Description

Duloxetine Impurity CAS NO 494221-37-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) duloxetine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for maintaining the stringent standards of modern pharmaceutical production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in duloxetine hydrochloride API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine batch release testing to ensure duloxetine products meet pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products in duloxetine formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Supports process chemistry research to understand and minimize impurity formation during duloxetine synthesis.

Basic Information

Product Name	Duloxetine Impurity
CAS No.	494221-37-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Duloxetine Related Compound; Duloxetine Process Impurity; (S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine Impurity; Duloxetine EP Impurity; Duloxetine USP Impurity; 1-Naphthalenol, 3-(methylamino)-1-(2-thienyl)propyl ether, (αS)-; LY248686 Impurity
EINECS	Contact for details

Quality Control

Every batch of Duloxetine Impurity (CAS 494221-37-3) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing the results for assay, related substances, residual solvents, and other critical parameters is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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