Description

(-)-(S)-Cibenzoline is the single enantiomer of the class I antiarrhythmic agent cibenzoline, characterized by its high stereochemical purity. This specific chiral form is of significant value in pharmaceutical research and development for studying stereospecific biological activity and pharmacokinetics. It is primarily utilized by research institutions and pharmaceutical companies engaged in advanced cardiovascular drug discovery, process development, and analytical method validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification, assay, and impurity profiling of cibenzoline in drug substances and products.
• Cardiovascular Research: Used as a key chiral intermediate or active pharmacological ingredient (API) in preclinical studies targeting cardiac sodium channels.
• Metabolism and Pharmacokinetics (DMPK): Employed in studies to investigate the enantioselective absorption, distribution, metabolism, and excretion (ADME) properties of cibenzoline.
• Analytical Method Development: Critical for developing and validating stereospecific analytical methods, such as chiral HPLC or CE, for quality control.
• Process Chemistry: Used as a benchmark in the development and optimization of asymmetric synthesis routes for chiral drug molecules.
• Regulatory Submissions: Provides essential data and materials for regulatory filings requiring characterization of the specific enantiomer used in a drug formulation.

Basic Information

Product Name	(-)-(S)-Cibenzoline
CAS No.	103419-18-7
Molecular Formula	C18H20N2
Molecular Weight	264.37 g/mol
Synonyms	(S)-Cibenzoline; (-)-Cibenzoline; (S)-2-(2,2-Diphenylcyclopropyl)-4,5-dihydro-1H-imidazole; Cibenol; Cipralan; Exacor; (S)-1-(2,2-Diphenylcyclopropyl)-2-imidazoline; UP 339-01
EINECS	Contact for details

Quality Control

Our (-)-(S)-Cibenzoline is produced under strict quality management systems to ensure batch-to-batch consistency and high chemical purity. Each lot is accompanied by a comprehensive Certificate of Analysis (COA) detailing key parameters such as chiral purity, chemical assay, and impurity profiles. We support compliance with cGMP and ICH guidelines for pharmaceutical ingredients, making this material suitable for demanding research and development applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Chiral Purity (Chiral HPLC)	≥99.0% (S-enantiomer)
Loss on Drying	≤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.