Description

(±)-Duloxetine CAS NO 116817-13-1 is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) of significant pharmaceutical importance. This compound serves as a key intermediate in the synthesis of the active pharmaceutical ingredient (API) duloxetine hydrochloride, a widely prescribed medication. It is essential for pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for major depressive disorder, generalized anxiety disorder, and neuropathic pain. Our product is supplied with a commitment to high purity and reliable supply chain integrity for global B2B partners.

Application

• Pharmaceutical Intermediate: Primary use as a critical building block in the synthesis of the API duloxetine hydrochloride.
• Active Pharmaceutical Ingredient (API) Research: Serves as a reference standard and starting material in R&D for novel SSNRI-based therapeutics.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for scale-up and commercial production.
• Analytical Standard: Used in quality control laboratories for method development, validation, and impurity profiling via HPLC and other techniques.
• Neuropharmacology Studies: Utilized in preclinical research to study the mechanisms of serotonin and norepinephrine reuptake inhibition.

Basic Information

Product Name	(±)-Duloxetine
CAS No.	116817-13-1
Molecular Formula	C18H19NOS
Molecular Weight	297.41 g/mol
Synonyms	(±)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine; (RS)-Duloxetine; LY248686; N-Methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine; (RS)-N-Methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine; Duloxetine Racemate; (+/-)-Duloxetine
EINECS	Contact for details

Quality Control

Our (±)-Duloxetine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profiling, to ensure it meets the stringent requirements for pharmaceutical intermediates. Certificates of Analysis (COA) are provided, detailing purity (typically ≥98% by HPLC), residual solvents, and related substances. We adhere to cGMP principles where applicable to support our global clients' regulatory compliance needs for REACH, FDA submissions, and other international standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed to minimize exposure to atmospheric humidity. Keep away from heat and incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Water Content (KF)	≤ 0.5%
Heavy Metals	≤ 20 ppm

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