Description

Ivabradine Impurity 5 is a specified impurity and degradation product of the cardiovascular drug Ivabradine, used in pharmaceutical research and development. This compound is critical for analytical method validation, stability studies, and ensuring the quality and safety of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories involved in the production and regulatory compliance of Ivabradine-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ivabradine Impurity 5 in drug substances and products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor impurities in Ivabradine API and finished dosage forms.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of Ivabradine and to establish appropriate storage conditions and shelf-life.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to ensure impurity profiles meet ICH, USP, or EP guidelines.
• Regulatory Submissions: Provides necessary data on impurity characterization and control strategies for regulatory filings (e.g., with FDA, EMA).
• Research on Pharmacokinetics and Metabolism: Can be used in studies to trace the metabolic fate of Ivabradine and related compounds.

Basic Information

Product Name	Ivabradine Impurity 5
CAS No.	1462470-54-7
Molecular Formula	C27H36N2O5
Molecular Weight	468.59 g/mol
Synonyms	3-({(7S)-3,4-Dimethoxy-7,8,9,10-tetrahydro-6,9-methanoazepino[4,5-b]indol-7(6H)-yl}methyl)-5-methyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate; Ivabradine Related Compound 5; Ivabradine EP Impurity C; S 16260 Impurity; (7S)-7-({[3,5-Bis(methoxycarbonyl)-4-(3-nitrophenyl)-2,6-dimethyl-1,4-dihydropyridin-1-yl]methyl})-3,4-dimethoxy-7,8,9,10-tetrahydro-6,9-methanoazepino[4,5-b]indole
EINECS	Contact for details

Quality Control

Our Ivabradine Impurity 5 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and identity confirmation. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including HPLC purity, identity (IR, MS), and residual solvent analysis. The quality standards are designed to meet the requirements for use as a reference standard in pharmaceutical applications, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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