Description

Ivabradine Impurity 15 is a designated impurity of the cardiovascular drug Ivabradine, identified by the CAS number 1132667-04-9. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Ivabradine-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ivabradine active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control & Assurance: Employed in routine QC testing to establish specification limits and ensure batch-to-batch consistency of Ivabradine.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Ivabradine.
• Research & Process Chemistry: Aids in synthetic route optimization by helping to identify and control the formation of this impurity during the manufacturing process.

Basic Information

Product Name	Ivabradine Impurity 15
CAS No.	1132667-04-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ivabradine Related Compound 15; Ivabradine EP Impurity J; Ivabradine USP Impurity; 3-({(7S)-3,4-Dimethoxy-7,8,9,10-tetrahydro-6,9-methanoazepino[4,5-b]indol-1(6H)-yl}methyl)-1-methyl-6,7-dimethoxyisoquinoline; Procoralan Impurity 15; Coralan Impurity 15; (7S)-1-[(1-Methyl-6,7-dimethoxy-3-isoquinolyl)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 15 is manufactured under strict quality systems suitable for pharmaceutical analysis. Each batch undergoes rigorous testing to ensure identity, purity, and consistency, aligning with current pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) is provided, detailing results from advanced chromatographic and spectroscopic analyses. We support regulatory needs with full traceability and documentation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). 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 (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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