Description

Aripiprazole N4-Oxide is a key pharmaceutical intermediate and impurity standard in the synthesis and quality control of the antipsychotic drug Aripiprazole. This compound is critical for ensuring the purity, safety, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical manufacturers engaged in process development, method validation, and impurity profiling.

Application

• As a reference standard for the identification and quantification of the N-oxide impurity in Aripiprazole API and finished drug products.
• In pharmaceutical research and development for studying the degradation pathways and stability profile of Aripiprazole.
• For analytical method development and validation (e.g., HPLC, LC-MS) in quality control laboratories.
• As a critical starting material or intermediate in advanced synthetic routes for Aripiprazole and its analogues.
• In regulatory compliance and documentation, providing essential data for drug master files (DMFs) and regulatory submissions (e.g., FDA, EMA).
• For calibration and system suitability testing of analytical equipment used in pharmaceutical analysis.

Basic Information

Product Name	Aripiprazole N4-Oxide
CAS No.	573691-11-9
Molecular Formula	C23H27N3O3
Molecular Weight	393.48 g/mol
Synonyms	7-{4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy}-3,4-dihydro-2(1H)-quinolinone N4-Oxide; Aripiprazole N-Oxide; Aripiprazole Impurity N-Oxide; OPC-14597 N-Oxide; Abilify N-Oxide Impurity; Aripiprazole Related Compound N-Oxide
EINECS	Contact for details

Quality Control

Our Aripiprazole N4-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and control of related substances, to ensure it meets the stringent requirements for pharmaceutical reference standards and intermediates. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting compliance with in-house specifications.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.