Description

Brexpiprazole Impurity 79 is a designated process-related impurity or degradation product of the active pharmaceutical ingredient Brexpiprazole. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring during drug substance manufacturing. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require certified materials for method validation, stability studies, and regulatory compliance submissions to agencies like the FDA and EMA.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Brexpiprazole drug substance and finished products.
• Method Development and Validation: Used in developing and validating analytical methods, particularly HPLC and LC-MS, for impurity profiling.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control (QC) Testing: A critical component in the routine QC release testing of Brexpiprazole batches to ensure they meet stringent purity specifications.
• Regulatory Compliance: Supports the preparation of regulatory documentation (e.g., CMC sections) for new drug applications (NDA) and abbreviated new drug applications (ANDA).
• Research and Development: Used in R&D to study the degradation pathways and chemical behavior of Brexpiprazole, aiding in process optimization.

Basic Information

Product Name	Brexpiprazole Impurity 79
CAS No.	1191900-73-8
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 79; Brexpiprazole EP Impurity I; Brexpiprazole USP Related Compound; UNII-9V8I1B2T9F; 1,2,3,4-Tetrahydro-7-[4-[4-(4-thianaphthenyl)-1-piperazinyl]butoxy]-2-quinolinone
EINECS	Contact for details

Quality Control

Our Brexpiprazole Impurity 79 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests such as HPLC purity, NMR, and mass spectrometry for structural confirmation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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