Description

n-Desmethyl Ivabradine D6 HCl is a high-purity, deuterium-labeled internal standard critical for precise bioanalytical quantification. This compound is essential for ensuring accuracy and reliability in pharmacokinetic and metabolism studies, particularly for the parent drug Ivabradine. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development and regulatory compliance work.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard in LC-MS/MS and GC-MS methods for the accurate measurement of Ivabradine and its metabolites in biological matrices (plasma, serum, urine).
• Pharmacokinetic (PK) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Metabolite Profiling & Identification: Aids in the structural elucidation and quantification of Ivabradine metabolites during drug metabolism studies.
• Method Development & Validation: Used as a reference standard to develop, optimize, and validate robust analytical methods compliant with GLP and ICH guidelines.
• Quality Control in Manufacturing: Supports impurity profiling and assay verification of Ivabradine active pharmaceutical ingredient (API) and finished dosage forms.

Basic Information

Product Name	n-Desmethyl Ivabradine D6 HCl
CAS No.	1346600-74-5
Molecular Formula	C26H37D6N3O5 • HCl
Molecular Weight	Contact for details
Synonyms	N-Desmethyl Ivabradine-d6 Hydrochloride; Ivabradine N-Desmethyl-d6 HCl; 3-({(7S)-3,4-Dimethoxy-7,8,9,10,11,12-hexahydro-7H-cycloocta[b]pyridin-7-yl}methyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one N-Desmethyl-d6 Hydrochloride; S 16260-2 N-Desmethyl-d6 HCl; Deuterated n-Desmethyl Ivabradine HCl; Ivabradine Metabolite D6 Standard.
EINECS	Contact for details

Quality Control

Our n-Desmethyl Ivabradine D6 HCl is manufactured under strict quality systems to ensure the high purity and isotopic enrichment required for analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, isotopic purity (D-enrichment), and identity confirmation via advanced spectroscopic techniques. We adhere to standards relevant to reference materials and analytical standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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