Description

5-Hydroxy-6-Methoxy Duloxetine Sulfate Sodium Salt is a key pharmaceutical intermediate and reference standard in the synthesis of active pharmaceutical ingredients (APIs). This compound is of significant value for research and development, particularly in the production and quality control of neuropharmacological agents. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and R&D institutions focused on central nervous system (CNS) therapeutics.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of duloxetine and related therapeutic compounds.
• Reference Standard: Used for analytical method development, validation, and quality control (QC) testing in pharmaceutical manufacturing.
• Metabolite Studies: Employed in pharmacokinetic and metabolic pathway research for duloxetine.
• Impurity Standard: Serves as a certified reference material for identifying and quantifying related substances in API batches.
• Research & Development: Utilized in preclinical and clinical research for developing new CNS-targeting medications.
• Process Chemistry: Applied in scaling up and optimizing synthetic routes for duloxetine production.

Basic Information

Product Name	5-Hydroxy-6-Methoxy Duloxetine Sulfate Sodium Salt
CAS No.	662149-10-2
Molecular Formula	C18H19NO3 • H2SO4 • Na
Molecular Weight	Contact for details
Synonyms	Duloxetine Impurity; Duloxetine Related Compound; (S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine Sulfate Sodium Salt; 5-Hydroxy-6-Methoxy Duloxetine Sodium Salt; Duloxetine Metabolite Salt; LY248686 Sulfate Sodium Salt; (S)-Duloxetine Sulfate Sodium Salt Derivative
EINECS	Contact for details

Quality Control

Our 5-Hydroxy-6-Methoxy Duloxetine Sulfate Sodium Salt is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets stringent specifications for pharmaceutical use. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Water Content	≤ 2.0%
Residue on Ignition	Contact for details
Heavy Metals	< 20 ppm
Related Substances (HPLC)	Total impurities < 2.0%; Individual unknown impurity < 0.5%

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