Description

Aprepitant Impurity 22 is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the identification, qualification, and control of process-related impurities in the active pharmaceutical ingredient (API) Aprepitant, an antiemetic medication. It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and biotechnology industries. Utilizing this well-characterized impurity standard is fundamental for ensuring drug safety, efficacy, and compliance with stringent global regulatory guidelines.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities during Aprepitant API development and manufacturing.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control and Release Testing: Employed in routine QC testing of Aprepitant drug substance and drug products to monitor impurity levels against established specifications.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the API's impurity profile.
• Stability Studies: Used to track the formation of this specific impurity over time under various stress conditions to establish product shelf-life.
• Research and Development: Facilitates chemical and process research aimed at understanding impurity formation pathways and optimizing synthesis to minimize its presence.

Basic Information

Product Name	Aprepitant Impurity 22
CAS No.	934540-48-4
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]methyl]-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3-a]pyrazin-4-ium; Aprepitant Related Compound 22; Aprepitant EP Impurity I; Aprepitant USP Related Compound C; EMEND Impurity 22; MK-0869 Impurity 22
EINECS	Contact for details

Quality Control

Our Aprepitant Impurity 22 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. The quality control protocols are designed to support compliance with ICH Q3A, Q3B, and Q6A guidelines, ensuring suitability for use in regulatory submissions and GMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; ensure the container is sealed tightly after each use to minimize exposure to atmospheric moisture and light.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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