Description

Aripiprazole Metabolite CAS NO 58899-27-7 is a key intermediate and reference standard in the development and quality control of the antipsychotic drug aripiprazole. This compound is critical for pharmaceutical research and manufacturing, enabling precise metabolic profiling and ensuring drug safety and efficacy. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in active pharmaceutical ingredient (API) synthesis, impurity characterization, and bioanalytical studies.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of aripiprazole metabolites in drug substance and finished product analysis.
• Metabolic Pathway Research: Essential for in-vitro and in-vivo studies to understand the biotransformation and pharmacokinetics of aripiprazole.
• Impurity Profiling and Control: Serves as a critical marker for monitoring and controlling process-related impurities and degradation products during API manufacturing.
• Bioanalytical Method Development: Employed in the validation of LC-MS/MS and HPLC methods for accurate detection of metabolites in biological matrices.
• Regulatory Submission Support: Provides necessary data for drug master files (DMF), investigational new drug (IND), and new drug application (NDA) submissions to agencies like the FDA and EMA.
• Clinical Trial Material Characterization: Used to ensure the consistency and quality of drug batches used in clinical studies.
• Academic and Preclinical Research: Supports fundamental pharmacological and toxicological research on aripiprazole's mechanism of action.

Basic Information

Product Name	Aripiprazole Metabolite
CAS No.	58899-27-7
Molecular Formula	C23H27Cl2N3O2
Molecular Weight	448.39 g/mol
Synonyms	Dehydroaripiprazole; 7-{4-[4-(2,3-Dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1H)-one; OPC-14857; OPC-14857 metabolite; Aripiprazole Dehydro Metabolite; Aripiprazole Impurity; DM-1451
EINECS	Contact for details

Quality Control

Our Aripiprazole Metabolite is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identity confirmation via spectroscopic methods (IR, MS, NMR). We provide full traceability and Certificates of Analysis (COA) that detail all test results against stringent in-house specifications. Our quality commitment supports compliance with cGMP and ICH Q7 guidelines for pharmaceutical intermediates.

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 conditions.

Specification

Item	Specification
Appearance	White to off-white powder
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 single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 1.0%
Heavy Metals	≤ 20 ppm

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