Description

Ivabradine Impurity 5 is a high-purity reference standard used in the pharmaceutical development and quality control of Ivabradine HCl, a selective sinus node inhibitor. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control of process-related impurities. It is an essential material for analytical method development, validation, and regulatory compliance in pharmaceutical R&D and manufacturing. Quality-focused laboratories and manufacturers in the global pharmaceutical and contract research sectors require this standard to meet stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Ivabradine-related impurities.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Used to monitor the formation and levels of this specific impurity in Ivabradine drug substance and product under various storage conditions.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Ivabradine to minimize impurity formation.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability and calibration standard in routine batch release testing.

Basic Information

Product Name	Ivabradine Impurity 5
CAS No.	1870894-09-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ivabradine Related Compound 5; Ivabradine Impurity C; (7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-amine; S 16257 Impurity; Procoralan Impurity; Coralan Impurity; Corlentor Impurity
EINECS	Contact for details

Quality Control

Every batch of Ivabradine Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your regulatory and research 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. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
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 individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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