Description

Ivabradine Impurity 68 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of Ivabradine HCl, a key cardiovascular drug, by serving as a benchmark in quality control testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Ivabradine HCl active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug substance and product meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity profiles.
• Stability Studies: Used to track the formation of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Research & Development: Supports synthetic route optimization and degradation pathway studies during the drug development process.

Basic Information

Product Name	Ivabradine Impurity 68
CAS No.	1220993-44-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ivabradine Related Compound 68; Ivabradine EP Impurity I; Ivabradine USP Impurity; (7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-amine (related to Ivabradine synthesis); S 16257 Impurity; Procoralan Impurity; Coralan Impurity; Corlentor Impurity
EINECS	Contact for details

Quality Control

Our Ivabradine Impurity 68 is manufactured and tested under strict quality systems. Each batch undergoes rigorous analytical characterization using advanced techniques like HPLC, GC, MS, and NMR to confirm identity and purity, ensuring compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for all critical parameters.

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 kept under inert conditions or in a desiccator to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
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.