Description

Mirabegron Impurity 11 CAS NO 1684452-85-4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Mirabegron during its development and manufacturing. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and quality control testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Mirabegron API batches.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions as part of drug stability testing.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Research & Development: Used in R&D settings to study the metabolic pathways, degradation mechanisms, and synthesis pathways of Mirabegron.
• Quality Assurance/Quality Control (QA/QC): Acts as a benchmark in routine QC testing to ensure API purity meets pharmacopeial standards (e.g., USP, EP).

Basic Information

Product Name	Mirabegron Impurity 11
CAS No.	1684452-85-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mirabegron Related Compound 11; Mirabegron EP Impurity J; Mirabegron USP Impurity; 2-(2-Amino-1,3-thiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide impurity; Betmiga Impurity 11; Myrbetriq Impurity 11; (2R)-2-({2-[4-({2-[(2-Amino-1,3-thiazol-4-yl)acetyl]amino}phenyl)ethyl]amino}-2-phenylethanol Related Substance
EINECS	Contact for details

Quality Control

Our Mirabegron Impurity 11 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, identity confirmation (by IR/LC-MS), and residual solvent screening, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific 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). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.