Description

Cariprazine Impurity 4 is a designated process-related impurity and degradation product of the atypical antipsychotic drug Cariprazine. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure the purity, safety, and efficacy of Cariprazine drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cariprazine active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, to separate and detect related substances.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides necessary data on impurity characterization and control strategies for regulatory filings with agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding the synthetic pathway of Cariprazine, helping to identify and minimize the formation of this impurity during manufacturing.

Basic Information

Product Name	Cariprazine Impurity 4
CAS No.	1231947-90-2
Molecular Formula	C21H32ClN3O
Molecular Weight	377.95 g/mol
Synonyms	Cariprazine Related Compound 4; Desmethyl Cariprazine; 3-[[4-[2-[4-(2,3-Dichlorophenyl)piperazin-1-yl]ethyl]cyclohexyl]methyl]pyrimidin-2-one; UNII-8P5F8VU1QO; Cariprazine Impurity D; Cariprazine EP Impurity D; Cariprazine USP Impurity D; Vraylar Impurity 4
EINECS	Contact for details

Quality Control

Every batch of Cariprazine Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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