Description

Flibanserin is a synthetic, non-hormonal pharmaceutical compound primarily known for its role as a serotonin receptor agonist and antagonist. This active pharmaceutical ingredient (API) is critical for the formulation of treatments targeting specific central nervous system conditions. It is essential for pharmaceutical manufacturers and research institutions engaged in the development of advanced therapeutic agents. The compound is supplied under stringent quality controls to ensure consistency and efficacy in end-use applications.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of prescription medications for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.
• Clinical Research: Serves as a key reference standard and investigational material in pharmacokinetic and pharmacodynamic studies.
• Drug Development: Utilized in preclinical and formulation research for developing novel dosage forms, including tablets and other oral delivery systems.
• Analytical Testing: Used as a high-purity standard in quality control laboratories for HPLC, LC-MS, and other chromatographic methods to assay finished drug products.
• Regulatory Submissions: Provides the necessary certified material for compiling documentation for regulatory agencies like the FDA and EMA.

Basic Information

Product Name	Flibanserin
CAS No.	167933-07-5
Molecular Formula	C20H21F3N4O
Molecular Weight	390.40 g/mol
Synonyms	BIMT 17; BIMT-17BS; BIMT 17 BS; 1-[2-(4-(3-Trifluoromethylphenyl)piperazin-1-yl)ethyl]-2,3-dihydro-1H-benzimidazol-2-one; 2H-Benzimidazol-2-one, 1,3-dihydro-1-[2-[4-[3-(trifluoromethyl)phenyl]-1-piperazinyl]ethyl]-
EINECS	Contact for details

Quality Control

Our Flibanserin is manufactured and tested under a quality management system aligned with current Good Manufacturing Practices (cGMP). Every batch undergoes comprehensive analytical testing, including identification, assay, and impurity profiling, to ensure it meets stringent pharmacopeial standards. A Certificate of Analysis (COA) detailing purity, related substances, residual solvents, and other critical parameters is provided with each shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The container should be kept in a well-ventilated area and protected from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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