Description

Dapoxetine Impurity CAS NO 2242008-37-1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical manufacturers and quality control laboratories to ensure the purity, safety, and efficacy of Dapoxetine API and its finished dosage forms. It serves as an essential tool for method development, validation, and regulatory compliance in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Dapoxetine Hydrochloride active pharmaceutical ingredient (API).
• Analytical Method Development: Used in developing and validating HPLC, UPLC, and GC methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Critical for routine batch release testing in pharmaceutical QC labs to monitor and control impurity levels.
• Regulatory Submissions: Supports the preparation of regulatory filings (e.g., DMF, CMC sections) by providing characterized impurity data for health authorities like the FDA and EMA.
• Stability Studies: Employed as a marker to track impurity formation during forced degradation and long-term stability studies of Dapoxetine formulations.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and metabolism of Dapoxetine.

Basic Information

Product Name	Dapoxetine Impurity
CAS No.	2242008-37-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapoxetine Related Compound; Dapoxetine Process Impurity; Dapoxetine Specified Impurity; (S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine Impurity; Dapoxetine Hydrochloride Impurity; Priligy Impurity; 2242008-37-1
EINECS	Contact for details

Quality Control

Our Dapoxetine Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established specifications. Our quality commitment aligns with cGMP principles and supports our clients' needs for regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
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.