Description

Aprepitant Impurity 12 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 12 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) Testing: Employed in routine batch release testing to monitor impurity levels and ensure compliance with International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Aprepitant Impurity 12
CAS No.	172673-23-3
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 12; Fosaprepitant Impurity 12; Emend Impurity 12; (2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-[(5-oxo-1,2-dihydro-3H-1,2,4-triazol-3-yl)methyl]morpholine
EINECS	Contact for details

Quality Control

Our Aprepitant Impurity 12 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with current pharmacopeial expectations and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, related substances, residual solvents, and identification (IR, MS).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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