Description

Aprepitant Impurity 19 is a designated impurity standard used in the pharmaceutical development and quality control of Aprepitant, a neurokinin-1 (NK1) receptor antagonist. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference marker in analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, purification, and batch release of Aprepitant and its formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Aprepitant Impurity 19 in drug substance and drug product.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Assurance & Control (QA/QC): Employed in routine batch testing to monitor impurity profiles and ensure compliance with International Council for Harmonisation (ICH) guidelines on impurities in new drug substances.
• 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., to FDA, EMA) to demonstrate control over the impurity profile of Aprepitant.
• Process Chemistry Research: Aids chemists in identifying and eliminating the source of this impurity during the API synthesis and purification process development.

Basic Information

Product Name	Aprepitant Impurity 19
CAS No.	648425-56-3
Molecular Formula	C23H21F7N4O3
Molecular Weight	534.43 g/mol
Synonyms	5-[[(2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one; Aprepitant Related Compound 19; Aprepitant EP Impurity I; Aprepitant USP Related Compound I; (αR)-α-[(2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-5H-1,2,4-triazol-3-one
EINECS	Contact for details

Quality Control

Every batch of Aprepitant Impurity 19 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

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 guidelines
Water Content (KF)	≤ 5.0% w/w

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