Description

(Rs)-Duloxetine Hydrochloride CAS NO 916135-70-1 is a key chiral intermediate and impurity reference standard used in the development and quality control of active pharmaceutical ingredients (APIs). This compound is of critical importance for ensuring the stereochemical purity and regulatory compliance of pharmaceutical products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the synthesis and analysis of serotonin-norepinephrine reuptake inhibitors (SNRIs).

Application

• Pharmaceutical impurity profiling and reference standard for duloxetine API quality control.
• Chiral intermediate in advanced pharmaceutical research and development (R&D).
• Critical material for method development and validation in analytical chemistry.
• Building block for the synthesis of novel chemical entities in medicinal chemistry.
• Used in stability studies to identify and quantify degradation products.
• Essential for regulatory submissions to agencies like the FDA and EMA.

Basic Information

Product Name	(Rs)-Duloxetine Hydrochloride
CAS No.	916135-70-1
Molecular Formula	C18H20ClNOS
Molecular Weight	333.87 g/mol
Synonyms	(±)-Duloxetine Hydrochloride; (RS)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine Hydrochloride; Duloxetine Racemate Hydrochloride; LY248686 Racemate Hydrochloride; Duloxetine Impurity; Duloxetine Related Compound; UNII-9044SC542W
EINECS	Contact for details

Quality Control

Our (Rs)-Duloxetine Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data (HPLC/GC) are provided and can be tailored to meet specific pharmacopeial (e.g., USP, EP) or internal specifications.

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 dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Individual unspecified impurity	≤ 0.5%
Optical Rotation	Contact for details
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Water Content (KF)	≤ 1.0%

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