Description

(-)-4-(4-Dimethylamino)-1-(4-Fluorophenyl)-1-(Hydroxybuty)-3-Hydroxymethyl)-Benzonitrile Hemi D-(+)-Di-p-Toloyltartaric Acid Salt CAS NO 128173-53-5 is a high-purity chiral intermediate and salt form, specifically designed for advanced pharmaceutical synthesis. This compound is critical for ensuring the stereochemical purity and bioavailability of active pharmaceutical ingredients (APIs), particularly in the development of central nervous system (CNS) and cardiovascular therapeutics. It is an essential building block for research institutions and manufacturers specializing in enantiomerically pure drug substances, where precise molecular configuration is paramount for efficacy and safety.

Application

• Pharmaceutical Intermediate: A key chiral precursor in the synthesis of enantiomerically pure Active Pharmaceutical Ingredients (APIs).
• Asymmetric Synthesis: Used in catalytic and stoichiometric asymmetric reactions to introduce specific stereocenters.
• Neurological & Psychiatric Drug Development: Serves as a critical building block for compounds targeting serotonin and dopamine receptors.
• Cardiovascular Drug Research: Employed in the development of β-blockers and other cardiovascular agents requiring specific stereochemistry.
• Process Chemistry & Scale-Up: Utilized in process research and development (PR&D) and pilot-scale manufacturing for new chemical entities (NCEs).
• Reference Standard: Acts as a high-purity analytical standard for quality control and regulatory submissions.

Basic Information

Product Name	(-)-4-(4-Dimethylamino)-1-(4-Fluorophenyl)-1-(Hydroxybuty)-3-Hydroxymethyl)-Benzonitrile Hemi D-(+)-Di-p-Toloyltartaric Acid Salt
CAS No.	128173-53-5
Molecular Formula	C41H44FN3O8
Molecular Weight	725.81 g/mol
Synonyms	Duloxetine Impurity; Duloxetine Related Compound; (S)-Duloxetine Ditoloyl Tartrate Salt; (-)-Duloxetine Ditoloyl Tartrate; (S)-N-Methyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propanamine Ditoloyl Tartrate; LY248686 Hemi D-(+)-Di-p-Toloyltartaric Acid Salt; (S)-Duloxetine Hemi-Di-p-Toluoyltartrate; Duloxetine Intermediate Salt
EINECS	Contact for details

Quality Control

Our (-)-4-(4-Dimethylamino)-1-(4-Fluorophenyl)-1-(Hydroxybuty)-3-Hydroxymethyl)-Benzonitrile Hemi D-(+)-Di-p-Toloyltartaric Acid Salt is manufactured under strict quality management systems to ensure batch-to-batch consistency and high purity. Each lot is accompanied by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles. We support compliance with ICH guidelines and can provide material suitable for use in GMP-regulated environments upon request.

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 compound is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Specific Rotation	[α]20/D: Contact for details
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 1.5%; Any single impurity ≤ 0.5%

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