Description

Dapoxetine Impurity 1 is a high-purity reference standard used in the pharmaceutical development and quality control of Dapoxetine hydrochloride. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily utilized by analytical laboratories, research institutions, and pharmaceutical manufacturers involved in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Dapoxetine API and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods such as HPLC and UPLC.
• Stability Indicating Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control (QC) and Quality Assurance (QA): Essential for routine batch release testing to ensure impurity levels are within specified regulatory limits.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation.

Basic Information

Product Name	Dapoxetine Impurity 1
CAS No.	2825577-69-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapoxetine Related Compound 1; Dapoxetine Impurity; Dapoxetine EP Impurity 1; Dapoxetine USP Impurity; Priligy Impurity 1; (S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine Impurity; Dapoxetine Hydrochloride Impurity A
EINECS	Contact for details

Quality Control

Our Dapoxetine Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, residual solvent analysis, and structural confirmation (NMR, MS), to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) with detailed chromatographic data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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