Description

Aripiprazole Impurity CAS NO 131732-09-7 is a high-purity 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 impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during the manufacturing and stability testing of Aripiprazole API.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to ensure accurate detection and quantification limits.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to verify that Aripiprazole drug substance and drug products meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Regulatory Submissions and Compliance: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough understanding and control of the impurity profile.
• Stability Studies: Used to track the formation and level of this impurity over time under various storage conditions, supporting shelf-life determination.
• Research and Development: Facilitates studies on the formation pathway, toxicity, and chemical behavior of this impurity during synthetic process optimization.

Basic Information

Product Name	Aripiprazole Impurity
CAS No.	131732-09-7
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; Aripiprazole Process Impurity; UNII-5R6J5RGF85; 2(1H)-Quinolinone, 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-; Aripiprazole Impurity F (EP); Aripiprazole Deshydroxy Impurity
EINECS	Contact for details

Quality Control

Our Aripiprazole Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data, ensuring traceability and compliance with ICH Q3A/B, USP, and EP guidelines. Our quality commitment supports your regulatory and research needs with reliable, consistent reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.