Description

Duloxetine n-Desmethyl Metabolite is a key pharmacologically active metabolite of the antidepressant and analgesic drug, Duloxetine. This compound is of critical importance for pharmaceutical research and development, particularly in the areas of drug metabolism studies, pharmacokinetic profiling, and bioanalytical method validation. It serves as an essential reference standard for laboratories in the pharmaceutical and contract research organization (CRO) sectors, enabling accurate quantification and characterization of Duloxetine's metabolic pathway in biological samples.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for qualitative and quantitative analysis in drug development.
• Metabolite Identification & Profiling: Critical for in-vitro and in-vivo studies to map the metabolic fate of Duloxetine.
• Bioanalytical Method Development: Used as a calibration standard in LC-MS/MS and HPLC methods for therapeutic drug monitoring (TDM) and pharmacokinetic (PK) studies.
• Impurity Characterization: Serves as a specified impurity standard in the quality control of Duloxetine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Clinical Research: Supports studies investigating inter-individual variability in Duloxetine metabolism and its correlation with efficacy or side effects.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) requiring comprehensive metabolite safety assessment.

Basic Information

Product Name	Duloxetine n-Desmethyl Metabolite
CAS No.	178273-35-3
Molecular Formula	C17H17NOS
Molecular Weight	283.39 g/mol
Synonyms	(+)-(S)-N-Methyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propanamine; LY 227942; Desmethyl Duloxetine; Duloxetine Metabolite; (S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine; 3-(1-Naphthyloxy)-3-(2-thienyl)-N-methylpropylamine; (S)-Duloxetine N-Desmethyl Metabolite
EINECS	Contact for details

Quality Control

Our Duloxetine n-Desmethyl Metabolite is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, chiral analysis, and structural confirmation (NMR, MS). We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on identity, purity, and impurities. Our quality commitment ensures the material is suitable for its intended use as a high-purity reference standard in regulated 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. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Chiral Purity	≥ 99.0% ee
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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