Description

Aripiprazole Related Compound B is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker and analytical standard for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Aripiprazole. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in method development, validation, and quality control. Precise characterization of such related substances is fundamental to meeting stringent global pharmacopeial requirements.

Application

• Pharmaceutical Impurity Profiling and Identification as a certified reference material for Aripiprazole.
• Analytical Method Development and Validation (HPLC, UPLC, GC) for stability-indicating assays.
• Quality Control and Batch Release Testing in API and finished drug product manufacturing.
• Pharmacopeial Compliance for testing per USP, EP, ICH, and other regulatory guidelines.
• Stability Studies to monitor degradation pathways and establish shelf-life.
• Regulatory Submissions to support New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).

Basic Information

Product Name	Aripiprazole Related Compound B
CAS No.	1424858-02-5
Molecular Formula	C23H27Cl2N3O2
Molecular Weight	464.39 g/mol
Synonyms	7-(4-(4-(2,3-Dichlorophenyl)piperazin-1-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one; Aripiprazole Impurity B; Aripiprazole Related Substance B; UNII-3R6P5PZ2UQ; OPC-14597 Impurity B; Abilify Impurity B; 2(1H)-Quinolinone, 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-
EINECS	Contact for details

Quality Control

Our Aripiprazole Related Compound B is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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