Description

Dapoxetine Impurity 28 is a designated impurity standard used in the analytical profiling and quality control of Dapoxetine active pharmaceutical ingredient (API) and its related pharmaceutical formulations. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analyses. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and compliance testing of Dapoxetine-based treatments.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Dapoxetine Impurity 28 in API and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Critical for preparing impurity profiles and supporting documentation for regulatory filings (e.g., with FDA, EMA) for new drug applications (NDAs) and abbreviated new drug applications (ANDAs).
• Research and Development (R&D): Utilized in synthetic chemistry research to understand degradation pathways and to develop purification processes for the Dapoxetine API.

Basic Information

Item	Detail
Product Name	Dapoxetine Impurity 28
CAS No.	1445281-25-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapoxetine Related Compound 28; Dapoxetine EP Impurity 28; Dapoxetine USP Impurity 28; (S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine Impurity; Dapoxetine Degradation Product; Dapoxetine Process Impurity; Priligy Impurity 28
EINECS	Contact for details

Quality Control

Our Dapoxetine Impurity 28 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay results, and chromatographic data. Our quality commitment aligns with ICH guidelines and supports compliance with global regulatory expectations.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
Assay	95.0% - 105.0%
Residual Solvents (GC)	Complies with ICH Q3C

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