Description

Fluoxetine Impurity 29 is a designated impurity associated with the active pharmaceutical ingredient Fluoxetine HCl. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is essential for ensuring the purity, safety, and efficacy of Fluoxetine-based drug products. This high-purity standard is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control and compliance purposes.

Application

• Primary use as a certified reference standard for the identification and quantification of Fluoxetine-related impurities.
• Critical component in analytical method development and validation (HPLC, LC-MS) for Fluoxetine HCl API and finished dosage forms.
• Essential for pharmaceutical quality control (QC) and stability studies to monitor impurity profiles.
• Used in regulatory compliance and submission dossiers to meet ICH guidelines (Q3A, Q3B) on impurities.
• Valuable for research and development into the degradation pathways and metabolism of Fluoxetine.
• Supports pharmacopoeial testing to ensure compliance with USP, EP, or other pharmacopoeia monographs.

Basic Information

Product Name	Fluoxetine Impurity 29
CAS No.	2243504-22-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fluoxetine Related Compound 29; Fluoxetine EP Impurity 29; Fluoxetine USP Impurity 29; Fluoxetine Process Impurity 29; Fluoxetine Degradation Product 29; N-Methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine Impurity; (RS)-N-Methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine Impurity 29
EINECS	Contact for details

Quality Control

Our Fluoxetine Impurity 29 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to confirm identity and ensure high purity suitable for use as a reference standard. We provide full traceability and detailed Certificates of Analysis (COA) with each shipment, which include batch-specific results for all critical parameters. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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