Description

7-Demethyl Ivabradine is a key pharmaceutical intermediate and reference standard in the synthesis of Ivabradine hydrochloride, a selective inhibitor of the cardiac pacemaker If current. This high-purity compound is critical for ensuring the quality, efficacy, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily utilized by research institutions, pharmaceutical development laboratories, and manufacturing facilities engaged in cardiovascular drug production and analytical method validation.

Application

• Pharmaceutical Intermediate: A crucial building block in the multi-step synthesis of Ivabradine HCl API.
• Reference Standard: Used for analytical method development, validation, and quality control (QC) testing of Ivabradine and related substances.
• Impurity Standard: Serves as a certified reference material (CRM) for identification and quantification of process-related impurities in Ivabradine batches.
• Research & Development: Employed in metabolic studies, pharmacokinetic research, and the development of novel derivatives or formulations.
• Regulatory Compliance: Essential for generating data to meet stringent regulatory filing requirements (e.g., FDA, EMA) for drug master files (DMFs).

Basic Information

Product Name	7-Demethyl Ivabradine
CAS No.	304462-60-0
Molecular Formula	C26H34N2O5
Molecular Weight	454.56 g/mol
Synonyms	7-Desmethyl Ivabradine; (3aR,7aR)-1,2,3,7a-Tetrahydro-7H-3a,6-epoxyisoindol-7-one, 3-[[7,8-dimethoxy-2,3,4,5-tetrahydro-1H-3-benzazepin-1-yl]methyl]-2,3,4,5-tetrahydro-; Ivabradine Impurity; Ivabradine Related Compound; S 16260-2; S-16260-2
EINECS	Contact for details

Quality Control

Our 7-Demethyl Ivabradine is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. We provide full traceability and detailed Certificates of Analysis (COA) that confirm compliance with in-house specifications tailored for pharmaceutical use. Our quality commitment supports your regulatory submissions and GMP requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage under inert atmosphere, please contact our technical team for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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