Description

Aprepitant Impurity 54 CAS NO 170729-74-5 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the antiemetic drug Aprepitant by serving as a known impurity for analytical method development and validation. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, particularly those involved in the synthesis, purification, and regulatory compliance of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Aprepitant API and finished drug products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles during manufacturing.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Aprepitant meets stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) for drug substance and product stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Aprepitant Impurity 54
CAS No.	170729-74-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aprepitant Related Compound 54; Aprepitant EP Impurity G; Aprepitant USP Impurity; 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; UNII-9J9734D4QO; Aprepitant Impurity 54 (170729-74-5); Fosaprepitant Impurity
EINECS	Contact for details

Quality Control

Every batch of Aprepitant Impurity 54 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with pharmacopeial standards and ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability information.

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 under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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