Description

Aprepitant Impurity 26 is a designated impurity standard used in the pharmaceutical development and quality control of Aprepitant, a neurokinin-1 (NK1) receptor antagonist. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Aprepitant API and its finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to establish, optimize, and validate chromatographic methods for impurity profiling and identification.
• Quality Control & Batch Release Testing: Essential for monitoring and controlling impurity levels in commercial Aprepitant batches to meet pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed as a marker to track impurity formation during forced degradation and long-term stability studies of Aprepitant.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in R&D to understand the degradation pathways and synthesis-related impurities of Aprepitant.

Basic Information

Product Name	Aprepitant Impurity 26
CAS No.	2410426-96-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aprepitant Related Compound 26; Aprepitant Impurity; Fosaprepitant Impurity 26; (2R,4S)-4-[(3,5-Bis(trifluoromethyl)benzyl)oxy]-2-(4-fluoro-2-methylphenyl)-N-methyl-1-(4-(methylsulfonyl)piperazin-1-yl)-3,4-dihydro-2H-naphthalene-1-carboxamide Impurity; Emend Impurity 26; MK-0869 Impurity 26; Neurokinin-1 Receptor Antagonist Impurity
EINECS	Contact for details

Quality Control

Our Aprepitant Impurity 26 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, LC-MS, and NMR, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality standards align with ICH guidelines to support your regulatory requirements.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

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

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