Description

Fosaprepitant Impurity 4 is a designated impurity standard used in the pharmaceutical development and quality control of Fosaprepitant, a prodrug of the antiemetic Aprepitant. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of this specific process-related impurity. It is an essential tool for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development, validation, and routine quality control testing of Fosaprepitant drug substance and drug products.
• Analytical Method Development: Used to establish and optimize chromatographic conditions (e.g., HPLC, UPLC) for the precise separation and detection of Fosaprepitant Impurity 4 from the main API and other related substances.
• Stability Studies: Employed as a marker to monitor the formation and levels of this impurity during forced degradation and long-term stability studies of Fosaprepitant formulations.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Fosaprepitant by identifying the source and mechanism of formation for this impurity.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for quantitative impurity analysis in batch release testing to ensure product specifications are met.

Basic Information

Product Name	Fosaprepitant Impurity 4
CAS No.	1523569-85-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fosaprepitant Related Compound 4; Fosaprepitant Impurity; Aprepitant Prodrug Impurity; (3-(((2R,3S)-2-((R)-1-(3,5-Bis(trifluoromethyl)phenyl)ethoxy)-3-(4-fluorophenyl)morpholino)methyl)-5-oxo-4,5-dihydro-1H-1,2,4-triazol-1-yl)phosphonic Acid (proposed); Fosaprepitant Process Impurity; NK-1 Receptor Antagonist Impurity; Emend® Impurity Standard
EINECS	Contact for details

Quality Control

Our Fosaprepitant Impurity 4 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, 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. Our quality commitment aligns with the needs of cGMP-compliant pharmaceutical development.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.