Description

Fluoxetine Impurity 29, Methyl({3-Phenyl-3-[2-(Trifluoromethyl)Phenoxy]Propyl})Amine is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the synthesis and quality control of Fluoxetine, a widely used antidepressant. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards for method validation, stability studies, and regulatory compliance. Ensuring the integrity of your analytical data starts with sourcing well-characterized impurities like this one.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and GC-MS analysis of Fluoxetine API and finished dosage forms.
• Method Development and Validation: Critical for developing and validating analytical methods to monitor and control this specific impurity during manufacturing.
• Stability Indicating Studies: Used in forced degradation and long-term stability studies to identify and quantify degradation products of Fluoxetine.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and CMC sections.
• Quality Control (QC) Testing: Employed in routine QC laboratories to ensure Fluoxetine batches meet stringent pharmacopeial purity specifications (e.g., USP, EP).
• Research and Development: Used in synthetic chemistry R&D to study reaction pathways and optimize processes to minimize impurity formation.

Basic Information

Product Name	Fluoxetine Impurity 29, Methyl({3-Phenyl-3-[2-(Trifluoromethyl)Phenoxy]Propyl})Amine
CAS No.	56161-71-8
Molecular Formula	C17H18F3NO
Molecular Weight	309.33 g/mol
Synonyms	Fluoxetine Impurity 29; N-Methyl-3-phenyl-3-[2-(trifluoromethyl)phenoxy]propan-1-amine; N-Methyl-3-phenyl-3-[α,α,α-trifluoro-o-tolyloxy]propylamine; 1-Phenyl-3-[2-(trifluoromethyl)phenoxy]-N-methylpropan-1-amine; Methyl({3-Phenyl-3-[2-(Trifluoromethyl)Phenoxy]Propyl})Amine; Prozac Impurity 29; Fluoxetine Related Compound 29
EINECS	Contact for details

Quality Control

Every batch of Fluoxetine Impurity 29 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use in regulated environments.

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); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5%
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.