Description

Mirabegron Impurity CAS NO 1684452-83-2 is a high-purity chemical 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, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for analytical laboratories, quality assurance departments, and research scientists working in pharmaceutical manufacturing and regulatory affairs.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify and quantify this specific impurity in Mirabegron active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control and Release Testing: Employed in routine QC testing to ensure Mirabegron batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Used to monitor the formation of this impurity over time under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding and control of the drug substance impurity profile.
• Research and Development: Facilitates studies on the formation pathway, toxicity, and control strategies for this impurity during the synthetic process of Mirabegron.

Basic Information

Product Name	Mirabegron Impurity
CAS No.	1684452-83-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mirabegron Related Compound, Mirabegron Process Impurity, Mirabegron Degradant, Mirabegron Specified Impurity, 2-(2-Aminothiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide Impurity, YM178 Impurity, Betmiga Impurity
EINECS	Contact for details

Quality Control

Our Mirabegron Impurity CAS 1684452-83-2 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, 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 for identity, purity, and impurities. Our quality commitment aligns with the principles of GMP and relevant ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider conditions recommended for labile pharmaceutical compounds.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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