Description

Mirabegron Impurity CAS NO 1154949-80-0 is a high-purity 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 and quantification of related substances. It is an essential material for analytical laboratories, regulatory affairs, and R&D departments within the pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Mirabegron active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Essential for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS/MS, to monitor impurity profiles.
• Stability Studies: Employed in forced degradation and long-term stability studies of Mirabegron to understand degradation pathways and establish shelf-life.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Quality Control (QC) Testing: Serves as a system suitability standard and for routine batch release testing in QC laboratories to ensure impurity levels are within ICH guidelines.
• Process Chemistry Research: Used by chemists to study and optimize the Mirabegron synthesis route, helping to minimize the formation of this specific impurity.

Basic Information

Product Name	Mirabegron Impurity
CAS No.	1154949-80-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mirabegron Related Compound; Mirabegron Impurity Standard; Mirabegron Process Impurity; 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

Our Mirabegron Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the principles of current Good Manufacturing Practice (cGMP) and ICH guidelines Q3A(R2) and Q3B(R2) on impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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