Description

Dapoxetine Impurity 24 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 pharmaceutical products containing Dapoxetine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The product is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Dapoxetine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control.
• Stability Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability testing of Dapoxetine products.
• Research & Development: Used in R&D to study the degradation pathways, synthesis pathways, and chemical behavior of Dapoxetine and related compounds.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine batch release testing to ensure product purity and specification adherence.

Basic Information

Item	Details
Product Name	Dapoxetine Impurity 24
CAS No.	1445281-20-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapoxetine Related Compound 24; Dapoxetine EP Impurity 24; Dapoxetine USP Impurity 24; Dapoxetine Process Impurity; (S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine Impurity; Dapoxetine Nitroso Impurity; Dapoxetine Nitrosamine Impurity; Dapoxetine N-Nitroso Impurity
EINECS	Contact for details

Quality Control

Every batch of Dapoxetine Impurity 24 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity.

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 guidelines
Water Content (KF)	≤ 5.0%

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