Description

Dapoxetine Impurities396 is a high-purity reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of pharmaceutical products containing Dapoxetine. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions to ensure product safety, efficacy, and to meet stringent regulatory requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Dapoxetine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods such as HPLC and UPLC in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Dapoxetine formulations under various stress conditions.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing impurity profiles as required by ICH guidelines Q3A and Q3B.
• Research & Development: Serves as a key intermediate or impurity marker in the synthetic pathway research and process optimization for Dapoxetine.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing to ensure impurity levels are within specified limits.

Basic Information

Product Name	Dapoxetine Impurities396
CAS No.	2415108-74-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapoxetine Related Compound 396; Dapoxetine Impurity 396; Dapoxetine EP Impurity 396; Dapoxetine USP Impurity 396; Dapoxetine Process Impurity; Dapoxetine Degradant; (S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine Impurity (specific isomer); Dapoxetine Analog
EINECS	Contact for details

Quality Control

Every batch of Dapoxetine Impurities396 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using advanced techniques like HPLC, GC-MS, and NMR to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere if specified.

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)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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