Description

Brexpiprazole Impurity 53 is a designated impurity of the active pharmaceutical ingredient Brexpiprazole, a key compound in the development and quality control of antipsychotic medications. This high-purity reference standard is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily used by R&D scientists and QC/QA professionals in the pharmaceutical industry for method development, validation, and routine batch analysis.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Brexpiprazole drug substance and finished products.
• Method Development & Validation: Essential for developing and validating sensitive and specific analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance: Used in routine batch release testing to monitor and control the levels of this specific impurity, ensuring compliance with ICH guidelines.
• Stability Studies: Employed to identify and quantify degradation products formed under various stress conditions during drug product stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Aids in understanding the degradation pathways and chemical behavior of Brexpiprazole during synthesis and formulation processes.

Basic Information

Product Name	Brexpiprazole Impurity 53
CAS No.	2368233-78-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Brexpiprazole Related Compound 53; 7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1H-quinolin-2-one Impurity 53; UNII-8V4V5LJ66Q (component); Brexpiprazole EP Impurity B; Brexpiprazole USP Impurity; API Brexpiprazole Impurity 53
EINECS	Contact for details

Quality Control

Every batch of Brexpiprazole Impurity 53 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH Q3A/B guidelines for impurities. Comprehensive characterization is performed using advanced techniques (HPLC, LC-MS, NMR). Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a 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. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total Impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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