Description

Duloxetine Impurity 4 is a specified impurity associated with the active pharmaceutical ingredient (API) duloxetine hydrochloride. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of duloxetine-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in duloxetine API and finished dosage forms.
• Analytical Method Development: Crucial for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure duloxetine batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity characterization.
• Process Chemistry Research: Aids in understanding and optimizing the duloxetine synthesis pathway to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Duloxetine Impurity 4
CAS No.	1000386-62-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Duloxetine Related Compound 4; Duloxetine EP Impurity 4; Duloxetine USP Impurity 4; (S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine Impurity; A potential process-related impurity of Duloxetine Hydrochloride
EINECS	Contact for details

Quality Control

Our Duloxetine Impurity 4 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Quality is verified against relevant pharmacopeial standards and in-house specifications using advanced techniques like HPLC and mass spectrometry. A comprehensive Certificate of Analysis (COA), detailing identity, purity, and impurity profile, is provided with each batch to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle the material in accordance with good laboratory practices.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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