Description

Dapoxetine Impurity 15 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of Dapoxetine hydrochloride, an active pharmaceutical ingredient (API). It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance. The precise characterization of this impurity is essential for meeting stringent pharmacopeial and regulatory requirements.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Dapoxetine API.
• Critical component in analytical method development and validation (e.g., HPLC, LC-MS) for Dapoxetine formulations.
• Essential for stability studies and degradation pathway profiling of Dapoxetine drug products.
• Used in quality control (QC) and quality assurance (QA) laboratories to monitor batch-to-batch consistency.
• Serves as a key material for regulatory submissions (e.g., ANDA, CTA) to demonstrate comprehensive impurity control.
• Valuable for pharmaceutical research into the synthesis and metabolism of Dapoxetine.

Basic Information

Product Name	Dapoxetine Impurity 15
CAS No.	2249892-52-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapoxetine Related Compound 15; Dapoxetine EP Impurity J; Dapoxetine USP Impurity; Dapoxetine Hydrochloride Impurity 15; (S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine Impurity; Priligy Impurity 15; Dapoxetine Process Impurity
EINECS	Contact for details

Quality Control

Our Dapoxetine Impurity 15 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles as determined by validated analytical methods (HPLC, NMR, MS). We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards (USP, EP). Certificates of Analysis are available upon request.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability. The container should be sealed under an inert atmosphere after each use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
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.