Description

Aripiprazole-Impurity 13 is a designated impurity reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Aripiprazole. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Aripiprazole API and its formulations.
• Method Development and Validation (HPLC/LC-MS): Essential for developing, validating, and verifying chromatographic methods to detect and quantify this specific impurity.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Aripiprazole batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Used to monitor the formation and level of this impurity over time under various storage conditions to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports impurity profiling and characterization studies during the synthesis and process optimization of Aripiprazole.

Basic Information

Product Name	Aripiprazole-Impurity 13
CAS No.	2116542-22-2
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 Impurity; Aripiprazole Process Impurity; Abilify Impurity; OPC-14597 Impurity
EINECS	Contact for details

Quality Control

Our Aripiprazole-Impurity 13 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectroscopic data to support your regulatory and quality requirements. The material is suitable for use as a pharmaceutical reference standard.

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. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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