Description

2-Phenyl-1-[4-(Trifluoromethyl)Phenyl]Ethane 2-(Aminoethyl)Oxime (Fluvoxamine Impurity) is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity in the synthesis and quality control of Fluvoxamine, a widely prescribed selective serotonin reuptake inhibitor (SSRI). It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards for method development, validation, and regulatory compliance. The availability of this well-characterized impurity is fundamental for ensuring drug safety, efficacy, and meeting stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Fluvoxamine maleate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or GC methods in compliance with ICH Q2(R1) guidelines.
• Pharmacopeial Compliance: Used to demonstrate compliance with impurity limits specified in pharmacopeias such as USP, EP, or JP for Fluvoxamine.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Fluvoxamine.
• Process Chemistry Research: Utilized in research to study and optimize synthetic routes for Fluvoxamine, helping to minimize the formation of this specific impurity.
• Regulatory Submissions: Essential for preparing impurity profiles and supporting documentation for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA and EMA.

Basic Information

Product Name	2-Phenyl-1-[4-(Trifluoromethyl)Phenyl]Ethane 2-(Aminoethyl)Oxime (Fluvoxamine Impurity)
CAS No.	1217241-15-0
Molecular Formula	C17H17F3N2O
Molecular Weight	322.33 g/mol
Synonyms	Fluvoxamine Related Compound; Fluvoxamine Impurity; 1-[4-(Trifluoromethyl)phenyl]-2-phenylethan-1-one O-(2-aminoethyl)oxime; (E/Z)-2-Phenyl-1-[4-(trifluoromethyl)phenyl]ethanone O-(2-aminoethyl)oxime; Fluvoxamine EP Impurity; Fluvoxamine USP Impurity
EINECS	Contact for details

Quality Control

Every batch of 2-Phenyl-1-[4-(Trifluoromethyl)Phenyl]Ethane 2-(Aminoethyl)Oxime is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using techniques such as HPLC, NMR, and MS to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications. We support compliance with cGMP, ICH Q3A/B, and relevant pharmacopeial standards (USP/EP), making this material suitable for regulated laboratory environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. For long-term storage, consider storing under inert atmosphere in a cool, dry place. Keep the container tightly sealed in a dry and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Total Impurities	≤ 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.