Description

Brexpiprazole is a high-purity active pharmaceutical ingredient (API) and a key therapeutic agent in modern neuropsychiatric medicine. Its primary value lies in its unique mechanism of action as a serotonin-dopamine activity modulator, offering a differentiated clinical profile. This compound is essential for pharmaceutical manufacturers and research institutions engaged in the development and production of advanced antipsychotic medications.

Application

• Pharmaceutical API: Primary active ingredient in the commercial production of antipsychotic tablets.
• Neurological Research: Critical reference standard and investigational compound for studying schizophrenia and major depressive disorder (MDD) mechanisms.
• Formulation Development: Used in R&D for creating new dosage forms, including orally disintegrating tablets and long-acting injectables.
• Generic Drug Manufacturing: Serves as the core component for companies developing bioequivalent versions of branded brexpiprazole products.
• Clinical Trial Material (CTM): Supplied as GMP-grade material for Phase I-IV clinical studies.
• Analytical Testing: Employed as a primary standard in HPLC and LC-MS methods for quality control and pharmacokinetic studies.

Basic Information

Product Name	Brexpiprazole
CAS No.	913611-97-9
Molecular Formula	C₂₅H₂₇N₃O₂S
Molecular Weight	433.57 g/mol
Synonyms	7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}quinolin-2(1H)-one; OPC-34712; Rexulti (Trade Name); 7-[4-[4-(1-Benzothiophen-4-yl)-1-piperazinyl]butoxy]-1H-quinolin-2-one; 7-[4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy]-2(1H)-quinolinone
EINECS	Contact for details

Quality Control

Our Brexpiprazole is manufactured under strict quality management systems, targeting compliance with ICH Q7 guidelines and current Good Manufacturing Practices (cGMP). Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We ensure traceability and supply chain integrity from raw materials to finished API.

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 nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%

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