Description

[2H8]-n-Desmethylcariprazine CAS NO 1308278-85-4 is a high-purity, deuterium-labeled internal standard critical for accurate quantitative analysis in bioanalytical and pharmacokinetic studies. This stable isotope-labeled compound is essential for ensuring precision and reliability in mass spectrometry-based assays, particularly those employing LC-MS/MS techniques. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers involved in drug metabolism and development.

Application

• Internal Standard for LC-MS/MS Analysis: Serves as a critical reference compound for the precise quantification of n-Desmethylcariprazine and related metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic (PK) and Bioequivalence Studies: Enables accurate measurement of drug concentration-time profiles, supporting ADME (Absorption, Distribution, Metabolism, and Excretion) research and regulatory submissions.
• Drug Metabolism Research: Used in metabolite identification and profiling studies to understand the biotransformation pathways of Cariprazine and its analogs.
• Clinical Trial Support: Provides the analytical foundation for monitoring drug levels in patients during clinical phases, ensuring data integrity and compliance with GLP standards.
• Forensic and Toxicology Analysis: Facilitates the sensitive and specific detection of antipsychotic agents and their metabolites in forensic investigations.
• Method Development and Validation: A key reagent for developing, optimizing, and validating robust analytical methods in compliance with ICH and FDA guidelines.

Basic Information

Product Name	[2H8]-n-Desmethylcariprazine
CAS No.	1308278-85-4
Molecular Formula	C21H26D8ClN3O
Molecular Weight	~ 379.99 g/mol
Synonyms	Deuterated n-Desmethylcariprazine; n-Desmethylcariprazine-d8; Cariprazine Metabolite-d8; 3-((4-(2,4-Dichlorophenyl)piperazin-1-yl)methyl)-1-(1,1,1,3,3,3-hexadeuterio-2-hydroxy-2-methylpropyl)-4-((1,1,2,2-tetradeuteriophenyl)methyl)diazepan-2-one; RGH-188 Metabolite-d8; Vraylar Metabolite-d8; Deuterium Labeled Desmethyl Cariprazine
EINECS	Contact for details

Quality Control

Every batch of [2H8]-n-Desmethylcariprazine is manufactured under strict quality systems and undergoes comprehensive analytical characterization to ensure identity, purity, and isotopic enrichment. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes data from NMR (1H, 13C), mass spectrometry, and HPLC purity analysis. Our quality commitment aligns with the standards expected for high-value reference materials used in GLP/GMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. For short-term use, the product may be stored at 2-8°C. Allow the vial to equilibrate to room temperature before opening to minimize moisture uptake. The material should be handled in a controlled environment to preserve its integrity as a quantitative analytical standard.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 atom % D
Chemical Purity	≥ 95%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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