mirabegron Impurity
CAS No.	1796931-48-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	2-(2-Amino-1,3-thiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide; Mirabegron Related Compound; Mirabegron Process Impurity; Betmiga Impurity; Myrbetriq Impurity; (R)-2-(2-Aminothiazol-4-yl)-N-(4-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)acetamide
EINECS	Contact for details

Quality Control

Every batch of Mirabegron Impurity CAS 1796931-48-0 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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