Description

Aprepitant Ep Impurity B CAS NO 2206606-86-0 is a high-purity reference standard specifically identified as a process-related impurity of Aprepitant, a neurokinin-1 (NK1) receptor antagonist. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this specific impurity during drug substance manufacturing. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, supporting method validation, stability studies, and regulatory compliance for Aprepitant API production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Aprepitant.
• Method Development and Validation (HPLC/LC-MS): Critical for developing and validating chromatographic methods to monitor and control impurity profiles.
• Quality Control and Release Testing: Used in the routine testing of Aprepitant Active Pharmaceutical Ingredient (API) batches to ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions and over shelf life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Aprepitant synthesis pathway to minimize the formation of this impurity.

Basic Information

Item	Detail
Product Name	Aprepitant Ep Impurity B
CAS No.	2206606-86-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aprepitant EP Impurity B; Aprepitant Related Compound B; Aprepitant Impurity B; (2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholine; UNII-9J9734D4QN; 9J9734D4QN; Aprepitant Diastereomer Impurity
EINECS	Contact for details

Quality Control

Every batch of Aprepitant Ep Impurity B is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive analytical testing, including advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques, to confirm identity and ensure high purity suitable for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines.

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 must be kept tightly sealed in a dry environment to prevent moisture absorption, which could affect stability and analytical performance.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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