Description

Aprepitant Impurity 53 is a designated impurity standard used in the analytical profiling and quality control of the antiemetic drug Aprepitant. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of Aprepitant formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Aprepitant Impurity 53 in drug substance and drug product testing.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) and Release Testing: Employed in routine QC laboratories to monitor impurity levels and ensure batch-to-batch consistency of Aprepitant API, complying with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research and Development: Supports synthetic route optimization and process chemistry studies by identifying and controlling process-related impurities.

Basic Information

Product Name	Aprepitant Impurity 53
CAS No.	170902-78-0
Molecular Formula	C23H21F7N4O3
Molecular Weight	534.43 g/mol
Synonyms	1-[(2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]-1H-1,2,4-triazol-5(4H)-one; Aprepitant Related Compound 53; Fosaprepitant Impurity 53; (2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-(5-oxo-4,5-dihydro-1H-1,2,4-triazol-1-yl)morpholine; UNII-9W6C4S8H3R; Emend Impurity 53
EINECS	Contact for details

Quality Control

Our Aprepitant Impurity 53 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. 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. Our quality commitment ensures material suitability for its intended use as a pharmaceutical reference standard.

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 should be handled under dry conditions to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 2.0% 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.