Description

Ivabradine Impurity (Br) CAS NO 1428869-91-3 is a brominated derivative used as a critical reference standard and impurity in the pharmaceutical development and quality control of Ivabradine hydrochloride. This compound is essential for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by enabling accurate identification and quantification of process-related impurities. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, method validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods in QC/QA labs.
• Impurity Profiling & Characterization: Critical for identifying, monitoring, and controlling the specified impurity during Ivabradine API synthesis and purification processes.
• Method Development & Validation: Serves as a key component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity levels in drug substances and products over time.
• Research & Development: Used in synthetic chemistry research to study metabolic pathways, degradation mechanisms, and to synthesize related analogs.

Basic Information

Product Name	Ivabradine Impurity (Br)
CAS No.	1428869-91-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ivabradine Bromo Impurity; Ivabradine Related Compound Br; 3-({(7S)-3,4-Dimethoxy-7,8,9,10-tetrahydro-6,9-methano[1,2]azaborino[5,4-e]pyridin-7-yl}methyl)-1-bromo-6,7-dimethoxyisoquinoline; (7S)-7-{[1-Bromo-6,7-dimethoxy-3-isoquinolyl]methyl}-3,4-dimethoxy-7,8,9,10-tetrahydro-6,9-methano[1,2]azaborino[5,4-e]pyridine; Ivabradine Impurity 4 (Br); Ivabradine Brominated Impurity
EINECS	Contact for details

Quality Control

Our Ivabradine Impurity (Br) is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and structural confirmation (NMR, MS), to ensure it meets the high standards required for pharmaceutical impurity standards. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 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.