Description

Cariprazine Impurity 3 CAS NO 791778-53-5 is a designated impurity standard used in the analytical profiling and quality control of the antipsychotic active pharmaceutical ingredient (API) Cariprazine. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Cariprazine Impurity 3 in Cariprazine API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor and control impurity levels according to ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Serves as a critical component in routine QC testing to ensure API and drug product batches meet stringent purity specifications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Used in synthetic chemistry R&D to understand and optimize the Cariprazine manufacturing process to minimize impurity formation.

Basic Information

Product Name	Cariprazine Impurity 3
CAS No.	791778-53-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cariprazine Related Compound 3; Cariprazine Impurity C; Cariprazine Process Impurity; (3R,4R)-1-[(1R,2R)-2-[4-(2,3-Dichlorophenyl)piperazin-1-yl]cyclohexyl]-3,4-dimethylpyrrolidin-2-one (tentative); UNII-Contact for details; Cariprazine Specified Impurity; Cariprazine Degradant
EINECS	Contact for details

Quality Control

Our Cariprazine Impurity 3 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Quality is assured through comprehensive methods including HPLC, LC-MS, and NMR. A detailed Certificate of Analysis (COA) is provided with each batch, confirming compliance with in-house specifications aligned with ICH guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if specified.

Specification

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

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