Description

Duloxetine Related Compound F (10 Mg) ((S)-n-Methyl-3-(Naphthalen-1-Yloxy)-3-(Thiophen-3-Yl)Propan-1-Amine Hydrochloride) is a high-purity chemical reference standard critical for analytical research and quality control. This compound serves as a key impurity marker and process intermediate in the synthesis and validation of the antidepressant drug, duloxetine. It is essential for pharmaceutical R&D and QC laboratories to ensure product purity, safety, and regulatory compliance. The material is supplied as a precisely weighed 10 mg sample, facilitating accurate and convenient use in chromatographic and spectroscopic analyses.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in duloxetine active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and GC methods to monitor impurities and ensure method specificity and accuracy.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to confirm that duloxetine batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Used to track the formation of degradation products in duloxetine formulations under various stress conditions (heat, light, humidity).
• Process Chemistry Research: Acts as a marker to study and optimize synthetic pathways for duloxetine, helping to minimize the formation of this specific impurity.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the manufacturing process.

Basic Information

Product Name	Duloxetine Related Compound F (10 Mg) ((S)-n-Methyl-3-(Naphthalen-1-Yloxy)-3-(Thiophen-3-Yl)Propan-1-Amine Hydrochloride)
CAS No.	1104890-90-5
Molecular Formula	C18H20ClNOS
Molecular Weight	333.87 g/mol
Synonyms	(S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-amine hydrochloride; Duloxetine Impurity F; Duloxetine Related Substance F; (S)-3-(Methylamino)-1-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-one hydrochloride; LY248686 Related Compound F; (S)-1-(Naphthalen-1-yloxy)-3-(thiophen-3-yl)-3-(methylamino)propan-1-one hydrochloride
EINECS	Contact for details

Quality Control

This high-grade reference material is produced under strict quality management systems. Each batch is characterized using advanced analytical techniques including HPLC, GC, NMR, and mass spectrometry to confirm identity and purity. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, including retention time and relative response factor where applicable. Our quality protocols are designed to support compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines for impurity profiling.

Storage

Preserve in the original, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and light-sensitive; prolonged exposure to air, moisture, or light should be avoided to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%
Assay (on dried basis)	97.0% - 103.0%

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