Description

Brexpiprazole Impurity CAS NO 2138169-93-2 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Brexpiprazole. It serves as a vital tool for analytical method development, validation, and impurity profiling. Pharmaceutical manufacturers, analytical laboratories, and research institutions require this impurity standard to meet stringent pharmacopeial guidelines and regulatory requirements.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for identifying and quantifying related substances in Brexpiprazole API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and LC-MS methods to ensure specificity, accuracy, and precision.
• Quality Control & Assurance (QC/QA): Acts as a system suitability standard in routine quality control testing to monitor batch-to-batch consistency and purity.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Brexpiprazole formulations.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to develop purification processes for the API.

Basic Information

Item	Detail
Product Name	Brexpiprazole Impurity
CAS No.	2138169-93-2
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; Brexpiprazole Process Impurity; Brexpiprazole Degradant; Atypical Antipsychotic Impurity; OPC-34712 Impurity
EINECS	Contact for details

Quality Control

Every batch of Brexpiprazole Impurity CAS NO 2138169-93-2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for identity, purity, and strength. Certificates of Analysis (COA) detailing batch-specific results are available upon request to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool, and well-ventilated area. Keep the container tightly sealed to protect from moisture.

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)	Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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