Description

Ent-Ivabradine Hydrochloride is a high-purity enantiomer of the selective sinus node If channel inhibitor Ivabradine. This compound is a critical chiral intermediate and reference standard in pharmaceutical research and development. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in cardiovascular drug discovery, analytical method development, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification, assay, and impurity testing of Ivabradine and its related substances in accordance with pharmacopeial methods (e.g., USP, EP).
• Chiral Intermediate: Serves as a key building block in the enantioselective synthesis of active pharmaceutical ingredients (APIs) targeting heart rate reduction.
• Metabolite & Impurity Studies: Essential for the synthesis and characterization of drug metabolites and process-related impurities to fulfill regulatory requirements for drug submissions.
• Analytical Method Development: Employed in HPLC, LC-MS, and chiral separation method development to ensure accurate quantification and purity assessment.
• Preclinical & Clinical Research: Used in pharmacological studies to investigate the specific effects of the enantiomer, supporting structure-activity relationship (SAR) studies.
• Quality Control Laboratories: Acts as a system suitability standard and for routine quality control testing of bulk Ivabradine API batches.

Basic Information

Product Name	Ent-Ivabradine Hydrochloride
CAS No.	167072-91-5
Molecular Formula	C27H37N2O5•HCl
Molecular Weight	505.06 g/mol
Synonyms	(-)-Ivabradine Hydrochloride; (3R,4S)-Ivabradine Hydrochloride; S-16257-2; (3R,4S)-3-({[(7S)-3,4-dimethoxy-7,8,9,10-tetrahydro-6,7,10,11-tetrahydro-5H-cycloocta[b]quinolin-9-yl]oxy}methyl)-1-methylpiperidin-4-yl benzoate hydrochloride; Procoralan Impurity; Ivabradine Related Compound; Ivabradine Enantiomer HCl
EINECS	Contact for details

Quality Control

Our Ent-Ivabradine Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral purity verification by HPLC, to ensure it meets stringent specifications for pharmaceutical research. A detailed Certificate of Analysis (COA) providing batch-specific data for identity, purity, and related substances is supplied with every order.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	≥98.0%
Chiral Purity (Enantiomeric Excess)	≥99.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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