Description

Mirabegron Impurity 26 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Mirabegron. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Mirabegron API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to ensure accurate detection and measurement of impurities.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in routine quality control testing to monitor batch-to-batch consistency and purity of the API.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity identity and levels for drug master files (DMFs).
• Stability Studies: Employed to track the formation and behavior of this impurity under various stress conditions during drug stability testing.
• Research & Development (R&D): Used in pharmaceutical R&D to study the degradation pathways and chemical behavior of Mirabegron.

Basic Information

Product Name	Mirabegron Impurity 26
CAS No.	91828-74-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mirabegron Related Compound 26; Mirabegron EP Impurity 26; Mirabegron USP Impurity 26; (2R)-2-[(4-{[(4-Ethylphenyl)carbamoyl]amino}phenyl)methyl]-N-(2-hydroxy-2-methylpropyl)-2-phenylacetamide Impurity; Betmiga Impurity 26; Myrbetriq Impurity 26; Mirabegron Degradation Product; Mirabegron Process Impurity
EINECS	Contact for details

Quality Control

Our Mirabegron Impurity 26 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and compliance with pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every 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). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and the container kept tightly sealed after each use to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
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.