Description

Brexpiprazole-D8 is a deuterated analog of the atypical antipsychotic Brexpiprazole, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity, isotopically labeled compound is essential for ensuring accuracy and reliability in pharmacokinetic and bioanalytical studies. It is primarily utilized by pharmaceutical researchers, contract research organizations (CROs), and analytical laboratories involved in drug development and quality control.

Application

• Primary use as an Internal Standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the quantification of Brexpiprazole in biological matrices.
• Critical component in Pharmacokinetic (PK) and Bioequivalence Studies to ensure precise measurement of drug concentration over time.
• Essential for Drug Metabolism and Excretion (DMPK) Research, aiding in the understanding of the parent drug's fate in the body.
• Used in the development and validation of robust Bioanalytical Methods according to FDA, EMA, and ICH guidelines.
• Supports Therapeutic Drug Monitoring (TDM) assay development for personalized medicine approaches in psychiatric care.
• Valuable reference material in Pharmaceutical Quality Control laboratories for impurity profiling and stability studies.

Basic Information

Product Name	Brexpiprazole-D8
CAS No.	1427049-19-1
Molecular Formula	C25H19D8N3O2
Molecular Weight	~ 413.55 g/mol
Synonyms	7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1H-quinolin-2-one-d8; OPC-34712-D8; RX-7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1H-quinolin-2-one-d8; Deuterated Brexpiprazole; Brexpiprazole (deuterated); Brexpiprazole-d8 Internal Standard
EINECS	Contact for details

Quality Control

Our Brexpiprazole-D8 is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment required for analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing parameters such as chemical purity (by HPLC), isotopic purity (by MS), and residual solvent content. We adhere to relevant industry guidelines for reference standards to support your compliance with GLP and GMP requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material 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 structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (by MS)	≥ 98.0 atom % D
Chemical Purity (by NMR)	Conforms
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 1.0%

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