Description

Duloxetine CAS NO 116539-58-3 is a high-purity active pharmaceutical ingredient (API) belonging to the class of serotonin-norepinephrine reuptake inhibitors (SNRIs). It is a critical compound for the development and manufacture of effective antidepressant and neuropathic pain management medications. This product is essential for pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the production of finished dosage forms.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of antidepressant medications.
• Major Depressive Disorder (MDD) Treatment: Used in formulations for the management of major depressive disorder.
• Generalized Anxiety Disorder (GAD) Treatment: Key component in medications prescribed for generalized anxiety disorder.
• Diabetic Peripheral Neuropathic Pain (DPNP) Management: Essential for producing drugs that alleviate pain associated with diabetic neuropathy.
• Fibromyalgia Treatment: Used in the synthesis of medications for managing chronic widespread pain.
• Research & Development: Serves as a reference standard and building block in preclinical and clinical pharmaceutical research.
• Generic Drug Manufacturing: Critical for companies producing bioequivalent generic versions of branded SNRI medications.

Basic Information

Product Name	Duloxetine
CAS No.	116539-58-3
Molecular Formula	C18H19NOS
Molecular Weight	297.41 g/mol
Synonyms	(+)-(S)-N-Methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride; (S)-Duloxetine; LY248686; Cymbalta (brand name); Ariclaim; Xeristar; Yentreve; (S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine
EINECS	Contact for details

Quality Control

Our Duloxetine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters 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, which can affect stability and handling properties.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity ≤ 0.15%, Total impurities ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details

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