Description

Brexpiprazole Impurity 20 is a designated process-related impurity used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Brexpiprazole. This compound is critical for ensuring the purity, safety, and regulatory compliance of the final drug product by serving as a reference standard in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development, production, and quality assurance of Brexpiprazole.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Brexpiprazole API.
• Critical component in analytical method development and validation (HPLC, UPLC) for Brexpiprazole.
• Essential for regulatory compliance and filing, supporting ICH guidelines on impurity profiling.
• Used in stability studies to monitor impurity levels in Brexpiprazole formulations over time.
• Supports in-house quality control (QC) and quality assurance (QA) testing protocols.
• Valuable for research and development into the synthesis and degradation pathways of Brexpiprazole.

Basic Information

Product Name	Brexpiprazole Impurity 20
CAS No.	105685-34-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1H-quinolin-2-one; Brexpiprazole Related Compound; Brexpiprazole Process Impurity; OPC-34712 Impurity; 7-[4-[4-(1-Benzothiophen-4-yl)-1-piperazinyl]butoxy]-2(1H)-quinolinone; Rexulti Impurity
EINECS	Contact for details

Quality Control

Every batch of Brexpiprazole Impurity 20 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced techniques including HPLC, NMR, and MS. Certificates of Analysis (COA) with detailed chromatographic purity data are available upon request.

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 under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 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.