Description

Aripiprazole Impurity 35 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Aripiprazole. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The reliable identification and quantification of this impurity are essential for maintaining stringent pharmacopeial standards.

Application

• Primary use as a certified reference standard for the analysis of Aripiprazole API and finished drug products.
• Critical component in pharmaceutical research and development for impurity profiling and characterization studies.
• Essential for method validation and verification of analytical procedures (e.g., HPLC, UPLC, LC-MS) in QC laboratories.
• Used in stability studies to monitor impurity levels in drug substances and products over time.
• Serves as a regulatory compliance tool to meet ICH, USP, and EP guidelines for impurity identification and reporting.
• Supports pharmacopeial testing and the development of monographs for Aripiprazole.

Basic Information

Product Name	Aripiprazole Impurity 35
CAS No.	2250242-22-7
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; Aripiprazole Related Compound 35; Aripiprazole Impurity K; UNII-9QZ2K9I8V4; 2(1H)-Quinolinone, 3,4-dihydro-7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-
EINECS	Contact for details

Quality Control

Every batch of Aripiprazole Impurity 35 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with specified standards. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial requirements.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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