Description

Duloxetine Hydrochloride is a high-purity active pharmaceutical ingredient (API) with the CAS registry number 136434-34-9. This compound is a critical intermediate and final active substance in the synthesis of modern antidepressant and neuropathic pain management medications. It is primarily required by pharmaceutical manufacturers and advanced research institutions for the development and production of finished dosage forms. Our supply is characterized by stringent quality control, ensuring reliability for global B2B customers in regulated markets.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of antidepressant medications (SNRIs).
• Neuropathic Pain Treatment: Key component in formulations for managing diabetic peripheral neuropathy and fibromyalgia.
• Chemical Synthesis Intermediate: Used in advanced organic synthesis for creating novel therapeutic analogs.
• Reference Standard: Serves as a high-purity standard in analytical laboratories for quality control and method development.
• Clinical Research Material: Supplied for preclinical and clinical trial studies in neurological and psychiatric research.
• Generic Drug Production: Essential for manufacturers producing bioequivalent generic versions of branded medications.

Basic Information

Product Name	Duloxetine Hydrochloride
CAS No.	136434-34-9
Molecular Formula	C18H19NOS•HCl
Molecular Weight	333.86 g/mol
Synonyms	(+)-(S)-N-Methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride; (S)-Duloxetine hydrochloride; LY248686 hydrochloride; Cymbalta (brand name API); Ariclaim; Yentreve; (S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine hydrochloride
EINECS	Contact for details

Quality Control

Our Duloxetine Hydrochloride is manufactured and tested under a quality management system designed for pharmaceutical ingredients. Each batch undergoes comprehensive analysis to ensure it meets stringent specifications for identity, purity, and potency. We provide full traceability and support regulatory filings with detailed documentation. Certificates of Analysis (COA) are available upon request, confirming compliance with relevant pharmacopeial standards (e.g., USP, EP) and customer-specific requirements.

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 light-sensitive; therefore, containers must be kept tightly sealed and away from direct light exposure to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water Content (KF)	NMT 0.5%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Optical Rotation	[α]20/D: +128° to +132° (c=1 in methanol)

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