Description

Aprepitant Impurity 17 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antiemetic drug Aprepitant during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and contract research organizations (CROs) for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Aprepitant drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Aprepitant meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions to determine drug product shelf-life.
• Regulatory Submissions: Provides essential data for filing regulatory documents (e.g., CMC sections for FDA, EMA) by characterizing and controlling known impurities.
• Chemical Research: Acts as a building block or intermediate for researchers studying the synthesis, degradation pathways, or metabolism of Aprepitant and related compounds.

Basic Information

Product Name	Aprepitant Impurity 17
CAS No.	1333998-27-8
Molecular Formula	C23H21F7N4O3
Molecular Weight	534.43 g/mol
Synonyms	1-Deoxy-1-(methylamino)-D-glucitol Aprepitant Impurity; Aprepitant Related Compound 17; (2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholine-4-carboxamide Impurity; Fosaprepitant Impurity 17; Emend Impurity 17; MK-0869 Impurity 17; 4-Morpholinecarboxamide, 2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-, (2R,3S)-
EINECS	Contact for details

Quality Control

Our Aprepitant Impurity 17 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, residual solvent analysis, and identity confirmation (IR, MS), to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% 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.