Description

Duloxetine Maleate CAS NO 116817-86-8 is a high-purity pharmaceutical intermediate, specifically the maleate salt form of the active pharmaceutical ingredient duloxetine. This compound is a critical building block in the synthesis of finished dosage forms for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), and neuropathic pain. It is essential for manufacturers in the global pharmaceutical and fine chemical industries requiring reliable, high-quality raw materials for API production. Our product is supplied under stringent quality control to ensure consistency and compliance with cGMP standards.

Application

• Active Pharmaceutical Ingredient (API) Synthesis: Primary use as a key intermediate in the commercial-scale manufacturing of duloxetine hydrochloride, the final API.
• Pharmaceutical Research & Development: Serves as a crucial reference standard and starting material in preclinical and clinical research for central nervous system (CNS) therapeutics.
• Generic Drug Manufacturing: Used by generic pharmaceutical companies to produce cost-effective versions of branded antidepressant and analgesic medications.
• Contract Manufacturing Organizations (CMOs): Supplied to CMOs and CDMOs specializing in the production of complex, small-molecule drugs.
• Analytical Standard: Employed in quality control laboratories for method development, validation, and routine assay testing via HPLC and other chromatographic techniques.

Basic Information

Product Name	Duloxetine Maleate
CAS No.	116817-86-8
Molecular Formula	C22H27NO5
Molecular Weight	385.46 g/mol
Synonyms	(+)-(S)-N-Methyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propanamine maleate; (S)-Duloxetine maleate; LY248686 maleate; N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine (2Z)-but-2-enedioate; Cymbalta intermediate
EINECS	Contact for details

Quality Control

Our Duloxetine Maleate is manufactured in facilities operating under current Good Manufacturing Practice (cGMP) guidelines. Each batch undergoes comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis, to ensure it meets stringent pharmacopeial standards. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with agreed specifications for identity, purity, and strength.

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) and must be kept under dry, inert conditions to prevent degradation. Keep away from heat and incompatible materials.

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)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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