Description

Aprepitant Impurity CAS NO 96730-04-0 is a high-purity reference standard used in the analytical profiling and quality control of the antiemetic drug Aprepitant. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential material for method development, validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Aprepitant active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles throughout the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Aprepitant meets stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B) for related substances.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) to establish shelf life and proper storage conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over impurity levels.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic route development and process optimization for Aprepitant manufacturing.

Basic Information

Product Name	Aprepitant Impurity
CAS No.	96730-04-0
Molecular Formula	C23H21F7N4O3
Molecular Weight	534.43 g/mol
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; Fosaprepitant Impurity; Emend Impurity; MK-0869 Impurity; Substance P Neurokinin 1 Receptor Antagonist Impurity
EINECS	Contact for details

Quality Control

Every batch of Aprepitant Impurity CAS 96730-04-0 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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