Description

Brexpiprazole Dihydrochloride CAS NO 913612-38-1 is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) of significant commercial importance. It is the dihydrochloride salt form of Brexpiprazole, a critical compound used in the synthesis of modern antipsychotic medications. This product is essential for pharmaceutical manufacturers and research institutions engaged in the development and production of central nervous system (CNS) therapeutics. We provide it with a focus on stringent quality control to ensure batch-to-batch consistency and supply chain reliability for global partners.

Application

• Pharmaceutical API Synthesis: Primary raw material for the commercial production of Brexpiprazole tablets and other dosage forms.
• Reference Standard: Serves as a certified reference material (CRM) for analytical method development, validation, and quality control testing in regulatory submissions.
• Clinical Research Material: Used in preclinical and clinical studies for investigating new formulations or therapeutic applications.
• Process Development: Key intermediate in scaling up and optimizing synthetic routes within R&D and pilot plant environments.
• Generic Drug Manufacturing: Critical for companies developing bioequivalent versions of branded Brexpiprazole medications post-patent expiry.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for toll synthesis and full-scale production.

Basic Information

Product Name	Brexpiprazole Dihydrochloride
CAS No.	913612-38-1
Molecular Formula	C₂₅H₂₇N₃O₂S·2HCl
Molecular Weight	506.49 g/mol
Synonyms	7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1,2,3,4-tetrahydroquinolin-2-one dihydrochloride; OPC-34712 dihydrochloride; Rexulti (API form); 4-(4-{4-[(7-Hydroxy-3,4-dihydro-2(1H)-quinolinyl)oxy]butyl}-1-piperazinyl)-1-benzothiophene dihydrochloride
EINECS	Contact for details

Quality Control

Our Brexpiprazole Dihydrochloride is manufactured under strict quality management systems. Each batch is tested to meet high-purity standards suitable for pharmaceutical applications, with specifications aligned with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, related substances, residual solvents, and other critical parameters. We support regulatory filings with consistent quality and full traceability.

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 in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.10%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤20 ppm
Residue on Ignition	≤0.1%

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