Description

Aripiprazole Impurity 47 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of specific impurities during the development and manufacturing of the active pharmaceutical ingredient (API) Aripiprazole. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and production, ensuring drug safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development and validation.
• Impurity Profiling: Identification and quantification of this specific impurity in Aripiprazole API and finished drug products using HPLC, UPLC, or LC-MS.
• Quality Control & Assurance: Routine testing in GMP environments to ensure Aripiprazole batches meet stringent purity specifications set by pharmacopeias (USP, EP, ICH).
• Stability Studies: Monitoring the formation of this impurity under various stress conditions to establish drug shelf-life and storage requirements.
• Regulatory Submissions: Providing essential data and characterization for regulatory filings (e.g., FDA, EMA) to support drug approval.
• Research & Development: Used in studies to understand the degradation pathways and synthesis by-products of Aripiprazole.

Basic Information

Product Name	Aripiprazole Impurity 47
CAS No.	2250242-47-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aripiprazole Related Compound 47; Aripiprazole EP Impurity I; Aripiprazole USP Impurity; 7-{4-[4-(2,3-Dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1H)-one Impurity; UNII-Contact for details; Aripiprazole Degradation Product; Aripiprazole Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Aripiprazole Impurity 47 is manufactured and controlled under a strict quality management system. Comprehensive analytical testing, including HPLC purity, related substances, and identity confirmation (IR, MS, NMR), is performed to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) containing batch-specific data, traceable to primary standards, is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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