Description

The Metabolite Of Ivabradine is a key pharmacologically active compound derived from the metabolism of the cardiovascular drug Ivabradine. This metabolite is of significant interest for pharmaceutical research and development, particularly in the study of drug efficacy, pharmacokinetics, and safety profiles. It serves as a critical reference standard and intermediate for analytical laboratories, regulatory bodies, and manufacturers engaged in the development and quality control of heart rate-lowering medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Ivabradine and its metabolites in biological matrices and pharmaceutical formulations.
• Metabolite Identification & Pharmacokinetic Studies: Essential for ADME (Absorption, Distribution, Metabolism, Excretion) studies to understand the metabolic pathways and clearance rates of Ivabradine.
• Bioanalytical Method Development & Validation: Serves as a critical standard in developing and validating HPLC, LC-MS, and other chromatographic methods for therapeutic drug monitoring.
• Impurity Profiling & Drug Safety Assessment: Used to identify, characterize, and quantify metabolic impurities in active pharmaceutical ingredient (API) batches to ensure drug safety and compliance with ICH guidelines.
• Clinical Research & Toxicology: Employed in clinical trials and toxicological studies to correlate metabolite levels with drug efficacy and potential side effects.
• Regulatory Submission & Compliance: Provides necessary data for regulatory filings with agencies like the FDA and EMA to demonstrate thorough understanding of a drug's metabolic fate.

Basic Information

Product Name	The Metabolite Of Ivabradine
CAS No.	215935-23-2
Molecular Formula	C27H36N2O5
Molecular Weight	468.59 g/mol
Synonyms	N-Desmethyl Ivabradine Metabolite; S 18982-1; (3aR,7aS)-2-[(7S)-3,4-Dimethoxy-7-bicyclo[4.2.0]octa-1,3,5-trien-7-yl]-3a,4,5,6,7,7a-hexahydro-2H-benzimidazol-2-one; Ivabradine Metabolite; Ivabradine Related Compound; S-18982-1; 7,8-Dimethoxy-3-(7-oxa-3-azabicyclo[4.2.0]octa-1,3,5-trien-7-yl)-1,2,3,4-tetrahydroisoquinoline Derivative
EINECS	Contact for details

Quality Control

Our The Metabolite Of Ivabradine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical research and reference standards. Certificates of Analysis (COA) with detailed chromatographic data are provided to guarantee traceability, consistency, and reliability for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. For long-term storage, consider storing desiccated at -20°C. Handle the material in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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