Description

Verlukast-D6 is a deuterated isotopologue of the leukotriene receptor antagonist Verlukast, specifically labeled with six deuterium atoms. This stable isotope-labeled compound is a critical analytical standard used for precise quantification and metabolic studies in pharmaceutical research and development. It is essential for scientists and quality control laboratories in the pharmaceutical and contract research organization (CRO) sectors who require high-purity reference materials for mass spectrometry-based assays, including pharmacokinetic studies and bioanalytical method validation.

Application

• Internal Standard for LC-MS/MS: Serves as a crucial internal standard in liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the accurate quantification of Verlukast in biological matrices like plasma, serum, and urine.
• Drug Metabolism and Pharmacokinetics (DMPK): Used in stable isotope dilution studies to investigate the absorption, distribution, metabolism, and excretion (ADME) profile of Verlukast.
• Bioanalytical Method Development and Validation: A key component in developing and validating robust, sensitive, and specific analytical methods for compliance with FDA, EMA, and ICH guidelines.
• Pharmaceutical Quality Control: Employed as a certified reference material to ensure the accuracy and precision of assay results for drug substance and product testing.
• Clinical Research: Facilitates reliable therapeutic drug monitoring and pharmacokinetic profiling during clinical trials.
• Isotope-Labeled Synthesis Intermediate: Can be used as a building block for the synthesis of more complex deuterated molecules for research purposes.

Basic Information

Product Name	Verlukast-D6
CAS No.	153698-86-3
Molecular Formula	C31H27D6ClN2O6S
Molecular Weight	~598.13 g/mol
Synonyms	Verlukast (hexadeuterated); [D6]-Verlukast; 4-[[(1R)-1-[[[3-[(D3)Acetyl](2,3,4,5-tetrahydro-2,2,4,4-tetramethyl-8-quinolinyl)thio]methyl]cyclohexyl]acetyl]amino]benzoic acid (D3 methyl ester); MK-0679-D6; L-668,019-D6; (R)-Verlukast-D6; Deuterated Verlukast
EINECS	Contact for details

Quality Control

Our Verlukast-D6 is manufactured under strict quality systems to ensure the highest standards of isotopic purity and chemical integrity. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing critical parameters such as chemical purity (by HPLC), isotopic enrichment (by MS), and residual solvent content. We adhere to relevant industry guidelines for reference materials to support your regulatory submissions. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive). For long-term storage, consider storage under an inert atmosphere. Allow the sealed vial to warm to room temperature before opening to minimize moisture condensation.

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 (MS)	≥ 98.0 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Meets ICH limits
Water Content (KF)	≤ 0.5%

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