Description

Dapoxetine Impurity 2 is a designated impurity standard of the active pharmaceutical ingredient Dapoxetine Hydrochloride, a medication used for the treatment of premature ejaculation. This high-purity reference material is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Dapoxetine Impurity 2 in Dapoxetine Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Used to develop and optimize chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing protocols.
• Research & Development: Used in pharmaceutical R&D for studying degradation pathways and synthesis process optimization to minimize impurity formation.

Basic Information

Product Name	Dapoxetine Impurity 2
CAS No.	156453-51-9
Molecular Formula	C21H23NO
Molecular Weight	305.41 g/mol
Synonyms	(3S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine; Dapoxetine EP Impurity B; Dapoxetine Related Compound B; Dapoxetine N-Oxide Impurity; 1-Phenyl-3-[(1S)-1-(naphthalen-1-yloxy)]-N,N-dimethylpropylamine; Priligy Impurity B; LY 210448 Impurity
EINECS	Contact for details

Quality Control

Our Dapoxetine Impurity 2 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation, identity verification by IR and MS, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards align with ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15°C and 25°C (59°F and 77°F). The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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