Description

Brexpiprazole Impurity 77 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Brexpiprazole. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for method development, validation, and stability studies within the pharmaceutical development lifecycle.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Brexpiprazole drug substance and drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing in GMP environments to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research & Development: Supports synthetic route optimization and process chemistry research by helping to identify and control impurity formation.

Basic Information

Product Name	Brexpiprazole Impurity 77
CAS No.	1783311-11-4
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 77; Brexpiprazole EP Impurity G; Brexpiprazole USP Impurity; UNII-9I0Q3J6A7I; 1,2,3,4-Tetrahydro-7-[4-[4-(4-thianaphthenyl)-1-piperazinyl]butoxy]-2-quinolinone
EINECS	Contact for details

Quality Control

Every batch of Brexpiprazole Impurity 77 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available for audit and regulatory review.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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