Description

Aprepitant Impurity 9 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antiemetic drug Aprepitant during its development and manufacturing processes. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and manufacturers of active pharmaceutical ingredients (APIs) for method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material for the identification and quantification of Aprepitant Impurity 9 in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Aprepitant API and formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH regulatory 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 necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this impurity.

Basic Information

Product Name	Aprepitant Impurity 9
CAS No.	219821-37-1
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)-4-morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one; Aprepitant Related Compound 9; Fosaprepitant Impurity 9; Emend Impurity 9; (2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-[(5-oxo-1,2-dihydro-3H-1,2,4-triazol-3-yl)methyl]morpholine
EINECS	Contact for details

Quality Control

Our Aprepitant Impurity 9 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Each lot is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity, and related substances by validated methods such as HPLC, NMR, and MS. We support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C limits
Water Content (KF)	≤ 5.0%

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