Description

Dapoxetine Impurity 5 is a designated impurity standard used in the analytical profiling and quality control of Dapoxetine, an active pharmaceutical ingredient. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations. It is primarily required by analytical laboratories, quality assurance departments, and research institutions involved in the development and manufacturing of pharmaceuticals.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Dapoxetine API and finished dosage forms.
• Essential for method development and validation in analytical techniques such as HPLC and LC-MS.
• Critical component in stability studies to monitor impurity profiles over the shelf life of pharmaceutical products.
• Used for regulatory compliance and submission to agencies like the FDA and EMA, supporting CMC (Chemistry, Manufacturing, and Controls) documentation.
• Serves as a key reagent in pharmaceutical research to understand degradation pathways and synthesis by-products.
• Supports quality control laboratories in establishing specification limits and release testing protocols.

Basic Information

Product Name	Dapoxetine Impurity 5
CAS No.	1181810-25-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapoxetine Related Compound 5; Dapoxetine EP Impurity 5; Dapoxetine USP Impurity 5; Dapoxetine Process Impurity; (S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine Impurity; Dapoxetine Degradant
EINECS	Contact for details

Quality Control

Our Dapoxetine Impurity 5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and other critical parameters. We support compliance with ICH guidelines and pharmacopeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term stability, consider storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference retention time
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% 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.