Description

Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) specifically developed for the treatment of premature ejaculation (PE) in men. Its primary value lies in its rapid onset of action and short half-life, making it suitable for on-demand use. This active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers developing and producing prescription medications for urological and sexual health conditions. Dapoxetine CAS NO 119356-77-3 represents a critical component in the formulation of effective, clinically-proven treatments.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for the treatment of premature ejaculation (PE).
• Finished Dosage Form Manufacturing: Formulated into oral tablets, typically in strengths of 30 mg and 60 mg, for on-demand therapeutic use.
• Clinical Research & Development: Serves as a reference standard and raw material for new drug development, bioavailability studies, and generic drug applications.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of branded and generic pharmaceuticals.
• Regulatory Submissions: Used in the preparation of dossiers for regulatory authorities such as the FDA, EMA, and other global health agencies.

Basic Information

Product Name	Dapoxetine
CAS No.	119356-77-3
Molecular Formula	C21H23NO
Molecular Weight	305.41 g/mol
Synonyms	(+)-(S)-N,N-Dimethyl-α-[2-(1-naphthalenyloxy)ethyl]benzene methanamine; Dapoxetine Hydrochloride; LY 210448; Priligy (Brand Name); (S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine; (S)-Dapoxetine
EINECS	Contact for details

Quality Control

Our Dapoxetine is manufactured under strict quality management systems. Every batch undergoes comprehensive analytical testing to ensure it meets the highest standards for pharmaceutical active ingredients, including identity, purity, and impurity profiles. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting compliance with agreed specifications. We support regulatory requirements and can supply materials suitable for use in GMP-compliant manufacturing processes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Optical Rotation	Specific range provided on COA

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