Description

Cariprazine Hydrochloride is a high-purity active pharmaceutical ingredient (API) and a key intermediate in the synthesis of modern antipsychotic medications. Its primary value lies in its critical role as the active component in the treatment of schizophrenia and bipolar disorder, demanding the highest standards of chemical purity and consistency. This compound is essential for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the development and production of central nervous system (CNS) therapeutics.

Application

• Pharmaceutical API Production: Primary use as the active ingredient in the formulation of finished dosage forms for antipsychotic drugs.
• Clinical Research & Development: Serves as a reference standard and key material in preclinical and clinical studies for new CNS therapies.
• Generic Drug Manufacturing: Critical for companies developing bioequivalent versions of branded antipsychotic medications containing cariprazine.
• Process Development & Scale-Up: Used by CDMOs and in-house R&D teams to optimize synthesis routes and manufacturing processes.
• Analytical Method Development: Employed as a standard for HPLC, LC-MS, and other analytical techniques to ensure product quality and regulatory compliance.

Basic Information

Product Name	Cariprazine Hydrochloride
CAS No.	1083076-69-0
Molecular Formula	C21H33Cl2N3O • HCl
Molecular Weight	464.88 g/mol
Synonyms	RGH-188 Hydrochloride; Trans-3-[[4-[2-[4-(2,3-Dichlorophenyl)-1-piperazinyl]ethyl]cyclohexyl]methyl]-1,2,4-oxadiazol-5-amine Hydrochloride; UNII-3P8V6L5P8B; Vraylar (Brand Name Salt Form); Cariprazine HCl; (1R,2R,3S,5S)-3-[[4-[2-[4-(2,3-Dichlorophenyl)piperazin-1-yl]ethyl]cyclohexyl]methyl]-1,2,4-oxadiazol-5-amine hydrochloride
EINECS	Contact for details

Quality Control

Our Cariprazine Hydrochloride is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for assay and impurity profiling, residual solvent analysis, and identification tests, to ensure it meets stringent pharmaceutical-grade specifications. A Certificate of Analysis (COA) detailing all test results against predefined specifications is provided with every shipment to guarantee traceability, purity, and regulatory compliance for GMP-driven applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled and stored accordingly to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single unknown impurity ≤ 0.2%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%
Heavy Metals	≤ 20 ppm

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