Description

Dapoxetine Impurities395 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Dapoxetine. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and quality control departments for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Dapoxetine API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC labs to monitor impurity levels against strict pharmacopeial limits (e.g., ICH Q3A/B).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used to track the formation of degradation products in Dapoxetine formulations under various stress conditions (heat, light, humidity).
• Research & Development (R&D): Supports synthetic chemistry research, including route scouting and process optimization to minimize impurity formation.

Basic Information

Product Name	Dapoxetine Impurities395
CAS No.	2415108-76-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapoxetine Related Compound 395; Dapoxetine Impurity 395; Dapoxetine EP Impurity 395; Dapoxetine USP Impurity 395; Dapoxetine Process Impurity; Dapoxetine Degradant; (S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine Impurity (specific isomer); Priligy Impurity
EINECS	Contact for details

Quality Control

Our Dapoxetine Impurities395 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods for structural verification (NMR, MS). We provide comprehensive Certificates of Analysis (COA) that detail batch-specific results, ensuring traceability and compliance with ICH guidelines and relevant pharmacopeial standards. Our quality commitment supports your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a cool, dry place. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed and stored in a desiccated environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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