Description

Dapoxetine Impurity CAS NO 2242008-38-2 is a high-purity chemical reference standard used in the analytical profiling and quality control of Dapoxetine Active Pharmaceutical Ingredient (API). This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in method development, validation, and stability studies for the production of Dapoxetine-based pharmaceuticals.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Dapoxetine API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to confirm that Dapoxetine products meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination and packaging decisions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Development (R&D): Aids in process chemistry research to understand and minimize impurity formation during the synthetic pathway of Dapoxetine.

Basic Information

Product Name	Dapoxetine Impurity
CAS No.	2242008-38-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapoxetine Related Compound; Dapoxetine Process Impurity; Dapoxetine Degradant; (S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine Impurity; Dapoxetine Specified Impurity; Priligy Impurity; 2242008-38-2; Dapoxetine Analog
EINECS	Contact for details

Quality Control

Every batch of Dapoxetine Impurity (CAS 2242008-38-2) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 in a desiccated environment to maintain stability and purity. Handle and store under an inert atmosphere if specified for long-term storage.

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 ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.