Description

Cariprazine D8 is a deuterated isotopologue of the antipsychotic drug Cariprazine, where eight hydrogen atoms are replaced with deuterium. This compound is a critical internal standard used in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical R&D and quality control laboratories engaged in the development and analysis of neuropsychiatric therapeutics.

Application

• Internal Standard for LC-MS/MS: Primary application as a stable, non-interfering internal standard for the precise quantification of Cariprazine and its metabolites in biological matrices like plasma and serum.
• Pharmacokinetic (PK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical trials.
• Metabolite Profiling & Identification: Aids in the structural elucidation and quantification of Cariprazine metabolites using mass spectrometry.
• Bioanalytical Method Development & Validation: Serves as a critical reference material for developing, optimizing, and validating robust analytical methods compliant with FDA and ICH guidelines.
• Drug Impurity & Degradation Studies: Used as a reference marker in stability-indicating methods to monitor drug purity and identify degradation products.
• Forensic & Clinical Toxicology: Supports accurate measurement of drug levels in forensic analysis and therapeutic drug monitoring (TDM).

Basic Information

Product Name	Cariprazine D8
CAS No.	1308278-50-3
Molecular Formula	C26H28D8Cl2N4O
Molecular Weight	~483.5 g/mol
Synonyms	Cariprazine-d8; (3aR,4S,7R,7aS)-2-((1R,2R)-2-((4-(2,3-Dichlorophenyl)piperazin-1-yl)methyl)cyclohexyl)hexahydro-4,7-methano-1H-isoindole-1,3(2H)-dione-d8; Deuterated Cariprazine; RGH-188 D8; Vraylar D8 (trade name analog); UNII-6F0B7F8G1C (deuterated form); Internal Standard for Cariprazine
EINECS	Contact for details

Quality Control

Our Cariprazine D8 is manufactured under strict quality systems to ensure the highest isotopic purity and chemical integrity required for analytical standards. Each batch is characterized using advanced techniques including NMR (for deuterium incorporation), HPLC, and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, isotopic enrichment, and analytical results, supporting compliance with ICH Q2(R1) guidelines for method validation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

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 (Deuterium Enrichment)	≥98 atom % D
Water Content (KF)	≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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