Description

Mirabegron Impurity CAS NO 1581285-26-8 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Mirabegron. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential tool for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Mirabegron API batches.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing to monitor impurity levels and ensure API purity meets pharmacopeial standards (e.g., USP, EP, ICH).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data on impurity identity and characterization for regulatory filings with agencies like the FDA and EMA.
• Research & Development: Supports synthetic route optimization and process chemistry research by identifying process-related impurities.

Basic Information

Product Name	Mirabegron Impurity
CAS No.	1581285-26-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mirabegron Related Compound; Mirabegron Impurity Standard; Mirabegron Process Impurity; Betmiga Impurity; Myrbetriq Impurity; (2R)-2-Hydroxy-2-(2-aminothiazol-4-yl)acetic acid impurity (related to Mirabegron synthesis); 4-(2-Amino-1,3-thiazol-4-yl)-2-hydroxybutanoic acid derivative
EINECS	Contact for details

Quality Control

Every batch of Mirabegron Impurity CAS NO 1581285-26-8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including HPLC purity, is provided with each shipment.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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 impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.