Description

Aprepitant Impurity 1 CAS NO 638990-20-2 is a designated impurity standard used in the analytical profiling of the antiemetic drug Aprepitant. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and stringent quality control processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Aprepitant API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing, optimizing, and validating chromatographic methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine QC testing to monitor impurity levels and ensure batches meet pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and control strategies.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation during the Aprepitant manufacturing process.

Basic Information

Item	Details
Product Name	Aprepitant Impurity 1
CAS No.	638990-20-2
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; Fosaprepitant Impurity; MK-0869 Impurity; Emend Impurity; (3aR,4S,7aS)-4-[[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]methyl]-7-(4-fluorophenyl)-2,3,3a,4,7,7a-hexahydro-1H-isoindole-1,3(2H)-dione derivative; Aprepitant Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Aprepitant Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with the highest standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatographic data, and traceability information.

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 material should be handled in a low-humidity environment and the container kept sealed to prevent moisture absorption.

Specification

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

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