Description

Dapoxetine Impurity CAS NO 38262-42-9 is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity profile marker for the active pharmaceutical ingredient Dapoxetine, which is used in the treatment of premature ejaculation. It is essential for analytical method development, validation, and ensuring the quality, safety, and regulatory compliance of the final drug product. Pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories require this standard to meet stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material to identify and quantify related substances in Dapoxetine API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and GC methods to ensure specificity, accuracy, and precision.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure product consistency against ICH Q3A/B guidelines.
• Regulatory Compliance & Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Facilitates process chemistry optimization by helping to identify and control synthetic impurities.

Basic Information

Product Name	Dapoxetine Impurity
CAS No.	38262-42-9
Molecular Formula	C21H23NO
Molecular Weight	305.41 g/mol
Synonyms	(3S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine; Dapoxetine Related Compound; Dapoxetine EP Impurity; Dapoxetine USP Impurity; 1-Phenyl-3-(1-naphthyloxy)propyl dimethylamine; (S)-N,N-Dimethyl-3-(1-naphthyloxy)-1-phenylpropylamine; Dapoxetine Process Impurity
EINECS	Contact for details

Quality Control

Our Dapoxetine Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and control of residual solvents and heavy metals, to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results and confirming traceability to primary reference standards.

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 product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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