Description

Aripiprazole Impurity 3 is a high-purity reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Aripiprazole. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is essential for professionals engaged in method development, stability studies, and the synthesis of Aripiprazole.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Aripiprazole API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and GC methods for impurity detection and separation.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive identification and characterization data for specified impurities.
• Research & Development: Serves as a key intermediate or marker in synthetic route optimization and process chemistry research for Aripiprazole.
• Pharmacopoeial Testing: Used in testing to meet the specifications outlined in pharmacopoeias such as USP, EP, or BP for Aripiprazole.

Basic Information

Item	Details
Product Name	Aripiprazole Impurity 3
CAS No.	1359829-23-4
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 Related Compound C; Aripiprazole Deshydroxy Impurity; UNII-9J97361D2P; Aripiprazole Impurity C; 2(1H)-Quinolinone, 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-; Aripiprazole Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Aripiprazole Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including HPLC purity analysis, identity confirmation (IR, NMR), and residual solvent screening, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment.

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 dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
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 individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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