Description

Varenicline-D4 Dihydrochloride (Major) is a high-purity, deuterium-labeled internal standard critical for accurate quantitative analysis in pharmaceutical research and development. This stable isotope-labeled compound is essential for ensuring the precision and reliability of mass spectrometry-based bioanalytical methods. It is primarily utilized by analytical chemists and researchers in pharmaceutical companies, contract research organizations (CROs), and academic laboratories focusing on pharmacokinetics, metabolism studies, and quality control for smoking cessation therapeutics.

Application

• Internal Standard for LC-MS/MS: Serves as a critical reference compound for the precise quantification of varenicline and its metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic (PK) and Bioavailability Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical trials.
• Drug Metabolism Research: Used in metabolite identification and profiling studies to understand the metabolic pathways of varenicline.
• Quality Control and Assurance: Employed in the development and validation of robust analytical methods for drug substance and drug product testing in GMP environments.
• Forensic and Doping Control Analysis: Supports accurate detection and quantification of varenicline in specialized forensic or anti-doping applications.

Basic Information

Product Name	Varenicline-D4 Dihydrochloride (Major)
CAS No.	866823-63-4
Molecular Formula	C13H9D4ClN3•2HCl
Molecular Weight	313.64 g/mol (for free base C13H9D4ClN3)
Synonyms	7,8,9,10-Tetradeutero-varenicline dihydrochloride; Varenicline (phenyl-d4) dihydrochloride; CP-526555-d4 dihydrochloride; (2R,3R)-2,3,4,5-Tetrahydro-2,3-dimethyl-5-(5,6,7,8-tetradeutero-1,2,4-triazolo[4,3-a]pyridin-7-yl)-1H-pyrido[4,3-b]indole dihydrochloride; Varenicline-d4 (major) 2HCl; Chantix-d4 dihydrochloride internal standard.
EINECS	Contact for details

Quality Control

Every batch of Varenicline-D4 Dihydrochloride (Major) is manufactured and analyzed under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Our products undergo rigorous quality testing, including advanced spectroscopic and chromatographic methods, to ensure compliance with industry standards. Certificates of Analysis (COA) detailing batch-specific results for identity, purity (HPLC), isotopic enrichment, and other critical parameters 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. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to maintain stability and purity. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (Mass Spectrometry)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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