Description

Aripiprazole Impurity 4 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 analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Aripiprazole API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels against ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), ANDAs, and other regulatory filings to agencies like the FDA and EMA.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP, JP) for Aripiprazole.

Basic Information

Item	Details
Product Name	Aripiprazole Impurity 4
CAS No.	1424857-63-5
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; Aripiprazole Process Impurity; Aripiprazole Degradant; ABILIFY Impurity 4
EINECS	Contact for details

Quality Control

Our Aripiprazole Impurity 4 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR, MS), and residual solvent analysis to ensure it meets the stringent requirements for a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single impurity ≤ 1.0%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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