Description

Mirabegron Impurity CAS NO 1624261-01-3 is a high-purity reference standard used in the pharmaceutical development and quality control of Mirabegron, a medication for overactive bladder. This specific impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of this specific impurity in Mirabegron active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels throughout the manufacturing process.
• Stability Studies & Forced Degradation: Employed to understand the degradation pathways of Mirabegron and to establish appropriate shelf-life specifications.
• Quality Control & Batch Release: A critical component in the QC laboratory for routine testing of production batches against established impurity limits as per ICH guidelines.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities, as required by ICH Q3A(R2) and Q3B(R2).
• Research & Development: Used in synthetic chemistry R&D to study the formation and fate of this impurity during the API synthesis and purification process.

Basic Information

Product Name	Mirabegron Impurity
CAS No.	1624261-01-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mirabegron Related Compound; Mirabegron Process Impurity; Mirabegron Degradant; 2-(2-Amino-1,3-thiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide impurity; Betmiga Impurity; Myrbetriq Impurity; (R)-2-(2-Aminothiazol-4-yl)-N-(4-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)acetamide impurity
EINECS	Contact for details

Quality Control

Every batch of Mirabegron Impurity CAS 1624261-01-3 is manufactured and controlled under strict quality management systems. Comprehensive analytical testing, including HPLC purity, related substances, and structural confirmation (NMR, MS), is performed to ensure the material meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) with batch-specific data, traceable to primary standards, is provided with each shipment to support your regulatory and quality 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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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