Description

Brexpiprazole Impurity CAS NO 2116542-21-1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical development and quality control, specifically in the analysis of the active pharmaceutical ingredient Brexpiprazole. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure product purity, meet regulatory requirements, and support method validation.

Application

• Pharmaceutical Impurity Profiling and Identification in Brexpiprazole API and finished drug products.
• Analytical Method Development and Validation (HPLC, UPLC, LC-MS) for quality control laboratories.
• Reference Standard for quantitative and qualitative analysis in compliance with ICH guidelines.
• Research and Development of Brexpiprazole, including stability studies and degradation pathway elucidation.
• Regulatory Submission Support, providing necessary data for drug master files (DMFs) and regulatory filings.
• Calibration Standard for ensuring the accuracy and precision of analytical instrumentation.

Basic Information

Product Name	Brexpiprazole Impurity
CAS No.	2116542-21-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Brexpiprazole Related Compound; Brexpiprazole Process Impurity; Brexpiprazole Degradant; 7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1,2,3,4-tetrahydroquinolin-2-one Impurity; UNII-9F8S6L8B2R; Brexpiprazole Specified Impurity; API Impurity of Brexpiprazole
EINECS	Contact for details

Quality Control

Our Brexpiprazole Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data (HPLC/UPLC) upon request, supporting compliance with ICH Q3A, Q3B, and current Good Manufacturing Practice (cGMP) standards for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product 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
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.