Description

Ivabradine-D3 Hydrochloride is a deuterium-labeled isotopologue of the selective sinus node If channel inhibitor Ivabradine, used as a critical internal standard in quantitative bioanalytical methods. This high-purity reference material is essential for ensuring the accuracy and reliability of pharmacokinetic and metabolic studies, providing unmatched specificity for mass spectrometry analysis. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities engaged in advanced drug development and bioequivalence studies for cardiovascular therapeutics.

Application

• Internal Standard for LC-MS/MS: Serves as a stable, non-interfering internal standard for the precise quantification of Ivabradine and its metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic & Metabolism Studies: Enables accurate tracing of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Bioanalytical Method Development & Validation: Critical for developing, optimizing, and validating robust analytical methods compliant with FDA, EMA, and ICH guidelines.
• Drug Impurity Profiling & Degradation Studies: Used as a reference marker in stability-indicating methods to identify and quantify process-related impurities or degradation products.
• Clinical Trial Support: Supports bioanalytical work for Phase I-IV clinical trials, ensuring data integrity for regulatory submissions.
• Forensic & Doping Control Analysis: Applied in specialized testing for the accurate detection and confirmation of Ivabradine in forensic or anti-doping contexts.

Basic Information

Product Name	Ivabradine-D3 Hydrochloride
CAS No.	1217809-61-4
Molecular Formula	C27H33D3N2O5•HCl
Molecular Weight	505.07 g/mol (for monoisotopic mass)
Synonyms	3-({(7S)-3,4-Dimethoxy-7,8,9,10-tetrahydro-6,9-methano[1,2,4]triazolo[3,4-a]azepin-7(6H)-yl}methyl)-5-{[(2S)-6,6,6-trideuterio-5,5-dimethyl-2-morpholinyl]methyl}-1,3-oxazolidin-2-one hydrochloride; Ivabradine-d3 HCl; Ivabradine (methyl-d3) Hydrochloride; Procoralan-d3 Hydrochloride; Coralan-d3 Hydrochloride; Corlentor-d3 Hydrochloride; S 16257-d3 Hydrochloride
EINECS	Contact for details

Quality Control

Our Ivabradine-D3 Hydrochloride is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, assay, isotopic enrichment, and impurity profiles. We adhere to relevant industry standards for reference materials, and our quality commitment supports compliance with GMP, ICH Q7, and ISO 17034 guidelines for reference material producers. Certificates of Analysis are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to reference standard
Purity (HPLC)	≥98.0%
Isotopic Purity (deuterium, D3)	≥98.0 atom % D
Chemical Purity (NMR)	Conforms to structure
Water Content (KF)	≤2.0%
Residue on Ignition	≤0.5%

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