Description

Aripiprazole Impurity 2 CAS NO 1424857-93-1 is a high-purity chemical reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Aripiprazole. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in the development, validation, and routine testing of Aripiprazole-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Aripiprazole API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Aripiprazole meets stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Aripiprazole.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the formation and mitigation of this specific impurity during the API manufacturing process.

Basic Information

Item	Details
Product Name	Aripiprazole Impurity 2
CAS No.	1424857-93-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aripiprazole Related Compound 2; Aripiprazole Impurity B; 7-{4-[4-(2,3-Dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1H)-one; Dehydro Aripiprazole; Aripiprazole Degradant; OPC-14597 Impurity
EINECS	Contact for details

Quality Control

Our Aripiprazole Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (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 confirming compliance with relevant specifications.

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 absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.