Description

Ivabradine Impurity 1 Hydrochloride is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities during the manufacturing and quality assurance of Ivabradine, a cardiovascular drug. It is primarily used by analytical laboratories, quality control units, and regulatory affairs departments within the global pharmaceutical and biotechnology industries to ensure product safety, efficacy, and compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Ivabradine API and finished dosage forms.
• Analytical Research: Used in HPLC, LC-MS, and other chromatographic techniques for impurity profiling, stability studies, and degradation pathway analysis.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data to meet ICH Q3A(R2) and Q3B(R2) guidelines for drug substance and product impurities.
• Process Chemistry: Aids in the optimization of synthetic routes by monitoring and controlling the formation of this specific impurity during Ivabradine manufacturing.
• Pharmacopoeial Testing: Employed as a system suitability and identification standard in compliance with pharmacopoeial monographs (e.g., USP, EP).

Basic Information

Product Name	Ivabradine Impurity 1 Hydrochloride
CAS No.	85175-52-6
Molecular Formula	C27H37N2O5 • HCl
Molecular Weight	521.06 g/mol
Synonyms	3-({(7S)-3,4-Dimethoxy-7,8,9,10-tetrahydro-6,9-methano[1,2]azacycloundecino[5,4-b]indol-7(6H)-yl}methyl)-1-methyl-1H-indole-6-carbonitrile Hydrochloride; Ivabradine Related Compound 1 HCl; S 16260-1 Hydrochloride; Ivabradine Impurity A HCl; (7S)-7-{[6-Cyano-1-methyl-1H-indol-3-yl]methyl}-3,4-dimethoxy-7,8,9,10-tetrahydro-6,9-methano[1,2]azacycloundecino[5,4-b]indole Hydrochloride
EINECS	Contact for details

Quality Control

Our Ivabradine Impurity 1 Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatograms and spectra where applicable, is provided with every shipment to support your regulatory and quality needs.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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