Description

Ivabradine Impurity 15 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of Ivabradine hydrochloride, a key cardiovascular medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Ivabradine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurities during the drug manufacturing process.
• Quality Control & Batch Release: A critical component in routine QC testing to ensure drug substance and drug product batches meet stringent pharmacopeial (e.g., USP, EP) and ICH regulatory specifications.
• Stability Studies: Employed to track the formation of degradation products in Ivabradine formulations under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) to health authorities like the FDA and EMA.
• Research & Development: Used in R&D laboratories to study the degradation pathways and impurity profiles of Ivabradine.

Basic Information

Product Name	Ivabradine Impurity 15
CAS No.	1552361-50-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ivabradine Related Compound 15; Ivabradine Impurity; 7,8-Dimethoxy-3-{[(7S)-3,4-dimethoxy-7,8,9,10-tetrahydro-6H-cyclohepta[b]quinolin-10-yl]methyl}-1,3,4,5-tetrahydro-2H-3-benzazepin-2-one (IUPAC-based); Ivabradine Process Impurity; S 16257 Impurity; Coralan Impurity; Procoralan Impurity
EINECS	Contact for details

Quality Control

Our Ivabradine Impurity 15 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, MS, and NMR. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment and handled to minimize exposure to moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.