Description

Brexpiprazole Impurity 20 is a designated process-related impurity used in the pharmaceutical development and quality control of Brexpiprazole. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by serving as a reference standard for analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Brexpiprazole Impurity 20 in drug substance and drug product analysis.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor and control impurity profiles.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to ensure Brexpiprazole API meets specified impurity limits per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation and level of this impurity under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization and control data.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Brexpiprazole to minimize the formation of this specific impurity.

Basic Information

Product Name	Brexpiprazole Impurity 20
CAS No.	1420987-85-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1H)-one; Brexpiprazole Related Compound 20; Brexpiprazole EP Impurity H; Brexpiprazole Process Impurity; UNII-5V8L925P5I; 1,2,3,4-Tetrahydro-7-[4-[4-(4-benzothienyl)-1-piperazinyl]butoxy]-2-quinolinone
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, including advanced chromatographic techniques, to ensure high purity and compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA), detailing identity, purity, and impurity profile, is provided with each shipment and is 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 inert conditions if the primary container is opened repeatedly to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.