Description

Dapoxetine Impurity CAS NO 94305-25-6 is a high-purity chemical reference standard used in the analytical profiling and quality control of Dapoxetine, an active pharmaceutical ingredient (API). This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Primary use as a pharmaceutical reference standard for Dapoxetine API quality control.
• Critical component in analytical method development and validation (HPLC, UPLC, GC).
• Used for impurity identification and characterization studies in regulatory filings (e.g., ICH guidelines).
• Essential for stability studies and degradation pathway elucidation of Dapoxetine formulations.
• Serves as a calibration standard in quantitative impurity analysis.
• Supports research and development (R&D) in process chemistry for impurity control and minimization.
• Utilized by contract research organizations (CROs) and quality assurance (QA) laboratories.

Basic Information

Product Name	Dapoxetine Impurity
CAS No.	94305-25-6
Molecular Formula	C21H23NO
Molecular Weight	305.41 g/mol
Synonyms	(3S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine; Dapoxetine Related Compound; Dapoxetine Process Impurity; 1-Phenyl-3-[(1S)-1-(1-naphthalenyloxy)propyl]-N,N-dimethyl-1-propanamine; (S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine; Priligy Impurity; LY 210448 Impurity
EINECS	Contact for details

Quality Control

Our Dapoxetine Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and specifications.

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 must be kept under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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