Description

Aprepitant Ep Impurity C is a designated impurity reference standard used in the analytical profiling and quality control of the antiemetic drug Aprepitant. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and compliance testing of Aprepitant formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Aprepitant Ep Impurity C in Aprepitant API and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity levels and ensure batch-to-batch consistency in Aprepitant manufacturing.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity profiles as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation and increase of this specific impurity during forced degradation and long-term stability studies of Aprepitant.
• Research and Development: Aids in the chemical and process development of Aprepitant by helping to understand and control impurity formation pathways.

Basic Information

Product Name	Aprepitant Ep Impurity C
CAS No.	2208275-99-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aprepitant Related Compound C; Aprepitant Impurity C; Fosaprepitant Impurity C; (3R)-1-[(2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholin-4-yl]methanone; MK-0869 Impurity C; Emend Impurity C; Neurokinin-1 Receptor Antagonist Impurity
EINECS	Contact for details

Quality Control

Our Aprepitant Ep Impurity C is produced and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including identity confirmation by spectroscopic methods and purity determination by HPLC, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.