Description

Aripiprazole N1-Oxide is a key pharmaceutical intermediate and metabolite of the antipsychotic drug Aripiprazole. Its primary value lies in enabling advanced research into drug metabolism, pharmacokinetics, and the development of analytical reference standards. This compound is essential for pharmaceutical R&D laboratories, quality control departments, and manufacturers involved in the production and validation of Aripiprazole-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the N1-Oxide metabolite in bioanalytical studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Critical for studying the metabolic pathways, stability, and clearance of Aripiprazole in preclinical and clinical research.
• Impurity Profiling and Control: Serves as a known impurity standard to monitor and control the quality of Aripiprazole Active Pharmaceutical Ingredient (API) and finished drug products according to ICH guidelines.
• Analytical Method Development: Employed in the development and validation of HPLC, LC-MS, and other chromatographic methods for accurate metabolite detection.
• Process Chemistry Research: Used in studies to understand and optimize synthetic routes, including oxidation steps, for Aripiprazole manufacturing.

Basic Information

Product Name	Aripiprazole N1-Oxide
CAS No.	573691-09-5
Molecular Formula	C23H27Cl2N3O3
Molecular Weight	480.39 g/mol
Synonyms	7-{4-[4-(2,3-Dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1H)-one 1-Oxide; Aripiprazole N-Oxide; Aripiprazole Impurity N1-Oxide; OPC-14597 N1-Oxide; Aripiprazole Metabolite; Abilify N-Oxide Metabolite; 1-Oxidoaripiprazole
EINECS	Contact for details

Quality Control

Our Aripiprazole N1-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical research and reference standard applications. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming specifications for identity, purity, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled accordingly to maintain stability.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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