Description

Brexpiprazole-D8 is a deuterated analog of the atypical antipsychotic Brexpiprazole, specifically labeled with eight deuterium atoms. This stable isotope-labeled compound is an essential reference standard and internal standard for precise analytical quantification in complex matrices. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in bioanalytical method development, pharmacokinetic studies, and drug metabolism research.

Application

• Internal Standard for LC-MS/MS: Used as a critical internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the accurate quantification of Brexpiprazole in biological samples (e.g., plasma, serum, urine).
• Bioanalytical Method Development & Validation: Serves as a reference material for developing and validating robust, sensitive, and specific analytical methods in compliance with GLP and FDA/EMA guidelines.
• Pharmacokinetic (PK) and Toxicokinetic (TK) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Drug Metabolism and Metabolite Identification: Aids in the identification and characterization of drug metabolites using mass spectrometry, leveraging its isotopic signature.
• Quality Control & Impurity Profiling: Acts as a certified reference material for quality control testing of active pharmaceutical ingredients (APIs) and finished drug products.
• Forensic and Clinical Toxicology: Employed in specialized testing for therapeutic drug monitoring (TDM) or forensic investigations requiring high analytical certainty.

Basic Information

Product Name	Brexpiprazole-D8
CAS No.	1427049-21-5
Molecular Formula	C25H19D8N3O2
Molecular Weight	~409.55 g/mol
Synonyms	7-{4-[4-(1-Benzothiophen-4-yl)piperazin-1-yl]butoxy}-1H-quinolin-2-one-D8; OPC-34712-D8; 7-[4-[4-(1-Benzothiophen-4-yl)-1-piperazinyl]butoxy]-2(1H)-quinolinone-D8; Deuterated Brexpiprazole; Brexpiprazole (deuterated); Rexulti-D8 (deuterated analog)
EINECS	Contact for details

Quality Control

Our Brexpiprazole-D8 is manufactured under strict quality systems to ensure the highest standards of isotopic purity and chemical integrity. Each batch undergoes rigorous analytical testing, including NMR and High-Resolution Mass Spectrometry (HRMS) for structural and isotopic confirmation, and HPLC/UPLC for chemical purity assessment. Comprehensive Certificates of Analysis (COA) detailing isotopic enrichment (typically ≥98% D), chemical purity (typically ≥95%), and analytical data are provided to support your regulatory and research 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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Isotopic Purity (D-enrichment)	≥98% (by MS)
Chemical Purity (HPLC)	≥95%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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