Description

Brexpiprazole Impurity 7 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Brexpiprazole. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Brexpiprazole API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to confirm that Brexpiprazole meets stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to track the formation of degradation products in Brexpiprazole formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Provides necessary data for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA and EMA, supporting impurity identification and qualification.
• Research & Development: Aids in understanding the degradation pathways and chemical behavior of Brexpiprazole during synthesis and formulation processes.

Basic Information

Product Name	Brexpiprazole Impurity 7
CAS No.	1886188-97-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	7-(4-(4-(2,3-Dichlorophenyl)piperazin-1-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one; Brexpiprazole Related Compound 7; Brexpiprazole Impurity; Brexpiprazole Process Impurity; UNII-7K8I9C8V2W; Aripiprazole Impurity 7 (related structure); Antipsychotic Impurity
EINECS	Contact for details

Quality Control

Our Brexpiprazole Impurity 7 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 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.