Description

Dapoxetine Impurity 13 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Dapoxetine. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker for identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of Dapoxetine-based products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Dapoxetine Impurity 13 in API and finished drug products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control impurity levels to comply with ICH guidelines and pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Dapoxetine.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization.
• Research and Development: Supports synthetic route optimization and process chemistry research by identifying and controlling process-related impurities.

Basic Information

Product Name	Dapoxetine Impurity 13
CAS No.	156453-50-8
Molecular Formula	C21H23NO
Molecular Weight	305.41 g/mol
Synonyms	Dapoxetine Related Compound 13; Dapoxetine EP Impurity 13; Dapoxetine USP Impurity 13; (3S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine; 1-Phenyl-3-[(1S)-1-(naphthalen-1-yloxy)propyl]dimethylamine; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Our Dapoxetine Impurity 13 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with current pharmacopeial expectations (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and other critical parameters.

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 conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified 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.