Description

Dapoxetine Impurity 4 Hcl is a high-purity chemical 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 drug product by serving as a benchmark for impurity identification and quantification. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in the synthesis, process optimization, and batch release testing of Dapoxetine-based formulations.

Application

• Primary use as a pharmaceutical reference standard for the identification and control of process-related impurities in Dapoxetine HCl API.
• Critical component in analytical method development and validation (HPLC, LC-MS) for regulatory filings.
• Essential for stability studies and forced degradation studies to monitor impurity profiles over time.
• Used in quality control laboratories for routine batch testing to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Valuable tool for research and development chemists to understand synthetic pathways and optimize purification processes.
• Serves as a calibration standard in quantitative impurity analysis for accurate reporting.

Basic Information

Product Name	Dapoxetine Impurity 4 Hcl
CAS No.	119357-39-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapoxetine Related Compound 4; Dapoxetine HCl Impurity 4; Dapoxetine Hydrochloride Impurity 4; (S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine Hydrochloride Impurity; Dapoxetine Process Impurity; Dapoxetine Specified Impurity; Dapoxetine EP Impurity 4; Dapoxetine USP Impurity 4
EINECS	Contact for details

Quality Control

Every batch of Dapoxetine Impurity 4 Hcl is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results against predefined specifications. We support compliance with ICH guidelines and relevant pharmacopeial standards for impurity standards.

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 desiccated environment to maintain stability and purity. Handle and store under an inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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