Description

Varenicline-D4 is a high-purity, deuterium-labeled internal standard essential for accurate quantitative analysis in advanced research and development. This stable isotope-labeled compound is critical for ensuring precision and reliability in mass spectrometry-based methods, particularly in pharmacokinetic and metabolic studies. It is primarily utilized by analytical laboratories and pharmaceutical R&D teams working on smoking cessation therapies and related neurological pathways.

Application

• Used as a deuterated internal standard for the precise quantification of Varenicline in biological matrices via LC-MS/MS and GC-MS.
• Critical for conducting pharmacokinetic (PK) and bioanalytical studies to understand drug absorption, distribution, metabolism, and excretion.
• Facilitates metabolite identification and profiling in drug metabolism and pharmacodynamics (DMPK) research.
• Supports method development and validation in regulatory-compliant analytical laboratories.
• Enables high-accuracy therapeutic drug monitoring (TDM) and clinical research on smoking cessation agents.
• Employed in impurity profiling and stability studies of pharmaceutical formulations containing Varenicline.

Basic Information

Product Name	Varenicline-D4
CAS No.	2183239-01-0
Molecular Formula	C13H9D4N3
Molecular Weight	215.28 g/mol (for C13H9D4N3)
Synonyms	7,8,9,10-Tetradeutero-varenicline; Varenicline (phenyl-d4); 5-[(2R)-2-Azetidinylmethoxy]-2-chloropyridine (phenyl-d4); 2-Chloro-5-[(2R)-azetidin-2-ylmethoxy]pyridine (phenyl-d4); CP-526555-d4; Chantix-d4 (deuterated); Champix-d4 (deuterated); Deuterated Varenicline Internal Standard
EINECS	Contact for details

Quality Control

Our Varenicline-D4 is manufactured under strict quality systems to ensure exceptional isotopic purity and chemical integrity. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for assay, isotopic enrichment (D4), and impurity profiles. We adhere to cGMP principles for research chemicals, and our quality protocols are designed to support regulatory submissions.

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); ensure the container is sealed under an inert atmosphere after each use to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D4)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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