Description

Flibanserin Hydrochloride is a high-purity pharmaceutical active ingredient (API) with the CAS registry number 147359-76-0. This compound is a critical intermediate and final active substance in the development and manufacturing of specialized central nervous system (CNS) therapeutics. It is primarily required by pharmaceutical R&D laboratories, contract manufacturing organizations (CMOs), and finished dosage form producers engaged in advanced therapeutic areas.

Application

• Pharmaceutical API Synthesis: Primary active ingredient for the formulation of specific CNS-targeting medications.
• Clinical Research & Development: Serves as a key reference standard and raw material in preclinical and clinical trial studies.
• Regulatory Submission Batches: Used to manufacture validation and registration batches required for regulatory filings (e.g., with FDA, EMA).
• Analytical Method Development: Acts as a high-purity standard for developing and validating HPLC, LC-MS, and other analytical methods.
• Contract Pharmaceutical Manufacturing: Supplied to CMOs for the commercial-scale production of finished dosage forms.
• Academic & Biomedical Research: Utilized in university and institutional research to study receptor interactions and pharmacological profiles.

Basic Information

Product Name	Flibanserin Hydrochloride
CAS No.	147359-76-0
Molecular Formula	C₂₀H₂₂ClFN₄O • HCl
Molecular Weight	441.33 g/mol (as hydrochloride salt)
Synonyms	Flibanserin HCl; 1,3-Dihydro-1-[2-[4-[3-(trifluoromethyl)phenyl]-1-piperazinyl]ethyl]-2H-benzimidazol-2-one hydrochloride; BIMT 17 hydrochloride; BIMT-17 BS hydrochloride; Addyi (brand name, as finished product); BIMT 17 BS
EINECS	Contact for details

Quality Control

Our Flibanserin Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A detailed Certificate of Analysis (COA) providing results for assay, related substances, residual solvents, and other critical parameters is supplied with every shipment to guarantee traceability and compliance.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details

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