Description

Dapoxetineimpurity26Hcl is a high-purity chemical reference standard, specifically identified as an impurity of the pharmaceutical compound Dapoxetine. This material is critical for analytical research and development, providing a benchmark for the identification, qualification, and control of related substances in active pharmaceutical ingredients (APIs). It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of process-related impurities in Dapoxetine HCl API batches.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure API purity meets regulatory specifications.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Dapoxetine.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the manufacturing process.
• Research and Development: Used in chemical research to study the synthesis, properties, and behavior of Dapoxetine-related compounds.

Basic Information

Product Name	Dapoxetineimpurity26Hcl
CAS No.	2414049-30-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dapoxetine Impurity 26 Hydrochloride; Dapoxetine Related Compound 26 HCl; Dapoxetine EP Impurity 26 HCl; Dapoxetine USP Impurity 26 Hydrochloride; Dapoxetine HCl Impurity 26; (S)-Dapoxetine Impurity 26 Hydrochloride; Priligy Impurity 26 HCl
EINECS	Contact for details

Quality Control

Our Dapoxetineimpurity26Hcl is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed test results, ensuring full traceability and compliance with current industry and regulatory expectations for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature (typically 15-25°C) in a dry environment. The material should be handled with care to prevent contamination and moisture uptake.

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)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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