Description

Aripiprazole Impurity 19 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antipsychotic drug Aripiprazole. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and manufacturers of active pharmaceutical ingredients (APIs) who require reliable reference standards for method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Aripiprazole Impurity 19 in drug substances and finished products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Aripiprazole.
• Quality Control & Batch Release: Used in routine QA/QC testing to monitor impurity levels and ensure batches meet International Council for Harmonisation (ICH) guidelines and pharmacopeial specifications (USP, EP).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides essential data for impurity identification and qualification reports required for regulatory filings with agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during Aripiprazole synthesis, helping to optimize manufacturing processes for higher purity.

Basic Information

Product Name	Aripiprazole Impurity 19
CAS No.	203395-78-2
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 19; Aripiprazole Deshydroxy Impurity; Aripiprazole Process Impurity; OPC-14597 Impurity; Abilify Impurity 19; 3,4-Dihydro-7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-2(1H)-quinolinone
EINECS	Contact for details

Quality Control

Every batch of Aripiprazole Impurity 19 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. The material 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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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