Description

Aprepitant Impurity 44 is a high-purity reference standard of a specified impurity associated with the active pharmaceutical ingredient Aprepitant. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable standards to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Aprepitant drug substance and finished dosage forms.
• Analytical Method Development: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation of degradation products under various stress conditions during drug product shelf-life studies.
• Research & Development: Facilitates process chemistry optimization by identifying and characterizing synthetic impurities.

Basic Information

Product Name	Aprepitant Impurity 44
CAS No.	172676-88-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aprepitant Related Compound 44; Aprepitant EP Impurity I; Aprepitant USP Related Compound; 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; Emend Impurity 44; Fosaprepitant Impurity 44; L-754030 Impurity 44; MK-0869 Impurity 44
EINECS	Contact for details

Quality Control

Every batch of Aprepitant Impurity 44 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.