Description

Cariprazine is a high-purity, small molecule pharmaceutical active ingredient (API) with the CAS registry number 839712-12-8. It is a critical intermediate or reference standard in the research, development, and quality control of novel antipsychotic medications. This compound is essential for pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in the production and validation of central nervous system (CNS) therapeutics.

Application

• Pharmaceutical API Synthesis: Primary use as the active pharmaceutical ingredient in the commercial manufacturing of antipsychotic drugs.
• Reference Standard for QC/QA: Serves as a high-purity standard for analytical method development, validation, and routine quality control testing in pharmaceutical labs.
• Clinical Research & Development: Used in preclinical and clinical studies to investigate pharmacokinetics, pharmacodynamics, and formulation development.
• Process Chemistry & Scale-Up: Employed as a key intermediate in process optimization and scale-up activities for efficient commercial production.
• Regulatory Submissions: Provides the necessary certified material for stability studies and documentation required for regulatory filings (e.g., FDA, EMA).
• Academic & Biomedical Research: Utilized in university and institutional research to study receptor pharmacology and mechanisms of action related to dopamine and serotonin systems.

Basic Information

Product Name	Cariprazine
CAS No.	839712-12-8
Molecular Formula	C21H32ClN3O
Molecular Weight	377.95 g/mol
Synonyms	RGH-188; Trans-3-{4-[2-[4-(2,3-Dichlorophenyl)piperazin-1-yl]ethyl}cyclohexyl)-1H-indole-5-carbonitrile; UNII-FFE6X1J37J; Vraylar (Trade Name); Reagila (Trade Name); Cariprazine Hydrochloride (Salt Form); 5-Cyano-3-[trans-4-[2-[4-(2,3-dichlorophenyl)-1-piperazinyl]ethyl]cyclohexyl]-1H-indole
EINECS	Contact for details

Quality Control

Our Cariprazine is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identification by spectroscopic methods, to ensure it meets stringent pharmaceutical-grade specifications. Certificates of Analysis (COA) detailing all test results against relevant specifications are provided and can be tailored to support GMP, ICH guidelines, and major pharmacopoeia standards (USP/EP) as required.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown 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.