Description

Aprepitant Ep Impurity B is a designated impurity standard used in the analytical profiling and quality control of the antiemetic drug Aprepitant. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and as a reference standard in chromatographic analysis for the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Aprepitant Ep Impurity B in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Essential for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor impurity levels and ensure Aprepitant API meets stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of this specific impurity during forced degradation and long-term stability studies of Aprepitant formulations.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Research and Development: Used in synthetic chemistry R&D to understand and control impurity formation pathways during the Aprepitant manufacturing process.

Basic Information

Item	Details
Product Name	Aprepitant Ep Impurity B
CAS No.	2348441-62-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-[[(2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholin-4-yl]methyl]-1H-1,2,4-triazol-3-one; Aprepitant Impurity B; Aprepitant EP Impurity B; Aprepitant Related Compound B; Fosaprepitant Impurity B
EINECS	Contact for details

Quality Control

Our Aprepitant Ep Impurity B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and determination of residual solvents and moisture content. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing all test results against predefined specifications. Our quality standards align with ICH guidelines to support your regulatory requirements.

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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual impurity ≤ 2.0%
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.