Description

Brexpiprazole Impurity 76 is a designated impurity standard 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 marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs professionals involved in the synthesis, validation, and compliance of Brexpiprazole-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Brexpiprazole Impurity 76 in drug substance and drug product analysis.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurities during stability studies.
• Quality Control (QC) Testing: Employed in routine QC release testing of Brexpiprazole API to ensure compliance with stringent pharmacopeial (e.g., USP, ICH) impurity limits.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization and control data.
• Process Chemistry Research: Aids in the investigation and optimization of synthetic pathways to minimize the formation of this specific impurity.
• Stability Studies: Acts as a benchmark to track impurity profiles in Brexpiprazole formulations under various stress conditions (heat, light, humidity).

Basic Information

Product Name	Brexpiprazole Impurity 76
CAS No.	433303-94-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1,2,3,4-tetrahydroquinolin-2-one; Brexpiprazole Related Compound 76; Brexpiprazole Impurity F; UNII-7V2A2U4K4P; Aripiprazole Impurity 76 (historical context); OPC-34712 Impurity 76
EINECS	Contact for details

Quality Control

Every batch of Brexpiprazole Impurity 76 is manufactured and controlled under a strict quality management system. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA), detailing purity, identity, 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 in a desiccated environment to maintain stability and purity. Handle and store under inert atmosphere if specified.

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)	Single unspecified 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.