Description

Ivabradine Impurity 49 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Ivabradine, a medication used to treat chronic heart failure and angina pectoris. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and ensuring drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ivabradine Impurity 49 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor this specific impurity.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in in-house quality control laboratories to ensure Ivabradine batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and demonstrate control strategies.
• Stability Studies: Employed in forced degradation and long-term stability studies of Ivabradine to track the formation and levels of this impurity over time.
• Research & Development: Used in synthetic chemistry R&D to study impurity formation pathways and optimize purification processes.

Basic Information

Product Name	Ivabradine Impurity 49
CAS No.	2387117-59-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ivabradine Related Compound 49; Ivabradine EP Impurity I; Ivabradine USP Impurity; (7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-amine (related to Ivabradine); Procoralan Impurity 49; Coralan Impurity 49; S 16257 Impurity; Ivabradine Process Impurity
EINECS	Contact for details

Quality Control

Our Ivabradine Impurity 49 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
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%

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