Description

Aprepitant Impurity 10 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 the research, development, and quality assurance processes for Aprepitant and related pharmaceutical formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Aprepitant active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation of degradation products in Aprepitant under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of Aprepitant.

Basic Information

Product Name	Aprepitant Impurity 10
CAS No.	1651828-04-4
Molecular Formula	C23H21F7N4O3
Molecular Weight	534.43 g/mol
Synonyms	1-[(2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]-1H-1,2,4-triazol-5(4H)-one; Aprepitant Related Compound 10; Fosaprepitant Impurity 10; (2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-(5-oxo-4,5-dihydro-1H-1,2,4-triazol-1-yl)morpholine; UNII-8J8F6Q8V8P
EINECS	Contact for details

Quality Control

Every batch of Aprepitant Impurity 10 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, LC-MS, NMR, and IR analyses. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines.

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 at 2-8°C. The material is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
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)	≤ 2.0%

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