Description

Duloxetine CAS NO 116539-59-4 is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) widely recognized for its therapeutic efficacy. This compound is of critical importance in the pharmaceutical industry for the development and production of medications targeting major depressive disorder, generalized anxiety disorder, and neuropathic pain. It is an essential active pharmaceutical ingredient (API) for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) globally.

Application

• Primary Active Pharmaceutical Ingredient (API) in antidepressant and anxiolytic medications.
• Key component in the formulation of treatments for diabetic peripheral neuropathic pain (DPNP).
• Used in the manufacture of drugs for fibromyalgia and chronic musculoskeletal pain.
• Critical raw material for pharmaceutical R&D in central nervous system (CNS) disorders.
• Reference standard in analytical laboratories for quality control and method development.
• Intermediate in the synthesis of novel SSNRI derivatives for clinical research.

Basic Information

Product Name	Duloxetine
CAS No.	116539-59-4
Molecular Formula	C18H19NOS
Molecular Weight	297.41 g/mol
Synonyms	(+)-(S)-Duloxetine; (S)-Duloxetine; Duloxetine Hydrochloride; LY248686; Cymbalta; Ariclaim; Xeristar; Yentreve; (S)-N-Methyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propanamine; (S)-N-Methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine
EINECS	Contact for details

Quality Control

Our Duloxetine is manufactured under strict quality management systems. It undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing parameters such as assay, enantiomeric purity, and impurity profiles. We adhere to cGMP guidelines to ensure supply reliability and batch-to-batch consistency for our global partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Enantiomeric Purity (HPLC)	≥ 99.0% (S-isomer)
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.15%, Total impurities ≤ 0.5%

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