Description

Aripiprazole-002 is a high-purity pharmaceutical intermediate and reference standard, identified by CAS NO 2250243-33-3. It is a critical compound in the research, development, and quality control of active pharmaceutical ingredients (APIs) for neuropsychiatric therapeutics. This material is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on central nervous system (CNS) drug development and generic API synthesis.

Application

• Pharmaceutical Intermediate: A key building block in the synthesis of Aripiprazole and its related analogs.
• Reference Standard: Used for analytical method development, validation, and quality control (QC) testing in pharmaceutical manufacturing.
• Impurity Standard: Employed as a certified reference material (CRM) for identifying and quantifying process-related impurities and degradation products.
• Research & Development: Serves as a starting material or precursor in medicinal chemistry for developing new CNS-targeting drug candidates.
• Regulatory Submissions: Provides essential data and characterization for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Generic Drug Manufacturing: Critical for ensuring bioequivalence and meeting stringent regulatory requirements for generic versions of antipsychotic medications.

Basic Information

Product Name	Aripiprazole-002
CAS No.	2250243-33-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	7-(4-(4-(2,3-Dichlorophenyl)piperazin-1-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one derivative; Aripiprazole Impurity; Aripiprazole Related Compound; Aripiprazole Intermediate; OPC-14597 derivative; Abilify Intermediate; Antipsychotic Intermediate; CNS Drug Intermediate
EINECS	Contact for details

Quality Control

Our Aripiprazole-002 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. We provide full traceability and detailed Certificates of Analysis (COA) that comply with current Good Manufacturing Practice (cGMP) principles and ICH guidelines, supporting your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

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 impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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