Description

Aprepitant Impurity 33 is a designated impurity standard used in the analytical profiling and quality control of the antiemetic drug substance Aprepitant. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, meet stringent regulatory requirements, and validate manufacturing processes. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and contract research organizations (CROs) focused on developing and monitoring active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Aprepitant Impurity 33 in drug substance and finished product analysis.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in accordance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure Aprepitant batches comply with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) with agencies like the FDA and EMA.
• Process Chemistry Research: Aids chemists in understanding and controlling the formation of this impurity during the synthesis and purification of Aprepitant.

Basic Information

Product Name	Aprepitant Impurity 33
CAS No.	502537-39-5
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 33; Aprepitant EP Impurity G; Aprepitant USP Related Compound C; (3R)-5-({(2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl}methyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
EINECS	Contact for details

Quality Control

Every batch of Aprepitant Impurity 33 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatographic data, and traceability information.

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) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
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.