Description

Aripiprazole Impurity 53 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) aripiprazole by serving as a benchmark for impurity identification and quantification. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers focused on regulatory compliance and product quality assurance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Aripiprazole Impurity 53 in drug substances and finished products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Employed in routine QC testing of aripiprazole API and formulations to monitor impurity levels against ICH Q3A/B guidelines.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand impurity formation pathways.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Supports synthetic route optimization and process chemistry research to minimize the formation of this specific impurity.

Basic Information

Product Name	Aripiprazole Impurity 53
CAS No.	519138-48-8
Molecular Formula	C23H27Cl2N3O2
Molecular Weight	456.39 g/mol
Synonyms	7-{4-[4-(2,3-Dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1H)-one; Aripiprazole Related Compound 53; Aripiprazole EP Impurity G; Aripiprazole USP Related Compound G; UNII-7J3S35I65F; 1-(2,3-Dichlorophenyl)-4-[4-(2-oxo-1,2,3,4-tetrahydroquinolin-7-yl)oxy]butyl]piperazine
EINECS	Contact for details

Quality Control

Every batch of Aripiprazole Impurity 53 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing to ensure compliance with pharmacopeial standards (USP, EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analysis is provided with each shipment to guarantee traceability and reliability for your critical applications.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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