Description

Montelukast-D6 is a deuterated internal standard of the leukotriene receptor antagonist Montelukast, specifically designed for analytical applications. This high-purity, isotopically labeled compound is essential for ensuring the accuracy and reliability of quantitative mass spectrometry analyses. It is primarily used by pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments for method development, validation, and bioanalytical studies.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of Montelukast in biological matrices (e.g., plasma, serum) during pharmacokinetic and bioequivalence studies.
• Pharmaceutical Research & Development: Used in method development and validation for drug metabolism and pharmacokinetics (DMPK) studies.
• Clinical Laboratory Analysis: Enables accurate therapeutic drug monitoring (TDM) in patient samples.
• Quality Control & Assurance: Serves as a reference standard in the quality control testing of active pharmaceutical ingredients (APIs) and finished drug products.
• Metabolite Identification: Aids in the identification and characterization of Montelukast metabolites in complex samples.
• Regulatory Compliance Testing: Supports analytical procedures required for regulatory submissions to agencies like the FDA and EMA.

Basic Information

Product Name	Montelukast-D6
CAS No.	1093746-29-2
Molecular Formula	C35H30D6ClNO3S
Molecular Weight	608.23 g/mol (deuterated form)
Synonyms	Montelukast-d6; [²H6]-Montelukast; 1-[[[(1R)-1-[3-[(1E)-2-(7-Chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic Acid-d6; (R)-Montelukast-d6; MK-0476-d6; Singulair-d6 (deuterated)
EINECS	Contact for details

Quality Control

Our Montelukast-D6 is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical integrity. Each batch is characterized by advanced analytical techniques including NMR, HPLC, and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing parameters such as chemical purity, isotopic enrichment, and chromatographic profile to support your regulatory and research needs.

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 product is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccant use and inert atmosphere.

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
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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