Description

Ivabradine Impurity CAS NO 1616710-50-9 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Ivabradine, a medication for chronic heart failure and angina pectoris. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify and quantify this specific impurity in Ivabradine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies of Ivabradine to understand degradation pathways and establish shelf-life.
• Quality Control and Batch Release: Essential for in-process testing and final quality control of Ivabradine batches to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B, USP, EP).
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research and Development: Used in synthetic chemistry research to study the formation and fate of this impurity during the manufacturing process of Ivabradine.

Basic Information

Product Name	Ivabradine Impurity
CAS No.	1616710-50-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ivabradine Related Compound; Ivabradine Process Impurity; Ivabradine Degradant; 3-({(7S)-3,4-Dimethoxy-7,8,9,10-tetrahydro-6,9-methano[1,2]azaborocino[5,6,7-cd]indol-7-yl}methyl)-1-methyl-1,3,8-triazaspiro[4.5]decane-2,4-dione; (7S)-7-{[2,4-Dioxo-1-methyl-1,3,8-triazaspiro[4.5]dec-3-yl]methyl}-N,N-dimethyl-6,9-methano-1,2,4-benzoxadiazaborocine-3-carboxamide 4-oxide; Ivabradine Impurity 1; Ivabradine Impurity A; Ivabradine Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Ivabradine Impurity CAS 1616710-50-9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with ICH guidelines and other relevant standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance 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 material is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 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.