Description

Aripiprazole Impurity 27 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities in the manufacturing of the active pharmaceutical ingredient (API) Aripiprazole. It is primarily used by analytical chemists, quality control (QC) laboratories, and regulatory affairs professionals within the pharmaceutical and contract research organization (CRO) sectors to ensure drug safety, efficacy, and compliance with stringent global regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the calibration of analytical instruments (HPLC, LC-MS) in impurity profiling.
• Method Development and Validation: Used to develop, optimize, and validate chromatographic methods for the specific detection of Aripiprazole Impurity 27.
• Quality Control and Batch Release: Critical for routine QC testing of Aripiprazole API batches to monitor and control impurity levels against ICH Q3A/B thresholds.
• 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.
• Stability Studies: Employed in forced degradation and long-term stability studies of Aripiprazole to identify and track impurity formation over time.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Item	Details
Product Name	Aripiprazole Impurity 27
CAS No.	2220149-92-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aripiprazole Related Compound 27; Aripiprazole EP Impurity I; Aripiprazole USP Impurity; 7-{4-[4-(2,3-Dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1H)-one Impurity; Abilify Impurity 27; OPC-14597 Impurity 27
EINECS	Contact for details

Quality Control

Every batch of Aripiprazole Impurity 27 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

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

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