Description

Brexpiprazole Impurity 49 is a designated impurity standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient Brexpiprazole. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification, quantification, and control of this specific impurity. It is an essential tool for analytical laboratories, quality assurance departments, and research scientists working in pharmaceutical manufacturing and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Brexpiprazole Impurity 49 in drug substance and drug product analysis.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Brexpiprazole.
• Quality Control and Batch Release: Used in routine QC testing to monitor impurity profiles and ensure batches of Brexpiprazole API meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish shelf-life and storage recommendations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate understanding and control of the impurity profile.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Brexpiprazole Impurity 49
CAS No.	1700655-67-9
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 49; Brexpiprazole EP Impurity I; Brexpiprazole USP Impurity; Aripiprazole Derivative; OPC-34712 Impurity
EINECS	Contact for details

Quality Control

Every batch of Brexpiprazole Impurity 49 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (MS, NMR) techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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. Keep the container in a dry, cool, and well-ventilated place.

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

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