Description

Brexpiprazole Impurity 2 CAS NO 2094559-58-5 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 Brexpiprazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control processes.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Brexpiprazole API.
• Essential for method development and validation in analytical chemistry, particularly for HPLC and LC-MS techniques.
• Critical component in stability studies to monitor impurity profiles and ensure drug product shelf-life.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Supports research and development of Brexpiprazole, including process chemistry optimization.
• Acts as a calibration standard in quality control laboratories for routine batch release testing.

Basic Information

Product Name	Brexpiprazole Impurity 2
CAS No.	2094559-58-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Brexpiprazole Related Compound 2; 7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1,2,3,4-tetrahydroquinolin-2-one; UNII-9Q8X6Z4U4C; 1,2,3,4-Tetrahydro-7-[4-[4-(4-thianaphthenyl)-1-piperazinyl]butoxy]-2-quinolinone; Brexpiprazole Impurity
EINECS	Contact for details

Quality Control

Our Brexpiprazole Impurity 2 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. 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 controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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