Description

Fosaprepitant n-Benzyl Impurity is a high-purity reference standard used in the pharmaceutical development and quality control of antiemetic drugs. This compound is critical for ensuring the safety and efficacy of active pharmaceutical ingredients by serving as a key marker for process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis and validation of Fosaprepitant and its prodrug formulations. The availability of this well-characterized impurity standard is essential for meeting stringent regulatory requirements for drug approval and batch release.

Application

• Primary use as a pharmaceutical reference standard for analytical method development and validation (HPLC, LC-MS).
• Critical component in impurity profiling and stability studies of Fosaprepitant drug substance and drug products.
• Essential for quality control (QC) and in-process testing during the synthesis of Fosaprepitant to monitor and control specific process impurities.
• Used in regulatory submissions (e.g., FDA, EMA) to identify and qualify impurities as per ICH guidelines Q3A(R2) and Q3B(R2).
• Serves as a research tool in pharmacokinetic and metabolic studies to understand degradation pathways.
• Applied in the calibration and qualification of laboratory equipment for precise impurity quantification.

Basic Information

Product Name	Fosaprepitant n-Benzyl Impurity
CAS No.	2035475-10-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fosaprepitant Benzyl Impurity; Fosaprepitant Related Compound n-Benzyl; n-Benzyl Fosaprepitant Impurity; Fosaprepitant Process Impurity; Aprepitant Prodrug Impurity; NK-1 Receptor Antagonist Impurity; CAS 2035475-10-4
EINECS	Contact for details

Quality Control

Our Fosaprepitant n-Benzyl Impurity is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting identity, purity, and impurity profiles. Our quality commitment aligns with the principles of current Good Manufacturing Practice (cGMP) for active pharmaceutical ingredients (APIs) and excipients.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.