Description

Mirabegron Impurity 30 is a specified impurity and 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 purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and as a critical benchmark in stability studies for the production of Mirabegron-based therapeutics.

Application

• Primary use as a certified reference standard for the quantitative and qualitative analysis of Mirabegron API.
• Critical component in HPLC and GC method development and validation for impurity profiling.
• Essential for conducting stability studies and determining degradation pathways of Mirabegron formulations.
• Used in pharmaceutical quality control (QC) laboratories to monitor and control impurity levels during API synthesis.
• Serves as a research tool in analytical chemistry and pharmacokinetic studies related to Mirabegron.
• Supports regulatory filings (e.g., ANDA, NDA) by providing identifiable impurity data for health authorities.

Basic Information

Product Name	Mirabegron Impurity 30
CAS No.	83303-98-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mirabegron Related Compound 30; Mirabegron EP Impurity J; Mirabegron USP Impurity; Betmiga Impurity 30; Myrbetriq Impurity 30; (2R)-2-Hydroxy-2-(2-aminothiazol-4-yl)acetic acid (related to synthesis); 4-Thiazoleacetic acid, α-amino-2-oxo-, (αR)- (related structure)
EINECS	Contact for details

Quality Control

Every batch of Mirabegron Impurity 30 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques 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 each shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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%

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