Description

Brexpiprazole Impurity 45 is a designated impurity standard used in the analytical profiling 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. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Brexpiprazole Impurity 45 in drug substance and drug product.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure Brexpiprazole API and formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B impurity limits.
• Stability Studies: Employed as a marker to monitor the formation of this specific impurity during forced degradation and long-term stability studies of Brexpiprazole.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in R&D to understand the degradation pathways and synthesis by-products of Brexpiprazole.

Basic Information

Product Name	Brexpiprazole Impurity 45
CAS No.	63430-35-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1H-quinolin-2-one; Brexpiprazole Related Compound 45; Brexpiprazole EP Impurity G; Brexpiprazole USP Impurity 45; Brexpiprazole Process Impurity; Aripiprazole Derivative; OPC-34712 Impurity
EINECS	Contact for details

Quality Control

Our Brexpiprazole Impurity 45 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized and qualified using advanced techniques including HPLC, GC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH, USP, and EP guidelines.

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 compound is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.