Description

Brexpiprazole Sulfoxide Impurity is a key process-related impurity and degradation product of the atypical antipsychotic drug Brexpiprazole. This compound is of critical importance for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is essential for laboratories in the pharmaceutical and biotechnology sectors focused on ensuring the purity, safety, and regulatory compliance of Brexpiprazole API and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a high-purity certified reference material (CRM) for qualitative and quantitative analysis.
• Analytical Method Development & Validation (HPLC/LC-MS): Crucial for developing and validating stability-indicating methods to monitor Brexpiprazole and its impurities.
• Quality Control & Assurance (QC/QA): Used for system suitability testing, peak identification, and impurity profiling in API and drug product batch release.
• Stability Studies: Employed to identify and quantify degradation products formed under various stress conditions (e.g., oxidative stress).
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing impurity characterization data.
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Brexpiprazole Sulfoxide Impurity
CAS No.	1191900-51-2
Molecular Formula	C25H27N3O3S
Molecular Weight	449.57 g/mol
Synonyms	7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1,2,3,4-tetrahydroquinolin-2-one Sulfoxide; Brexpiprazole Related Compound Sulfoxide; Brexpiprazole Sulfoxide; OPC-34712 Sulfoxide; RU-58668 Sulfoxide; 1,2,3,4-Tetrahydro-7-[4-[4-(4-thianaphthenyl)-1-piperazinyl]butoxy]-2(1H)-quinolinone S-Oxide
EINECS	Contact for details

Quality Control

Every batch of Brexpiprazole Sulfoxide Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant or inert atmosphere to ensure stability.

Specification

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

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