Description

Dapoxetine Impurity 11/(S)-n-Didemethyl Dapoxetine Hcl/(S)-α-[2-(1-Naphthalenyloxy)Ethyl]Benzenemethanamine Hydrochloride is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key specified impurity in the analytical profiling and quality control of Dapoxetine, an active pharmaceutical ingredient (API). It is essential for laboratories requiring precise identification, quantification, and monitoring of impurities to ensure drug safety, efficacy, and regulatory compliance. This standard is primarily used by pharmaceutical manufacturers, analytical testing laboratories, and regulatory affairs departments.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Dapoxetine Impurity 11 in API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Dapoxetine API meets stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to monitor the formation of this specific degradant under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Supports synthetic chemistry research, including route scouting and process optimization to minimize impurity formation.

Basic Information

Product Name	Dapoxetine Impurity 11/(S)-n-Didemethyl Dapoxetine Hcl/(S)-α-[2-(1-Naphthalenyloxy)Ethyl]Benzenemethanamine Hydrochloride
CAS No.	2095189-99-2
Molecular Formula	C19H20NO•ClH (or C19H21ClNO)
Molecular Weight	315.83 g/mol (for free base C19H20NO)
Synonyms	(S)-n-Didemethyl Dapoxetine Hydrochloride
(S)-α-[2-(1-Naphthalenyloxy)Ethyl]Benzenemethanamine Hydrochloride
Dapoxetine N-Desmethyl Impurity
Dapoxetine Related Compound H
(S)-1-Naphthalen-1-yloxy-3-phenylpropan-2-amine Hydrochloride (didemethyl derivative)
Dapoxetine Impurity F (in some literature)
Benzylamine, α-[2-(1-naphthalenyloxy)ethyl]-, (αS)-, hydrochloride
EINECS	Contact for details

Quality Control

Our Dapoxetine Impurity 11 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, LC-MS, NMR, and IR spectroscopy to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, impurities, and residual solvents. Our quality standards are designed to support compliance with ICH Q3A, Q3B, USP, and EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15°C to 25°C (59°F to 77°F). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	97.0% - 103.0%

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