Description

Mirabegron Impurity 8 Hcl is a high-purity chemical 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 quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Mirabegron API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurities.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and CMC sections.
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Mirabegron formulations.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and impurity profile of Mirabegron.

Basic Information

Product Name	Mirabegron Impurity 8 Hcl
CAS No.	1684452-81-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Mirabegron Related Compound 8 Hydrochloride; Mirabegron Impurity 8 Hydrochloride Salt; Mirabegron EP Impurity H HCl; Mirabegron USP Impurity 8 HCl; 2-(2-Aminothiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide Impurity 8 Hydrochloride; Betmiga Impurity 8 HCl; Myrbetriq Impurity 8 Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Mirabegron Impurity 8 Hcl is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and compliance with in-house specifications and relevant pharmacopeial guidelines. A comprehensive Certificate of Analysis (COA) detailing all test results 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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 95.0%
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.