Description

Aripiprazole-Impurity 17 is a designated impurity standard used in the pharmaceutical development and quality control of the antipsychotic drug Aripiprazole. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by accurately identifying and quantifying related substances. It is an essential tool for analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Aripiprazole and its related products.
• Method Development and Validation: Critical for developing and validating analytical methods (e.g., HPLC, UPLC) to monitor impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Quality Control and Assurance (QC/QA): Used in routine batch testing to ensure Aripiprazole API and drug products meet stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over product quality.
• Research and Development: Supports synthetic route optimization and process chemistry studies by identifying and characterizing process-related impurities.

Basic Information

Product Name	Aripiprazole-Impurity 17
CAS No.	1424857-89-5
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 17; Aripiprazole Impurity C; UNII-9QZ8D6I8QN; Aripiprazole EP Impurity C; 1-(2,3-Dichlorophenyl)-4-[4-(2-oxo-1,2,3,4-tetrahydroquinolin-7-yl)oxy]butyl]piperazine
EINECS	Contact for details

Quality Control

Our Aripiprazole-Impurity 17 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and structural confirmation (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
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.