Description

Netupitant Impurity CAS NO 2347562-52-9 is a high-purity chemical reference standard used in the pharmaceutical development and manufacturing process. This compound is critical for the analytical characterization, method validation, and quality control of the antiemetic drug Netupitant. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in regulatory compliance and ensuring drug substance purity.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Netupitant active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling and stability-indicating assays.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed as a marker to track impurity formation during forced degradation and long-term stability studies of Netupitant formulations.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the main drug substance.

Basic Information

Product Name	Netupitant Impurity
CAS No.	2347562-52-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Netupitant Related Compound; Netupitant Impurity Standard; Netupitant Process Impurity; AKYNZEO Impurity; (2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluoro-2-methylphenyl)morpholine Impurity; 2347562-52-9; UNII-Contact for details
EINECS	Contact for details

Quality Control

Every batch of Netupitant Impurity CAS NO 2347562-52-9 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, GC, and NMR, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment and handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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.