Description

Aripiprazole Dimer CAS NO 1797986-18-5 is a high-purity pharmaceutical intermediate, specifically a dimeric impurity of the antipsychotic drug Aripiprazole. This compound is critical for ensuring the quality, safety, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers and analytical laboratories for research, development, and stringent quality control processes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the dimeric impurity in Aripiprazole API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Process Chemistry Research: Employed in studying and optimizing the synthesis pathway of Aripiprazole to minimize the formation of this specific dimer.
• Quality Assurance/Quality Control (QA/QC): A critical component in batch release testing to ensure API purity meets pharmacopeial standards (e.g., USP, EP).
• Regulatory Submissions: Provides necessary data on impurity structure and levels for regulatory filings with agencies like the FDA and EMA.
• Stability Studies: Used to track the formation of degradation products under various stress conditions.

Basic Information

Product Name	Aripiprazole Dimer
CAS No.	1797986-18-5
Molecular Formula	C₄₆H₅₂Cl₂N₆O₂
Molecular Weight	791.86 g/mol
Synonyms	7-{4-[4-(2,3-Dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1H)-one dimer; Aripiprazole Dimeric Impurity; Aripiprazole Impurity Dimer; Bis(7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1H)-one); UNII-9F8S6L8B2F (component); Aripiprazole related compound Dimer
EINECS	Contact for details

Quality Control

Our Aripiprazole Dimer is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical analysis. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles as determined by advanced analytical techniques including HPLC, NMR, and MS. We support compliance with ICH Q3A/B guidelines and pharmacopeial requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
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.