Description

Ivabradine Impurity 1 Hydrochloride is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the quality control and regulatory compliance of Ivabradine, a key cardiovascular medication. It is primarily used by analytical laboratories and pharmaceutical manufacturers for method validation, impurity profiling, and stability studies. Ensuring the integrity of your drug substance requires reliable and well-characterized impurity standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ivabradine Impurity 1 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Ivabradine API and formulations meet stringent pharmacopeial (e.g., USP, EP) purity specifications.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish drug shelf life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research and Development: Supports synthetic route optimization and impurity fate and tolerance studies during the development of Ivabradine.

Basic Information

Product Name	Ivabradine Impurity 1 Hydrochloride
CAS No.	85175-77-5
Molecular Formula	C27H37N2O5 • HCl
Molecular Weight	521.06 g/mol
Synonyms	3-({(7S)-3,4-Dimethoxy-7,8,9,10-tetrahydro-6,9-methanocycloocta[b]pyridin-7-yl}methyl)-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepin-8-ol Hydrochloride; Ivabradine Related Compound A Hydrochloride; S 16260-1 Hydrochloride; Ivabradine EP Impurity A HCl; Ivabradine USP Impurity A Hydrochloride; (7S)-7-{[8-Hydroxy-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepin-3-yl]methyl}-3,4-dimethoxy-7,8,9,10-tetrahydro-6,9-methanocycloocta[b]pyridine Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Ivabradine Impurity 1 Hydrochloride is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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