Description

Aprepitant Impurity 42 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antiemetic drug Aprepitant by serving as a key marker for impurity profiling and control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards and regulatory compliance in pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Aprepitant Impurity 42 in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Essential for developing and validating robust analytical methods, such as HPLC and UPLC, for impurity detection in Aprepitant.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control impurity levels during Aprepitant manufacturing to ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity understanding and control strategies.
• Research and Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis routes for Aprepitant.

Basic Information

Product Name	Aprepitant Impurity 42
CAS No.	172678-47-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aprepitant Related Compound 42; Aprepitant EP Impurity G; Fosaprepitant Impurity 42; (3R,5S)-5-[(2R)-1-[3,5-Bis(trifluoromethyl)benzyl]-2-(4-fluorophenyl)-4-(morpholin-4-yl)piperidin-3-yl]-3-(2-methylpropyl)-2,4-dihydro-1,2,4-triazol-3-one; MK-0869 Impurity 42; Emend Impurity 42; 1,2,4-Triazol-3-one derivative of Aprepitant
EINECS	Contact for details

Quality Control

Our Aprepitant Impurity 42 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including identification by spectroscopic methods (IR, NMR, MS) and purity assessment by advanced chromatographic techniques (HPLC, UPLC) to ensure it meets high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality needs.

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 product is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. Ensure the storage area is well-ventilated and separate from incompatible materials.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.